Zolpidem Tartrate

Zolpidem Tartrate Manufacturers

• Direct Rx
  

  ×

  Zolpidem Tartrate | Direct Rx

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS (5.1)]. The total dose of zolpidem tartrate extended-release tablets should not exceed 12.5 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.1); USE IN SPECIFIC POPULATIONS (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.1)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Zolpidem Tartrate | Bryant Ranch Prepack

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Blenheim Pharmacal, Inc.
  

  ×

  Zolpidem Tartrate | Blenheim Pharmacal, Inc.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see  Warnings and Precautions (5.1)] . The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1);  Use in Specific Populations (8.5)] .

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see  Warnings and Precautions (5.1)] .

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see  Warnings and Precautions (5.1)] . The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1);  Use in Specific Populations (8.5)] .

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see  Warnings and Precautions (5.1)] .

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Blenheim Pharmacal, Inc.
  

  ×

  Zolpidem Tartrate | Blenheim Pharmacal, Inc.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see  Warnings and Precautions (5.1)] . The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1);  Use in Specific Populations (8.5)] .

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see  Warnings and Precautions (5.1)] .

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see  Warnings and Precautions (5.1)] . The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1);  Use in Specific Populations (8.5)] .

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see  Warnings and Precautions (5.1)] .

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Direct Rx
  

  ×

  Zolpidem Tartrate | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

  ---

  2.1 Schizophrenia Adults Dose Selection

  Olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

  Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Olanzapine is not indicated for use in doses above 20 mg/day.

  Dosing in Special Populations

  The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥ 65 years of age), or who may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions (5.14), Drug Interactions (7), and Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.

  Maintenance Treatment

  The effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studies (14.1)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

  Adolescents Dose Selection

  Olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with schizophrenia was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 12.5 mg/day (mean dose of 11.1 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.

  The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.1)].

  Maintenance Treatment

  The efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.2 Bipolar I Disorder (Manic or Mixed Episodes) Adults Dose Selection for Monotherapy

  Olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

  Short-term (3 to 4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials [see Clinical Studies (14.2)].

  Maintenance Monotherapy

  The benefit of maintaining bipolar I patients on monotherapy with oral olanzapine at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial [see Clinical Studies (14.2)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

  Dose Selection for Adjunctive Treatment

  When administered as adjunctive treatment to lithium or valproate, olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals.

  Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials [see Clinical Studies (14.2)]. The safety of doses above 20 mg/day has not been evaluated in clinical trials.

  Adolescents Dose Selection

  Olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 10.7 mg/day (mean dose of 8.9 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.

  The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.2)].

  Maintenance Treatment

  The efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder

  When using olanzapine and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.

  Adults

  Olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of olanzapine 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination in adult patients with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.

  Children and Adolescents (10 to 17 years of age)

  Dosage and Administration information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s olanzapine tablets and olanzapine orally disintegrating tablets. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  Safety and efficacy of olanzapine and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of olanzapine and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.

  Table 1: Approximate Dose Correspondence Between Symbyax* and the Combination of Olanzapine and Fluoxetine * Symbyax (olanzapine/fluoxetine HCl) is a fixed-dose combination of olanzapine and fluoxetine  

  For

   

  Use in Combination

   

  Symbyax

  (mg/day)

   

  Olanzapine

  (mg/day)

   

  Fluoxetine

  (mg/day)

   

  3 mg olanzapine/25 mg fluoxetine

  6 mg olanzapine/25 mg fluoxetine

  12 mg olanzapine/25 mg fluoxetine

  6 mg olanzapine/50 mg fluoxetine

  12 mg olanzapine/50 mg fluoxetine

   

  2.5

  5

  10+2.5

  5

  10+2.5

   

  20

  20

  20

  40+10

  40+10

  While there is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.

  Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

  2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special Populations

  The starting dose of olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under < 10 years of age [see Warnings and Precautions (5.14), Drug Interactions (7), and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• Preferred Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Preferred Pharmaceuticals, Inc.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 mg or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Preferred Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Preferred Pharmaceuticals, Inc.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
  
  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Direct Rx
  

  ×

  Zolpidem Tartrate | Direct Rx

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal

  Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.

  Zolpidem tartrate tablets 5 mg are pink, film-coated, capsule-shaped, unscored, upper debossed "6468" and lower debossed "V". The 10 mg tablets are white, film-coated, capsule-shaped, unscored, upper debossed "6469" and lower debossed "V.

  Close
  No Recall

  More Info
• A-s Medication Solutions Llc
  

  ×

  Zolpidem Tartrate | A-s Medication Solutions Llc

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].  

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• A-s Medication Solutions Llc
  

  ×

  Zolpidem Tartrate | A-s Medication Solutions Llc

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate extended-release tablets should not exceed 12.5 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment  may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Zolpidem Tartrate | Remedyrepack Inc.

  

  ---

  Use the lowest dose effective for the patient (2.1) Recommended initial dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening (2.1) Geriatric patients and patients with hepatic impairment: Recommended dose is 5 mg for men and women (2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate tablets (2.3)  The effect of zolpidem tartrate tablets may be slowed if taken with or immediately after a meal (2.4)

   

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

   

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

   

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

   

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

   

  Close
  No Recall

  More Info
• Rxchange Co.
  

  ×

  Zolpidem Tartrate | Rxchange Co.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Rxchange Co.
  

  ×

  Zolpidem Tartrate | Rxchange Co.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Watson Laboratories
  

  ×

  Zolpidem Tartrate | Watson Laboratories

  

  ---

  2.1  Dosage in adults

  The dose of zolpidem tartrate tablets should be individualized.

  The recommended dose for adults is 10 mg immediately before bedtime.

  2.2  Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [seeWarnings and Precautions (5)].

  2.3  Administration with CNS depressants

  Downward dosage adjustment may be necessary when zolpidem tartrate tablets are administered with agents having known CNS-depressant effects because of the potentially additive effects [seeWarnings and Precautions (5)].

  2.4  Maximum daily dose

  The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  Close
  No Recall

  More Info
• Mutual Pharmaceutical Company, Inc.
  

  ×

  Zolpidem Tartrate | Mutual Pharmaceutical Company, Inc.

  

  ---

  2.1 Dosage in adults

  The dose of zolpidem tartrate tablets should be individualized.

  The recommended dose for adults is 10 mg immediately before bedtime.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see Warnings and Precautions (5)].

  2.3 Administration with CNS depressants

  Downward dosage adjustment may be necessary when zolpidem tartrate tablets are administered with agents having known CNS-depressant effects because of the potentially additive effects [see Warnings and Precautions (5)].

  2.4 Maximum daily dose

  The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  Close
  No Recall

  More Info
• Synthon Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Synthon Pharmaceuticals, Inc.

  

  ---

  2.1 Dosage in adults

  The dose of zolpidem tartrate tablets should be individualized.

  The recommended dose for adults is 10 mg immediately before bedtime.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see Warnings and Precautions (5)].

  2.3 Administration with CNS depressants

  Downward dosage adjustment may be necessary when zolpidem tartrate tablets are administered with agents having known CNS-depressant effects because of the potentially additive effects [see Warnings and Precautions (5)].

  2.4 Maximum daily dose

  The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  Close
  No Recall

  More Info
• Yung Shin Pharmaceutical Industries, Co., Ltd.
  

  ×

  Zolpidem Tartrate | Yung Shin Pharmaceutical Industries, Co., Ltd.

  

  ---

  2.1 Dosage in adults

  The dose of zolpidem tartrate tablets should be individualized.

  The recommended dose for adults is 10 mg immediately before bedtime.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets . Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see Warnings and Precautions (5)].

