Zaleplon
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Questions & Answers
Side Effects & Adverse Reactions
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zaleplon. Because some of the important adverse effects of zaleplon appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly (see DOSAGEANDADMINISTRATION).
A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization.
Abnormal Thinking and Behavioral Changes
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative/hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with zaleplon alone at therapeutic doses, the use of alcohol and other CNS depressants with zaleplon appears to increase the risk of such behaviors, as does the use of zaleplon at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of zaleplon should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative/hypnotic. As with sleep-driving, patients usually do not remember these events. Amnesia and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative/hypnotics.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Following rapid dose decrease or abrupt discontinuation of the use of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs (see DRUGABUSEANDDEPENDENCE).
Zaleplon, like other hypnotics, has CNS-depressant effects. Because of the rapid onset of action, zaleplon should only be ingested immediately prior to going to bed or after the patient has gone to bed and has experienced difficulty falling asleep. Patients receiving zaleplon should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination (e.g., operating machinery or driving a motor vehicle) after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of zaleplon. Zaleplon, as well as other hypnotics, may produce additive CNS-depressant effects when coadministered with other psychotropic medications, anticonvulsants, antihistamines, ethanol, and other drugs that themselves produce CNS depression. Zaleplon should not be taken with alcohol. Dosage adjustment may be necessary when zaleplon is administered with other CNS-depressant agents because of the potentially additive effects.
Severe Anaphylactic and Anaphylactoid Reactions
Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the drug.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Zaleplon Capsules USP are indicated for the short-term treatment of insomnia. Zaleplon Capsules USP have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICALPHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
History
There is currently no drug history available for this drug.
Other Information
Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its molecular formula is C17H15N5O, and its molecular weight is 305.34. The structural formula is shown below.
Zaleplon is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC=1.23) over the pH range of 1 to 7.
Zaleplon Capsules USP contain zaleplon as the active ingredient. Inactive ingredients consist of colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C yellow #6 (10 mg capsule shell only), gelatin, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, starch, and titanium dioxide.
Sources
Zaleplon Manufacturers
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A-s Medication Solutions Llc
![Zaleplon Capsule [A-s Medication Solutions Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zaleplon | A-s Medication Solutions Llc
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see Pharmacokinetics under CLINICALPHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic Insufficiency
Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal Insufficiency
No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactionsunder PRECAUTIONS).
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Rebel Distributors Corp.
Zaleplon | Rebel Distributors Corp.
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS.). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Unichem Pharmaceuticals (Usa), Inc.
Zaleplon | Unichem Pharmaceuticals (usa), Inc.
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Ascend Laboratories, Llc
Zaleplon | Ascend Laboratories, Llc
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS). -
H.j. Harkins Company, Inc.
Zaleplon | H.j. Harkins Company, Inc.
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS). -
St Marys Medical Park Pharmacy
Zaleplon | St Marys Medical Park Pharmacy
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS). -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Zaleplon | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS.). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Pd-rx Pharmaceuticals, Inc.
Zaleplon | Pd-rx Pharmaceuticals, Inc.
The dose of zaleplon capsules should be individualized. The recommended dose of zaleplon capsules for most non-elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon capsules appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon capsules should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon capsules with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic InsufficiencyPatients with mild to moderate hepatic impairment should be treated with zaleplon capsules 5 mg because clearance is reduced in this population. Zaleplon capsules are not recommended for use in patients with severe hepatic impairment.
Renal InsufficiencyNo dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon capsules have not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see PRECAUTIONS: Drug Interactions).
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Rebel Distributors Corp
Zaleplon | Rebel Distributors Corp
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Rebel Distributors Corp
Zaleplon | Rebel Distributors Corp
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
-
Rebel Distributors Corp
Zaleplon | Rebel Distributors Corp
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Physicians Total Care, Inc.
Zaleplon | Physicians Total Care, Inc.
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY). Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended. Hepatic insufficiency
Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment. Renal insufficiency
No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS). -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Zaleplon | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Bryant Ranch Prepack
Zaleplon | Bryant Ranch Prepack
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS.). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Bryant Ranch Prepack
Zaleplon | Bryant Ranch Prepack
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Unit Dose Services
Zaleplon | Unit Dose Services
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most non-elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see ). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see , ). PRECAUTIONSCLINICAL PHARMACOLOGYPharmacokinetics
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiencyPatients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiencyNo dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see , ). PRECAUTIONSDrug Interactions
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A-s Medication Solutions Llc
Zaleplon | A-s Medication Solutions Llc
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most non-elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiencyPatients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiencyNo dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see PRECAUTIONS, Drug Interactions).