  2.3 Administration with CNS depressants:

  Downward dosage adjustment may be necessary when zolpidem tartrate tablets is administered with agents having known CNS-depressant effects because of the potentially additive effects [see Warnings and Precautions (5)].

  2.4 Maximum daily dose:

  The total zolpidem tartrate tablets dose should not exceed 10 mg per day.

  Close
  No Recall

  More Info
• Invagen Pharmaceuticals Inc.,
  

  ×

  Zolpidem Tartrate | Invagen Pharmaceuticals Inc.,

  

  ---

  2.1 Dosage in adults

  The dose of zolpidem tartrate tablets should be individualized.

  The recommended dose for adults is 10 mg immediately before bedtime.

  Zolpidem tartrate tablets should not be administered with or immediately after a meal.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see Warnings and Precautions (5)].

  2.3 Administration with CNS depressants:

  Downward dosage adjustment may be necessary when zolpidem tartrate tablets are administered with agents having known CNS-depressant effects because of the potentially additive effects [see Warnings and Precautions (5)].

  2.4 Maximum daily dose:

  The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  Close
  No Recall

  More Info
• Caraco Pharmaceutical Laboratories, Ltd.
  

  ×

  Zolpidem Tartrate | Caraco Pharmaceutical Laboratories, Ltd.

  

  ---

  
  The dose of zolpidem tartrate tablets should be individualized. 2.1 Dosage in adults
  The recommended dose for adults is 10 mg once daily immediately before bedtime.
  The total zolpidem tartrate tablets dose should not exceed 10 mg per day. 2.2 Special populations
  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)]. 2.3 Use with CNS depressants
  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)]. 2.4 Administration
  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• American Health Packaging
  

  ×

  Zolpidem Tartrate | American Health Packaging

  

  ---

  2.1 Dosage in adults

  The dose of zolpidem tartrate tablets should be individualized.

  The recommended dose for adults is 10 mg immediately before bedtime.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see Warnings and Precautions (5) ].

  2.3 Administration with CNS depressants:

  Downward dosage adjustment may be necessary when zolpidem tartrate tablets are administered with agents having known CNSdepressant effects because of the potentially additive effects [see Warnings and Precautions (5)].

  2.4 Maximum daily dose:

  The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  Close
  No Recall

  More Info
• Rebel Distributors Corp.
  

  ×

  Zolpidem Tartrate | Rebel Distributors Corp.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Physicians Total Care, Inc.
  

  ×

  Zolpidem Tartrate | Physicians Total Care, Inc.

  

  ---

  The dose of zolpidem tartrate extended-release tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose of zolpidem tartrate extended-release tablets for adults is 12.5 mg once daily immediately before bedtime.  The total zolpidem tartrate extended-release tablets dose should not exceed 12.5 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustments may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Physicians Total Care, Inc.
  

  ×

  Zolpidem Tartrate | Physicians Total Care, Inc.

  

  ---

  The dose of Zolpidem Tartrate Extended-Release Tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose of Zolpidem Tartrate Extended-Release Tablets for adults is 12.5 mg once daily immediately before bedtime. The total Zolpidem Tartrate Extended-Release Tablets dose should not exceed 12.5 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. The recommended dose of Zolpidem Tartrate Extended-Release Tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustments may be necessary when Zolpidem Tartrate Extended-Release Tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  Zolpidem Tartrate Extended-Release Tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Zolpidem Tartrate Extended-Release Tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Carlsbad Technology, Inc.
  

  ×

  Zolpidem Tartrate | Carlsbad Technology, Inc.

  

  ---

  2.1 Dosage in adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)] . The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
  The recommended initial doses for women and men are different because zolpidem tartrate clearance is lower in women.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)] .

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)] .

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Redpharm Drug, Inc.
  

  ×

  Zolpidem Tartrate | Redpharm Drug, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults
  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablets dose should not exceed 10 mg per day. 2.2 Special populations
  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)]. 2.3 Use with CNS depressants
  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)]. 2.4 Administration
  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Redpharm Drug Inc.
  

  ×

  Zolpidem Tartrate | Redpharm Drug Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Redpharm Drug Inc.
  

  ×

  Zolpidem Tartrate | Redpharm Drug Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressantsDosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)]. 2.4 AdministrationThe effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal. 2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressantsDosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)]. 2.4 AdministrationThe effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Redpharm Drug Inc.
  

  ×

  Zolpidem Tartrate | Redpharm Drug Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Pd-rx Pharmaceuticals, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• H.j. Harkins Company, Inc.
  

  ×

  Zolpidem Tartrate | H.j. Harkins Company, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• St Marys Medical Park Pharmacy
  

  ×

  Zolpidem Tartrate | St Marys Medical Park Pharmacy

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Pd-rx Pharmaceuticals, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Zolpidem Tartrate | Cardinal Health

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see  WARNINGS AND PRECAUTIONS (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see  WARNINGS AND PRECAUTIONS (5.5)].

  2.4 Administration Daily Dose

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Zolpidem Tartrate | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Roxane Laboratories, Inc
  

  ×

  Zolpidem Tartrate | Roxane Laboratories, Inc

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of Zolpidem Tartrate Tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem in both of these patient populations is 5 mg once daily immediately before bedtime [seeWarnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when Zolpidem Tartrate Tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of Zolpidem Tartrate Tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Physicians Total Care, Inc.
  

  ×

  Zolpidem Tartrate | Physicians Total Care, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults 

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablets dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime. [see Warnings and Precautions (5.6 )].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Dispensing Solutions, Inc.
  

  ×

  Zolpidem Tartrate | Dispensing Solutions, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Stat Rx Usa Llc
  

  ×

  Zolpidem Tartrate | Stat Rx Usa Llc

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Mylan Institutional Inc.
  

  ×

  Zolpidem Tartrate | Mylan Institutional Inc.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 mg or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Life Line Home Care Services, Inc.
  

  ×

  Zolpidem Tartrate | Life Line Home Care Services, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Zolpidem Tartrate | Cardinal Health

  

  ---

  2.1 Dosage in adults

  The dose of zolpidem tartrate tablets should be individualized.

  The recommended dose for adults is 10 mg immediately before bedtime.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see Warnings and Precautions (5) ].

  2.3 Administration with CNS depressants:

  Downward dosage adjustment may be necessary when zolpidem tartrate tablets are administered with agents having known CNSdepressant effects because of the potentially additive effects [see Warnings and Precautions (5)].

  2.4 Maximum daily dose:

  The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  Close
  No Recall

  More Info
• Unit Dose Services
  

  ×

  Zolpidem Tartrate | Unit Dose Services

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime . [see ] Warnings and Precautions (5.6)

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects . [see ] Warnings and Precautions (5.5)

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime . [see ] Warnings and Precautions (5.6)

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects . [see ] Warnings and Precautions (5.5)

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Zolpidem Tartrate | Cardinal Health

  

  ---

   

   The dose of zolpidem tartrate tablets should be individualized.

   

   

   

   

   

   

   

  2.1 Dosage in adults 

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablets dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime. [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

  ×

  Zolpidem Tartrate | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

  ---

  The dose of zolpidem should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem in both of these patient populations is 5 mg once daily immediately before bedtime [see 5.6 Special Populations].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem is combined with other CNS depressant drugs because of the potentially additive effects [see 5.5 CNS Depressant Effects].

  2.4 Administration

  The effect of zolpidem may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Stat Rx Usa Llc
  

  ×

  Zolpidem Tartrate | Stat Rx Usa Llc

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Pd-rx Pharmaceuticals, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Mckesson Contract Packaging
  

  ×

  Zolpidem Tartrate | Mckesson Contract Packaging

  

  ---

   The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg immediately before bedtime. Zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime. [see WARNINGS AND PRECAUTIONS (5)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive affects [see WARNINGS AND PRECAUTIONS (5.5) ].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Aidarex Pharmaceuticals Llc
  

  ×

  Zolpidem Tartrate | Aidarex Pharmaceuticals Llc

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Zolpidem Tartrate | Bryant Ranch Prepack

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Zolpidem Tartrate | Bryant Ranch Prepack

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Major Pharmaceuticals
  

  ×

  Zolpidem Tartrate | Kingdom Animalia, Llc Dba Hourglass Cosmetics

  

  ---

  Directions Apply liberally 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating reapply at least every 2 hours. Sun Protection Measures

  Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:

  limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

  Close
  No Recall

  More Info
• Wockhardt Limited
  

  ×

  Zolpidem Tartrate | Wockhardt Limited

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablets dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablet is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Wockhardt Usa Llc.
  

  ×

  Zolpidem Tartrate | Wockhardt Usa Llc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablets dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablet is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Zolpidem Tartrate | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Preferred Pharmaceuticals, Inc
  

  ×

  Zolpidem Tartrate | American Health Packaging

  

  ---

  2.1 Schizophrenia

  Adults

  Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should 4 generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended. 

  Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Olanzapine is not indicated for use in doses above 20 mg/day. 

  Dosing in Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients. 

  Maintenance Treatment — The effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studies (14.1)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. 

  Adolescents

  Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with schizophrenia was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 12.5 mg/day (mean dose of 11.1 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.  

  The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.1)].

  Maintenance Treatment — The efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.2 Bipolar I Disorder (Manic or Mixed Episodes)

  Adults

  Dose Selection for Monotherapy — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended. 

  Short-term (3 to 4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials [see Clinical Studies (14.2)]. 

  Maintenance Monotherapy — The benefit of maintaining bipolar I patients on monotherapy with oral olanzapine at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial [see Clinical Studies (14.2)]. The physician who elects to use olanzapine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. 

  Dose Selection for Adjunctive Treatment — When administered as adjunctive treatment to lithium or valproate, oral olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals. 

  Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials [see Clinical Studies (14.2)]. The safety of doses above 20 mg/day has not been evaluated in clinical trials. 

  Adolescents

  Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 10.7 mg/day (mean dose of 8.9 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.  

  The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.2)].  

  Maintenance Treatment — The efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder

  When using olanzapine and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. 

  Adults

  Oral olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral olanzapine 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination in adult patients with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.

  Children and Adolescents (10 to 17 years of age)

  Dosage and Administration information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s olanzapine tablets. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  Safety and efficacy of olanzapine and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of olanzapine and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability. 

  Table 1: Approximate Dose Correspondence Between Symbyaxa and the Combination of Olanzapine and Fluoxetine  a Symbyax (olanzapine/fluoxetine HCl) is a fixed-dose combination of olanzapine and fluoxetine. 

  For Symbyax
  (mg/day)

  Use in Combination

  Olanzapine
  (mg/day)

  Fluoxetine
  (mg/day)

  3 mg olanzapine/25 mg fluoxetine

  2.5

  20

  6 mg olanzapine/25 mg fluoxetine

  5

  20

  12 mg olanzapine/25 mg fluoxetine

  10+2.5

  20

  6 mg olanzapine/50 mg fluoxetine

  5

  40+10

  12 mg olanzapine/50 mg fluoxetine

  10+2.5

  40+10

  While there is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy. 

  Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

  2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special Populations

  The starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under < 10 years of age. [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• Dispensing Solutions, Inc.
  

  ×

  Zolpidem Tartrate | Dispensing Solutions, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Zolpidem Tartrate | Bryant Ranch Prepack

  

  ---

  The dose of zolpidem tartrate extended-release tablets, USP should be individualized.

  2.1 Dosage in Adults

  The recommended dose of zolpidem tartrate extended-release tablets for adults is 12.5 mg once daily immediately before bedtime. The total zolpidem tartrate extended-release tablets dose should not exceed 12.5 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6 )].

  2.3 Use With CNS Depressants

  Dosage adjustments may be necessary when zolpidem tartrate extended-release tablet is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.5)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Dr. Reddy’s Laboratories Limited
  

  ×

  Zolpidem Tartrate | Dr. Reddy's Laboratories Limited

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablets dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime (see WARNINGS AND PRECAUTIONS (5.6)).

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects (see WARNINGS AND PRECAUTIONS (5.5)).

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after meal.

  Close
  No Recall

  More Info
• Watson Laboratories, Inc.
  

  ×

  Zolpidem Tartrate | Watson Laboratories, Inc.

  

  ---

  The dose of zolpidem tartrate extended-release tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose of zolpidem tartrate extended-release tablets for adults is 12.5 mg once daily immediately before bedtime. The total zolpidem tartrate extended-release tablets dose should not exceed 12.5 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustments may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Zolpidem Tartrate | Cardinal Health

  

  ---

  2.1 Recommended Dose Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

  The recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily.

  Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

  The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.

  • In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days. • In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days. Treatment of DVT and PE

  The recommended dose of ELIQUIS is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.

  Reduction in the Risk of Recurrence of DVT and PE

  The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE [see Clinical Studies (14.3)].

  2.2 Dosage Adjustments

  In patients with nonvalvular atrial fibrillation: The recommended dose of ELIQUIS is 2.5 mg twice daily in patients with any 2 of the following characteristics:

  • age ≥80 years • body weight ≤60 kg • serum creatinine ≥1.5 mg/dL

  Coadministration with strong dual CYP3A4 and P-gp inhibitors: For patients receiving ELIQUIS doses greater than 2.5 mg twice daily, reduce the dose by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) [see Clinical Pharmacology (12.3)].

  In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp [see Drug Interactions (7.1)].

  2.3 Missed Dose

  If a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

  2.4 Temporary Interruption for Surgery and Other Interventions

  ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.

  2.5 Converting from or to ELIQUIS

  Switching from warfarin to ELIQUIS: Warfarin should be discontinued and ELIQUIS started when the international normalized ratio (INR) is below 2.0.

  Switching from ELIQUIS to warfarin: ELIQUIS affects INR, so that initial INR measurements during the transition to warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue ELIQUIS and begin both a parenteral anticoagulant and warfarin at the time the next dose of ELIQUIS would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

  Switching between ELIQUIS and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

  2.6 Hepatic Impairment

  No dose adjustment is required in patients with mild hepatic impairment.

  Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with ELIQUIS in these patients, dosing recommendations cannot be provided [see Clinical Pharmacology (12.2)].

  ELIQUIS is not recommended in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

  2.7 Renal Impairment

  The dosing adjustment for patients with moderate renal impairment and nonvalvular atrial fibrillation is described above [see Dosage and Administration (2.2)]. The recommended dose for nonvalvular atrial fibrillation patients with end-stage renal disease (ESRD) maintained on hemodialysis is 5 mg twice daily. Reduce dose to 2.5 mg twice daily if one of the following patient characteristics (age ≥80 years or body weight ≤60 kg) is present [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  No dose adjustment is required for the following indications:

  • for the prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery. • for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE. 2.8 Administration Options

  For patients who are unable to swallow whole tablets, 5 mg and 2.5 mg ELIQUIS tablets may be crushed and suspended in 60 mL D5W and immediately delivered through a nasogastric tube (NGT) [see Clinical Pharmacology (12.3)]. Information regarding the administration of crushed and suspended ELIQUIS tablets swallowed by mouth is not available.

  2.1 Recommended Dose Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

  The recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily.

  Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

  The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.

  • In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days. • In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days. Treatment of DVT and PE

  The recommended dose of ELIQUIS is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.

  Reduction in the Risk of Recurrence of DVT and PE

  The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE [see Clinical Studies (14.3)].

  2.2 Dosage Adjustments

  In patients with nonvalvular atrial fibrillation: The recommended dose of ELIQUIS is 2.5 mg twice daily in patients with any 2 of the following characteristics:

  • age ≥80 years • body weight ≤60 kg • serum creatinine ≥1.5 mg/dL

  Coadministration with strong dual CYP3A4 and P-gp inhibitors: For patients receiving ELIQUIS doses greater than 2.5 mg twice daily, reduce the dose by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) [see Clinical Pharmacology (12.3)].

  In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp [see Drug Interactions (7.1)].

  2.3 Missed Dose

  If a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

  2.4 Temporary Interruption for Surgery and Other Interventions

  ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.

  2.5 Converting from or to ELIQUIS

  Switching from warfarin to ELIQUIS: Warfarin should be discontinued and ELIQUIS started when the international normalized ratio (INR) is below 2.0.

  Switching from ELIQUIS to warfarin: ELIQUIS affects INR, so that initial INR measurements during the transition to warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue ELIQUIS and begin both a parenteral anticoagulant and warfarin at the time the next dose of ELIQUIS would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

  Switching between ELIQUIS and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

  2.6 Hepatic Impairment

  No dose adjustment is required in patients with mild hepatic impairment.

  Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with ELIQUIS in these patients, dosing recommendations cannot be provided [see Clinical Pharmacology (12.2)].

  ELIQUIS is not recommended in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

  2.7 Renal Impairment

  The dosing adjustment for patients with moderate renal impairment and nonvalvular atrial fibrillation is described above [see Dosage and Administration (2.2)]. The recommended dose for nonvalvular atrial fibrillation patients with end-stage renal disease (ESRD) maintained on hemodialysis is 5 mg twice daily. Reduce dose to 2.5 mg twice daily if one of the following patient characteristics (age ≥80 years or body weight ≤60 kg) is present [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  No dose adjustment is required for the following indications:

  • for the prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery. • for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.

  Close
  No Recall

  More Info
• A-s Medication Solutions Llc
  

  ×

  Zolpidem Tartrate | A-s Medication Solutions Llc

  

  ---

  The dose of zolpidem tartrate extended-release tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose of zolpidem tartrate extended-release tablets for adults is 12.5 mg once daily immediately before bedtime.  The total zolpidem tartrate extended-release tablets dose should not exceed 12.5 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustments may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Kaiser Foundation Hospitals
  

  ×

  Zolpidem Tartrate | Kaiser Foundation Hospitals

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Sandoz Inc
  

  ×

  Zolpidem Tartrate | Mylan Pharmaceuticals Inc.

  

  ---

  2.1 Adults

  The recommended starting dose for fluvoxamine maleate tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of fluvoxamine maleate tablets in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

  2.2 Pediatric Population (children and adolescents)

  The recommended starting dose for fluvoxamine maleate tablets in pediatric populations (ages 8 to 17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of fluvoxamine maleate tablets in OCD, pediatric patients (ages 8 to 17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

  2.3 Elderly or Hepatically Impaired Patients

  Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.

  2.4 Pregnant Women During the Third Trimester

  Neonates exposed to fluvoxamine maleate tablets and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding and may be at risk for persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1)]. When treating pregnant women with fluvoxamine maleate tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

  2.5 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluvoxamine maleate tablets. Conversely, at least 14 days should be allowed after stopping fluvoxamine maleate tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.2)].

  2.6 Use of Fluvoxamine Maleate Tablets with Other MAOIs such as Linezolid or Methylene Blue

  Do not start fluvoxamine maleate tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.2)].

  In some cases, a patient already receiving fluvoxamine maleate tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluvoxamine maleate tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluvoxamine maleate tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluvoxamine maleate tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].

  2.7 Maintenance/Continuation Extended Treatment

  It is generally agreed that obsessive compulsive disorder requires several months or longer of sustained pharmacologic therapy. The benefit of maintaining patients with OCD on fluvoxamine maleate tablets after achieving a response for an average duration of about 4 weeks in a 10-week single-blind phase during which patients were titrated to effect was demonstrated in a controlled trial [see Clinical Trials (14.2)]. The physician who elects to use fluvoxamine maleate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

  2.8 Discontinuation of Treatment with Fluvoxamine Maleate Tablets

  Symptoms associated with discontinuation of other SSRIs or SNRIs have been reported [see Warnings and Precautions (5.9)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Zolpidem Tartrate | Remedyrepack Inc.

  

  ---

  Adult dose: 10 mg once daily immediately before bedtime (2.1) Elderly/debilitated patients/hepatically impaired: 5 mg once daily immediately before bedtime (2.2) Downward dosage adjustment may be necessary when used with CNS depressants (2.3) Should not be taken with or immediately after a meal (2.4)

   

  The dose of zolpidem tartrate tablets should be individualized.

   

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

   

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

   

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

   

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

   

  Close
  No Recall

  More Info
• Teva Pharmaceuticals Usa Inc
  

  ×

  Zolpidem Tartrate | Glaxosmithkline Llc

  

  ---

  2.1 Recommended Dosage

  This product is for intravenous use only.

  The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for bone marrow transplant, or the patient no longer continued to benefit from treatment.

  Adult Dosage: The recommended adult dose of ARRANON is 1,500 mg/m² administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. ARRANON is administered undiluted.

  Pediatric Dosage: The recommended pediatric dose of ARRANON is 650 mg/m² administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. ARRANON is administered undiluted.

  2.2 Dosage Modification

  Administration of ARRANON should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria Grade 2 or greater. Dosage may be delayed for other toxicity including hematologic toxicity. [See Boxed Warning, Warnings and Precautions (5.1, 5.2).]

  2.3 Adjustment of Dose in Special Populations

  ARRANON has not been studied in patients with renal or hepatic dysfunction [see Use in Specific Populations (8.6, 8.7)]. No dose adjustment is recommended for patients with a creatinine clearance (CLcr) ≥50 mL/min [see Clinical Pharmacology (12.3)]. There are insufficient data to support a dose recommendation for patients with a CLcr <50 mL/min.

  2.4 Prevention of Hyperuricemia

  Appropriate measures (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia [see Warnings and Precautions (5.4)].

  2.5 Instructions for Handling, Preparation, and Administration

  Handling: ARRANON is a cytotoxic agent. Caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended. Proper aseptic technique should be used. Guidelines for proper handling and disposal of anticancer drugs have been published.1-4

  Preparation and Administration: Do not dilute ARRANON prior to administration. The appropriate dose of ARRANON is transferred into polyvinylchloride (PVC) infusion bags or glass containers and administered as a 2-hour infusion in adult patients and as a 1-hour infusion in pediatric patients.

  Prior to administration, inspect the drug product visually for particulate matter and discoloration.

  Stability: ARRANON Injection is stable in polyvinylchloride (PVC) infusion bags and glass containers for up to 8 hours at up to 30° C.

  Close
  No Recall

  More Info
• Actavis Elizabeth Llc
  

  ×

  Zolpidem Tartrate | Major Pharmaceuticals

  

  ---

  to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor
  

  Close
  No Recall

  More Info
• Mylan Pharmaceuticals Inc.
  

  ×

  Zolpidem Tartrate | Onset Dermatologics Llc

  

  ---

  IMPORTANT: Prime Can Before Initial Use.
  To Prime Can: Shake can well (until product moves inside can). Firmly strike bottom of can onto palm of hand at least 3 times. Hold can upright and direct initial spray to a non-skin surface. Until foam dispenses, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.
  WASH-OFF APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Holding can upright, dispense Clarifoam® EF into palm of hand. Massage the dispensed foam into the affected area and wait 10 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 3
  times daily, or as directed by a physician. Wipe off any excess foam from actuator after use.
  LEAVE-ON APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Holding can upright, dispense Clarifoam® EF into the palm of hand. Massage the dispensed foam into the affected area 1 to 3 times daily, or as directed by a physician. Wipe off any excess foam from actuator after use.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Zolpidem Tartrate | Remedyrepack Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

   

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

   

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

   

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

   

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

   

  Close
  No Recall

  More Info
• Dispensing Solutions, Inc.
  

  ×

  Zolpidem Tartrate | Dispensing Solutions, Inc.

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Ranbaxy Pharmaceuticals Inc.
  

  ×

  Zolpidem Tartrate | American Sales Company

  

  ---

  • this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle. • pull yellow part of syringe until it reaches and stays at the correct dose • dispense liquid slowly into child’s mouth, toward inner cheek • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • replace cap tightly to maintain child resistance

  Dosing Chart

  Weight (lb)

  Age (yr)

  Dose (mL)*

  under 24

  under 2 years

  ask a doctor

  24-35

  2-3 years

  5 mL

  *or as directed by a doctor

  Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

  Close
  No Recall

  More Info
• Preferred Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Cvs Pharmacy

  

  ---

  swallow tablet(s) with a glass of water swallow tablet(s) whole, do not crush, break, or chew   adults and children 12 years of age and older   take 2 tablets once or twice daily   children 6 to under 12 years of age   take 1 tablet once or twice daily   children under 6 years of age   ask a doctor

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Pd-rx Pharmaceuticals, Inc.

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Northstar Rx Llc
  

  ×

  Zolpidem Tartrate | 1st Class Pharmaceuticals

  

  ---

  Apply directly to affected area. Do
  not use more than four times per day.
  Children under 12 years of age:
  Consult a Physician.

  Close
  No Recall

  More Info
• Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc
  

  ×

  Zolpidem Tartrate | Sandoz Inc

  

  ---

  2.1 Schizophrenia

  Dose Selection

  Ziprasidone hydrochloride capsules should be administered at an initial daily dose of 20 mg twice daily with food. In some patients, daily dosage may subsequently be adjusted on the basis of individual clinical status up to 80 mg twice daily. Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state is achieved within 1 to 3 days. In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment.

  Efficacy in schizophrenia was demonstrated in a dose range of 20 mg to 100 mg twice daily in short-term, placebo-controlled clinical trials. There were trends toward dose response within the range of 20 mg to 80 mg twice daily, but results were not consistent. An increase to a dose greater than 80 mg twice daily is not generally recommended. The safety of doses above 100 mg twice daily has not been systematically evaluated in clinical trials [see CLINICAL STUDIES (14.1)].

  Maintenance Treatment

  While there is no body of evidence available to answer the question of how long a patient treated with ziprasidone should remain on it, a maintenance study in patients who had been symptomatically stable and then randomized to continue ziprasidone or switch to placebo demonstrated a delay in time to relapse for patients receiving ziprasidone hydrochloride capsules. [see CLINICAL STUDIES (14.1)]. No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.4 Dosing in Special Populations

  Oral: Dosage adjustments are generally not required on the basis of age, gender, race, or renal or hepatic impairment. Ziprasidone hydrochloride capsules are not approved for use in children or adolescents.

  Close
  No Recall

  More Info
• Aurobindo Pharma Limited
  

  ×

  Zolpidem Tartrate | Aurobindo Pharma Limited

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
  
  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration
  

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Apotex Corp.
  

  ×

  Zolpidem Tartrate | Apotex Corp.

  

  ---

  2.1 Dosage in Adults 

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Zolpidem Tartrate | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate extended-release tablets should not exceed 12.5 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment  may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Remedyrepack Inc.
  

  ×

  Zolpidem Tartrate | Remedyrepack Inc.

  

  ---

  Adult dose: 10 mg once daily immediately before bedtime (2.1) Elderly/debilitated patients/hepatically impaired: 5 mg once daily immediately before bedtime (2.2) Downward dosage adjustment may be necessary when used with CNS depressants (2.3) Should not be taken with or immediately after a meal (2.4)

   

  The dose of zolpidem tartrate tablets should be individualized.

   

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate dose should not exceed 10 mg per day.

   

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

   

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

   

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

   

  Close
  No Recall

  More Info
• Unit Dose Services
  

  ×

  Zolpidem Tartrate | Unit Dose Services

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime . [see ] Warnings and Precautions (5.6)

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects . [see ] Warnings and Precautions (5.5)

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime . [see ] Warnings and Precautions (5.6)

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects . [see ] Warnings and Precautions (5.5)

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Apotheca, Inc
  

  ×

  Zolpidem Tartrate | Apotheca, Inc

  

  ---

  Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions); Use in Specific Populations].

  Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions].

  Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  DOSAGE FORMS AND STRENGTHS

  Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.

  Zolpidem tartrate tablets 5 mg are pink, film-coated, capsule-shaped, unscored, upper debossed "6468" and lower debossed "V". The 10 mg tablets are white, film-coated, capsule-shaped, unscored, upper debossed "6469" and lower debossed "V".

  CONTRAINDICATIONS

  Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions].

  Close
  No Recall

  More Info
• American Health Packaging
  

  ×

  Zolpidem Tartrate | Procter & Gamble Manufacturing Company

  

  ---

  apply to underarms only apply two clicks of product to underarms at morning and bedtime

  Close
  No Recall

  More Info
• Mckesson Packaging Services Business Unit Of Mckesson Corporation
  

  ×

  Zolpidem Tartrate | Mckesson Packaging Services Business Unit Of Mckesson Corporation

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablets dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• American Health Packaging
  

  ×

  Zolpidem Tartrate | G&w Laboratories, Inc.

  

  ---

  Dosage should be adjusted according to severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls.
  
  The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of Hycet (providing 0.135 mg/kg of hydrocodone bitartrate and 5.85 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.
  
   
   The total daily dosage for children should not exceed 6 doses per day.
  
  It is of utmost importance that the dose of Hycet be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that care givers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage. 

  Close
  No Recall

  More Info
• Direct Rx
  

  ×

  Zolpidem Tartrate | Direct Rx

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Aphena Pharma Solutions – Tennessee, Llc
  

  ×

  Zolpidem Tartrate | Aphena Pharma Solutions - Tennessee, Llc

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Sandoz Inc
  

  ×

  Zolpidem Tartrate | Sandoz Inc

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.1); USE IN SPECIFIC POPULATIONS (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Aphena Pharma Solutions – Tennessee, Llc
  

  ×

  Zolpidem Tartrate | Aphena Pharma Solutions - Tennessee, Llc

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of Zolpidem Tartrate Extended-Release Tablets should not exceed 12.5 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem Tartrate Extended-Release Tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when Zolpidem Tartrate Extended-Release Tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  Zolpidem Tartrate Extended-Release Tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Zolpidem Tartrate Extended-Release Tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Zolpidem Tartrate | Cardinal Health

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in Adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Zolpidem Tartrate | Cardinal Health

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 mg or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Proficient Rx Lp
  

  ×

  Zolpidem Tartrate | Proficient Rx Lp

  

  ---

  2.1Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS (5.1)]. The total dose of zolpidem tartrate extended-release tablet, USP should not exceed 12.5 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.1); USE IN SPECIFIC POPULATIONS (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.1)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Qualitest Pharmaceuticals
  

  ×

  Zolpidem Tartrate | Qualitest Pharmaceuticals

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Lupin Pharmaceuticals, Inc.
  

  ×

  Zolpidem Tartrate | Richmond Pharmaceuticals, Inc.

  

  ---

  Under no circumstances should ribavirin capsules be opened, crushed, or broken. Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3)]. Ribavirin capsules should not be used in patients with creatinine clearance < 50 mL/min.

  2.1 Ribavirin/Peginterferon alfa-2b Combination Therapy

  Adult Patients

  The recommended dose of peginterferon alfa-2b is 1.5 mcg/kg/week subcutaneously in combination with 800 to 1400 mg ribavirin capsules orally based on patient body weight (see Table 1). The volume of peginterferon alfa-2b to be injected depends on the strength of peginterferon alfa-2b and patient’s body weight (see Table 1).

  Duration of Treatment – Interferon Alpha-naïve Patients

  The treatment duration for patients with genotype 1 is 48 weeks. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks, or if HCV-RNA remains detectable after 24 weeks of therapy. Patients with genotype 2 and 3 should be treated for 24 weeks.

  Duration of Treatment – Retreatment with Peginterferon alfa-2b/Ribavirin of Prior Treatment Failures

  The treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype. Re-treated patients who fail to achieve undetectable HCV-RNA at week 12 of therapy, or whose HCV-RNA remains detectable after 24 weeks of therapy, are highly unlikely to achieve SVR and discontinuation of therapy should be considered [see Clinical Studies (14.1)].

  Table 1: Recommended Ribavirin/Peginterferon alfa-2b Combination Therapy Dosing (Adults) * When reconstituted as directed. † For patients weighing >105 kg (>231 pounds), the peginterferon alfa-2b dose of 1.5 mcg/kg/week should be calculated based on an individual patient weight. Two vials of peginterferon alfa-2b may be necessary to provide the dose.

  Body weight       kg (lbs)

  Peginterferon    alfa-2b Vial Strength to Use

  Amount of Peginterferon alfa-2b (mcg) to Administer

  Volume (mL)* of Peginterferon    alfa-2b to Administer

  Ribavirin Capsules Daily Dose

  Ribavirin    Number of Capsules

  <40
  (<87)

  50 mcg per
  0.5 mL

  50

  0.5

  800 mg/day

  2 x 200 mg capsules A.M.

  2 x 200 mg capsules P.M.

  40-50
  (87-111)

  80 mcg per
  0.5 mL

  64

  0.4

  800 mg/day

  2 x 200 mg capsules A.M.

  2 x 200 mg capsules P.M.

  51-60
  (112-133)

  80 mcg per
  0.5 mL

  80

  0.5

  800 mg/day

  2 x 200 mg capsules A.M.

  2 x 200 mg capsules P.M.

  61-65
  (134-144)

  120 mcg per
  0.5 mL

  96

  0.4

  800 mg/day

  2 x 200 mg capsules A.M.

  2 x 200 mg capsules P.M.

  66-75
  (145-166)

  120 mcg per
  0.5 mL

  96

  0.4

  1000 mg/day

  2 x 200 mg capsules A.M.

  3 x 200 mg capsules P.M.

  76-80
  (167-177)

  120 mcg per
  0.5 mL

  120

  0.5

  1000 mg/day

  2 x 200 mg capsules A.M.

  3 x 200 mg capsules P.M.

  81-85
  (178-187)

  120 mcg per
  0.5 mL

  120

  0.5

  1200 mg/day

  3 x 200 mg capsules A.M.

  3 x 200 mg capsules P.M.

  86-105
  (188-231)

  150 mcg per
  0.5 mL

  150

  0.5

  1200 mg/day

  3 x 200 mg capsules A.M.

  3 x 200 mg capsules P.M.

  >105
  (>231)

  †

  †

  †

  1400 mg/day

  3 x 200 mg capsules A.M.

  4 x 200 mg capsules P.M.

  Pediatric Patients

  Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ribavirin capsules. The recommended dose of peginterferon alfa-2b is 60 mcg/m2/week subcutaneously in combination with 15 mg/kg/day of ribavirin orally in two divided doses (see Table 2) for pediatric patients ages 3-17 years. Patients who reach their 18th birthday while receiving peginterferon alfa-2b/ribavirin should remain on the pediatric dosing regimen. The treatment duration for patients with genotype 1 is 48 weeks. Patients with genotype 2 and 3 should be treated for 24 weeks.

  Table 2: Recommended Ribavirin Capsules* Dosing in Combination Therapy (Pediatrics) * Ribavirin capsules to be used in combination with Peginterferon alfa-2b 60 mcg/m 2 weekly.

  Body weight    kg (lbs)

  Ribavirin Capsules 
  Daily Dose

  Ribavirin Number of Capsules

  47–59
  (103–131)

  800
  mg/day

  2 x 200 mg capsules A.M.  
  2 x 200 mg capsules P.M.

  60–73
  (132–162)

  1000 mg/day

  2 x 200 mg capsules A.M.
  3 x 200 mg capsules P.M.

  >73
  (>162)

  1200 mg/day

  3 x 200 mg capsules A.M.
  3 x 200 mg capsules P.M.

  2.2 Ribavirin/Interferon alfa-2b Combination Therapy

  Adults

  Duration of Treatment – Interferon Alpha-naïve Patients

  The recommended dose of interferon alfa-2b is 3 million IU three times weekly subcutaneously. The recommended dose of ribavirin depends on the patient’s body weight (refer to Table 3). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1), Adverse Reactions (6.1), and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

  Duration of Treatment – Retreatment with Interferon alfa-2b/Ribavirin in Relapse Patients

  In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks.

  Table 3. Recommended Dosing

  Body weight    

  Ribavirin capsules

  ≤75 kg

  2 times 200 mg capsules A.M.
  3 times 200 mg capsules P.M.
  daily orally

  >75 kg

  3 times 200 mg capsules A.M.
  3 times 200 mg capsules P.M.
  daily orally

  Pediatrics

  The recommended dose of ribavirin capsules is 15 mg/kg per day orally (divided dose A.M. and P.M.). Refer to Table 2 for Pediatric Dosing of ribavirin capsules in combination with interferon alfa-2b. Interferon alfa-2b for Injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously. Refer to the adult dosing table for > 61 kg body weight.

  The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.

  2.3 Laboratory Tests

  The following laboratory tests are recommended for all patients treated with ribavirin capsules, prior to beginning treatment and then periodically thereafter.

  • Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [see Warnings and Precautions (5.2, 5.7)], complete and differential white blood cell counts, and platelet count. • Blood chemistries - liver function tests and TSH. • Pregnancy - including monthly monitoring for women of childbearing potential. • ECG [see Warnings and Precautions (5.2)]. 2.4 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/interferon alfa-2b therapy or ribavirin/peginterferon alfa-2b therapy, modified, or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued. Dose reduction of peginterferon alfa-2b in adult patients on ribavirin/peginterferon alfa-2b combination therapy is accomplished in a two-step process from the original starting dose of 1.5 mcg/kg/week, to 1 mcg/kg/week, then to 0.5 mcg/kg/week, if needed. Dose reduction of peginterferon alfa-2b in adults may be accomplished by utilizing a lower dose strength or administering a lesser volume as shown in Table 4.

  In the adult combination therapy study 2 dose reductions occurred in 42% of subjects receiving peginterferon alfa-2b 1.5 mcg/kg plus ribavirin 800 mg daily including 57% of those subjects weighing 60 kg or less. In Study 4, 16% of subjects had a dose reduction of peginterferon alfa-2b to 1 mcg/kg in combination with ribavirin, with an additional 4% requiring the second dose reduction of peginterferon alfa-2b to 0.5 mcg/kg due to adverse events [see Adverse Reactions (6.1)].

  Table 4: Two-Step Dose Reduction of Peginterferon alfa-2b in Combination Therapy in Adults * When reconstituted as directed † Must use vial. Minimum delivery for peginterferon alfa-2b 0.3 mL

  First Dose Reduction to Peginterferon alfa-2b
  1 mcg/kg 

  Second Dose Reduction to Peginterferon alfa-2b 0.5 mcg/kg

  Body weight    kg (lbs)

  Peginterferon alfa-2b Vial Strength to Use   

  Amount of Peginterferon    alfa-2b (mcg) to Administer

  Volume (mL)* of Peginterferon    alfa-2b to Administer

  Body weight    kg (lbs)

  Peginterferon alfa-2b Vial Strength to Use   

  Amount of Peginterferon    alfa-2b (mcg) to Administer

  Volume (mL)* of Peginterferon    alfa-2b to Administer

  <40
  (<88)

  50 mcg per 0.5 mL

  35

  0.35

  <40
  (<88)

  50 mcg per 0.5 mL†

  20

  0.2

  40–50
  (88–111)

  45

  0.45

  40–50
  (88–111)

  25

  0.25

  51–60
  (112–133)

  50

  0.5

  51–60
  (112–133)

  50 mcg per 0.5 mL

  30

  0.3

  61–75
  (134–166)

  80 mcg per 0.5 mL

  64

  0.4

  61–75
  (134–166)

  35

  0.35

  76–85
  (167–187)

  80

  0.5

  76–85
  (167–187)

  45

  0.45

  86–104
  (188–230)

  120 mcg per 0.5 mL

  96

  0.4

  86–104
  (188–230)

  50

  0.5

  105–125
  (231–275)

  108

  0.45

  105–125
  (231–275)

  80 mcg per 0.5 mL

  64

  0.4

  >125
  (>275)

  150 mcg per 0.5 mL

  135

  0.45

  >125
  (>275)

  72

  0.45

  Dose reduction in pediatric patients is accomplished by modifying the recommended peginterferon alfa-2b dose in a two-step process from the original starting dose of 60 mcg/m2/week, to 40 mcg/m2/week, then to 20 mcg/m2/week, if needed (see Table 5). In the pediatric combination therapy trial, dose reductions occurred in 25% of subjects receiving peginterferon alfa-2b 60 mcg/m2 weekly plus ribavirin 15 mg/kg daily. Dose reduction in pediatric patients is accomplished by modifying the recommended ribavirin dose from the original starting dose of 15 mg/kg daily in a two-step process to 12 mg/kg/day, then to 8 mg/kg/day, if needed (see Table 5).

  Ribavirin capsules should not be used in patients with creatinine clearance < 50 mL/min. Subjects with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)].

  Ribavirin capsules should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by ≥ 2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains < 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin capsules dose modified or discontinued per Table 5[see Warnings and Precautions (5.2)].

  Table 5: Guidelines for Dose Modification and Discontinuation of Peginterferon alfa-2b, Interferon alfa-2b or Peginterferon alfa-2b/Ribavirin Capsules Based on Laboratory Parameters in Adults and Pediatrics * For adult patients with a history of stable cardiac disease receiving peginterferon alfa-2b or interferon alfa-2b in combination with ribavirin, the peginterferon alfa-2b or interferon alfa-2b dose should be reduced by half and the ribavirin dose by 200 mg/day if a > 2 g/dL decrease in hemoglobin is observed during any 4-week period. Both peginterferon alfa-2b and ribavirin capsules or interferon alfa-2b and ribavirin capsules should be permanently discontinued if patients have hemoglobin levels < 12 g/dL after this ribavirin dose reduction. Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease ≥ 2 g/dL during any 4-week period during treatment should have weekly evaluations and hematology testing. † 1 st dose reduction of ribavirin is by 200 mg/day, except in patients receiving the 1400 mg dose it is by 400 mg/day; 2 nd dose reduction of ribavirin (if needed) is by an additional 200 mg/day. ‡ For patients on ribavirin/peginterferon alfa-2b combination therapy: 1 st dose reduction of peginterferon alfa-2b is to 1 mcg/kg/week, 2 nd dose reduction (if needed) of peginterferon alfa-2b is to 0.5 mcg/kg/week. For patients on ribavirin/interferon alfa-2b combination therapy, reduce interferon alfa-2b dose by 50%.

  Laboratory Values

  Adults

  Pediatrics

  Adults

  Pediatrics

  Peginterferon    alfa-2b
  /Interferon
  alfa-2b

  Peginterferon    alfa-2b

  Interferon alfa-2b

  Ribavirin capsules

  Hgb < 10g/dL

  For patients with cardiac disease, reduce by 50%*

  See footnote*

  See footnote*

  Adjust Dose†

  1st reduction to 12 mg/kg/day
  2nd reduction to 8 mg/kg/day

  WBC < 1.5 x 109/L
  Neutrophils < 0.75 x 109/L
  Platelets< 50 x 109/L (Adults)
  < 70 x 109/L (Pediatrics)

  Adjust Dose‡

  1st reduction to 40 mcg/m2/week
  2nd reduction to 20 mcg/m2/week

  Reduce by 50%

  No Dose Change

  No Dose Change

  Hgb < 8.5g/dL
  WBC < 1 x 109/L
  Neutrophils < 0.5 x 109/L
  Creatinine > 2 mg/dL (Pediatrics)   
  Platelets < 25 x 109/L (Adults)
  < 50 x 109/L (Pediatrics)

  Permanently Discontinue

  Permanently Discontinue

     Permanently    Discontinue

     Permanently    Discontinue

  Permanently Discontinue

  Refer to the Intron A Package Insert or PegIntron Powder for Injection Package Insert for additional information about how to reduce an interferon alfa-2b or peginterferon alfa-2b dose.

  2.5 Discontinuation of Dosing

  Adults

  It is recommended that HCV genotype 1 interferon-alfa-naïve patients receiving peginterferon alfa-2b in combination with ribavirin, be discontinued from therapy if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or whose HCV-RNA levels remain detectable (>10-20 IU/mL) after 24 weeks of therapy. Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

  Pediatrics (3-17 years of age)

  It is recommended that patients receiving peginterferon alfa-2b/ribavirin combination (excluding HCV Genotype 2 and 3) be discontinued from therapy at 12 weeks if their treatment Week 12 HCV-RNA dropped < 2 log10 compared to a pretreatment or at 24 weeks if they have detectable HCV-RNA (>10-20 IU/mL) at treatment Week 24.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Zolpidem Tartrate | Bryant Ranch Prepack

  

  ---

  The dose of zolpidem tartrate extended-release tablets, USP should be individualized.

  2.1 Dosage in Adults

  The recommended dose of zolpidem tartrate extended-release tablets for adults is 12.5 mg once daily immediately before bedtime. The total zolpidem tartrate extended-release tablets dose should not exceed 12.5 mg per day.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6 )].

  2.3 Use With CNS Depressants

  Dosage adjustments may be necessary when zolpidem tartrate extended-release tablet is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.5)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Torrent Pharmaceuticals Limited
  

  ×

  Zolpidem Tartrate | Torrent Pharmaceuticals Limited

  

  ---

  Initial Treatment

  Dosage for Adults

  Major Depressive Disorder and Obsessive-Compulsive Disorder–Sertraline hydrochloride treatment should be administered at a dose of 50 mg once daily.

  Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder–Sertraline hydrochloride treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.

  While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of sertraline hydrochloride for the treatment of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of sertraline hydrochloride, dose changes should not occur at intervals of less than 1 week.

  Premenstrual Dysphoric Disorder–Sertraline hydrochloride treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.

  While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50-150 mg/day with dose increases at the onset of each new menstrual cycle (see Clinical Trials under CLINICAL PHARMACOLOGY). Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.

  Sertraline hydrochloride should be administered once daily, either in the morning or evening.

  Dosage for Pediatric Population (Children and Adolescents)

  Obsessive-Compulsive Disorder–Sertraline hydrochloride treatment should be initiated with a dose of 25 mg once daily in children (ages 6-12) and at a dose of 50 mg once daily in adolescents (ages 13-17).

  While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25-200 mg/day in the clinical trials demonstrating the effectiveness of sertraline hydrochloride for pediatric patients (6-17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of sertraline hydrochloride, dose changes should not occur at intervals of less than 1 week.

  Sertraline hydrochloride should be administered once daily, either in the morning or evening.

  Maintenance/Continuation/Extended Treatment

  Major Depressive Disorder–It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline hydrochloride has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50-200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.

  Posttraumatic Stress Disorder–It is generally agreed that PTSD requires several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of sertraline hydrochloride has demonstrated that its efficacy in PTSD is maintained for periods of up to 28 weeks following 24 weeks of treatment at a dose of 50-200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.

  Social Anxiety Disorder–Social anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of sertraline hydrochloride has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50-200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.

  Obsessive-Compulsive Disorder and Panic Disorder–It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing sertraline hydrochloride for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking sertraline hydrochloride during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50-200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

  Premenstrual Dysphoric Disorder–The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. However, as women commonly report that symptoms worsen with age until relieved by the onset of menopause, it is reasonable to consider continuation of a responding patient. Dosage adjustments, which may include changes between dosage regimens (e.g., daily throughout the menstrual cycle versus during the luteal phase of the menstrual cycle), may be needed to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment.

  Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders: At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with sertraline hydrochloride. Conversely, at least 14 days should be allowed after stopping sertraline hydrochloride before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

  Use of Sertraline Hydrochloride With Other MAOIs Such as Linezolid or Methylene Blue: Do not start sertraline hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

  In some cases, a patient already receiving sertraline hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, sertraline hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with sertraline hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with sertraline hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

  Special Populations

  Dosage for Hepatically Impaired Patients–The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

  Treatment of Pregnant Women During the Third Trimester–Neonates exposed to sertraline hydrochloride and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with sertraline hydrochloride during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. 

  Discontinuation of Treatment with Sertraline Hydrochloride

  Symptoms associated with discontinuation of sertraline hydrochloride and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  Close
  No Recall

  More Info
• Tya Pharmaceuticals
  

  ×

  Zolpidem Tartrate | Tya Pharmaceuticals

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness . The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime. [see Warnings and Precautions (5.1)]

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].  

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects . [see Warnings and Precautions (5.1)]

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• A-s Medication Solutions Llc
  

  ×

  Zolpidem Tartrate | A-s Medication Solutions Llc

  

  ---

  The dose of zolpidem tartrate tablets should be individualized.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  2.1 Dosage in adults

  The recommended dose for adults is 10 mg once daily immediately before bedtime. The total zolpidem tartrate tablet dose should not exceed 10 mg per day.

  2.2 Special populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

  2.3 Use with CNS depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info
• Proficient Rx Lp
  

  ×

  Zolpidem Tartrate | Jubilant Cadista Pharmaceuticals, Inc.

  

  ---

  All dosing should be given in a twice-a-day regimen. Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets, USP may be interchanged at equal doses.

  Oxcarbazepine tablets, USP should be kept out of the reach and sight of children.

  Oxcarbazepine tablets, USP can be taken with or without food [see Clinical Pharmacology (12.3)].

  2.1 Adjunctive Therapy for Adults

  Treatment with oxcarbazepine tablets, USP should be initiated with a dose of 600 mg/day, given in a twice-a-day regimen. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of oxcarbazepine tablets, USP titration, as these plasma levels may be altered, especially at oxcarbazepine tablets, USP doses greater than 1200 mg/day [see Drug Interactions (7.1)].

  2.2 Conversion to Monotherapy for Adults

  Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets, USP at 600 mg/day (given in a twice-a-day regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs. The concomitant AEDs should be completely withdrawn over 3-6 weeks, while the maximum dose of oxcarbazepine tablets, USP should be reached in about 2-4 weeks. Oxcarbazepine tablets, USP may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxcarbazepine tablets, USP. Patients should be observed closely during this transition phase.

  2.3 Initiation of Monotherapy for Adults

  Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine tablets, USP. In these patients, oxcarbazepine tablets, USP should be initiated at a dose of 600 mg/day (given in a twice-a-day regimen); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. Controlled trials in these patients examined the effectiveness of a 1200 mg/day dose; a dose of 2400 mg/day has been shown to be effective in patients converted from other AEDs to oxcarbazepine tablets, USP monotherapy (see above).

  2.4 Adjunctive Therapy for Pediatric Patients (Aged 2-16 Years)

  In pediatric patients aged 4-16 years, treatment should be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. The target maintenance dose of oxcarbazepine tablets, USP should be achieved over two weeks, and is dependent upon patient weight, according to the following chart:

    20-29 kg - 900 mg/day   29.1-39 kg - 1200 mg/day   >39 kg - 1800 mg/day

  In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6-51 mg/kg.

  In pediatric patients aged 2 to <4 years, treatment should also be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a twice-a-day regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered [see Clinical Pharmacology (12.3)]. The maximum maintenance dose of oxcarbazepine tablets, USP should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day in a twice-a-day regimen.

  In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.

  Under adjunctive therapy (with and without enzyme-inducing AEDs), when normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to ≤12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.

  2.5 Conversion to Monotherapy for Pediatric Patients (Aged 4-16 Years)

  Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets, USP at approximately 8-10 mg/kg/day given in a twice-a-day regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3-6 weeks while oxcarbazepine tablets, USP may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase.

  The recommended total daily dose of oxcarbazepine tablets, USP is shown in the table below.

  2.6 Initiation of Monotherapy for Pediatric Patients (Aged 4-16 Years)

  Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine tablets, USP. In these patients, oxcarbazepine tablets, USP should be initiated at a dose of 8-10 mg/kg/day given in a twice-a-day regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.

  Table 1 Range of Maintenance Doses of Oxcarbazepine Tablets, USP for Children by Weight During Monotherapy From To Weight in kg Dose (mg/day) Dose (mg/day) 20 600 900 25 900 1200 30 900 1200 35 900 1500 40 900 1500 45 1200 1500 50 1200 1800 55 1200 1800 60 1200 2100 65 1200 2100 70 1500 2100 2.7 Patients with Hepatic Impairment

  In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment [see Clinical Pharmacology (12.3).]

  2.8 Patients with Renal Impairment

  In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response [see Clinical Pharmacology (12.3)]

  Close
  No Recall

  More Info
• Proficient Rx Lp
  

  ×

  Zolpidem Tartrate | Jiangmen Nowadays Daily Goods Co., Ltd.

  

  ---

  Self-dries in seconds. Leaves skin soft and smooth.

  Close
  No Recall

  More Info
• Kaiser Foundation Hospitals
  

  ×

  Zolpidem Tartrate | Mcure Health Solutions Inc.

  

  ---

  Directions

  Adults and Children 12 years of age and over:

  Clean and dry area of application. Peel off protective film and apply patch once or twice a day.

  Apply patch an hour after and before shower or bath. Patch will remain effective for 8 hours.

  Children under 12 years of age, consult a physician.

  Close
  No Recall

  More Info
• Proficient Rx Lp
  

  ×

  Zolpidem Tartrate | Safeway

  

  ---

  adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

  children under 2 years of age:

  • do not use. Ask a doctor.

  for external anal itching:

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • children under 12 years of age with external anal itching: ask a doctor

  Close
  No Recall

  More Info
• Directrx
  

  ×

  Zolpidem Tartrate | Directrx

  

  ---

  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].  

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

  2.4 Administration

  The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  Close
  No Recall

  More Info