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Aurobindo Pharma Limited
Zaleplon | Amneal Pharmaceuticals Of New York, Llc
Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid, USP given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.
The usual therapeutic dosage in adults and children (regard less of age) is up to 1 mg daily. Resistant cases may require larger doses.
When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.
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Teva Pharmaceuticals Usa Inc
Zaleplon | Teva Pharmaceuticals Usa Inc
The dose of zaleplon capsules should be individualized. The recommended dose of zaleplon capsules for most non-elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon capsules appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon capsules should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon capsules with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon capsules on sleep latency (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon capsules. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiencyPatients with mild to moderate hepatic impairment should be treated with zaleplon capsules 5 mg because clearance is reduced in this population. Zaleplon capsules are not recommended for use in patients with severe hepatic impairment.
Renal insufficiencyNo dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon capsules have not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see PRECAUTIONS, Drug Interactions).
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Northstar Rx Llc
Zaleplon | Torrent Pharmaceuticals Limited
2.1 Dosage in AdultsUse 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 PopulationsElderly 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 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 (5.1)].
2.4 AdministrationThe effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.
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Dispensing Solutions, Inc.
Zaleplon | Dispensing Solutions, Inc.
The dose of zaleplon capsules should be individualized. The recommended dose of zaleplon capsules for most non-elderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon capsules appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon capsules should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon capsules with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon capsules on sleep latency (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon capsules. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiencyPatients with mild to moderate hepatic impairment should be treated with zaleplon capsules 5 mg because clearance is reduced in this population. Zaleplon capsules is not recommended for use in patients with severe hepatic impairment.
Renal insufficiencyNo dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon capsules has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see PRECAUTIONS, Drug Interactions).
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Mylan Pharmaceuticals Inc.
Zaleplon | Sterling Knight Pharmaceuticals,llc
Clean and dry affected area, cut open pouch and remove patch, remove protective film and apply directly to area of pain, apply to affected area not more than 3 times daily, wash hands with soap after applying patch, reseal pouch containing unused patches. Use only one patch at a time, and maximum of three patches / day. Children under 12 should consult physician prior to use.
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Roxane Laboratories, Inc
Zaleplon | Roxane Laboratories, Inc
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see Pharmacokinetics under CLINICALPHARMACOLOGY).
Special Populations
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic Insufficiency
Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal Insufficiency
No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactionsunder PRECAUTIONS).
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Aidarex Pharmaceuticals Llc
Zaleplon | Aidarex Pharmaceuticals Llc
The dose of Zaleplon should be individualized. The recommended dose of Zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiency: Patients with mild to moderate hepatic impairment should be treated with Zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Pd-rx Pharmaceuticals, Inc.
Zaleplon | Pd-rx Pharmaceuticals, Inc.
Special Populations
The dose of zaleplon should be individualized. The recommended dose of zaleplon for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking zaleplon with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of zaleplon on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Hepatic insufficiency
Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Renal insufficiency
Patients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
No dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS). -
Upsher-smith Laboratories, Inc.
Zaleplon | Upsher-smith Laboratories, Inc.
The dose of Zaleplon Capsules should be individualized. The recommended dose of Zaleplon Capsules for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Zaleplon Capsules appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.
Zaleplon Capsules should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep (see PRECAUTIONS). Taking Zaleplon Capsules with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Zaleplon Capsules on sleep latency (see Pharmacokinetics under CLINICAL PHARMACOLOGY).
Special PopulationsElderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of zaleplon. The recommended dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.
Hepatic insufficiencyPatients with mild to moderate hepatic impairment should be treated with zaleplon 5 mg because clearance is reduced in this population. Zaleplon is not recommended for use in patients with severe hepatic impairment.
Renal insufficiencyNo dose adjustment is necessary in patients with mild to moderate renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment.
An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population (see Drug Interactions under PRECAUTIONS).
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Direct Rx
Zaleplon | Iroko Pharmaceuticals, Llc
Carefully consider the potential benefits and risks of Suppositories INDOCIN and other treatment options before deciding to use Suppositories INDOCIN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Suppositories INDOCIN, the dose and frequency should be adjusted to suit an individual patient’s needs.
Suppositories INDOCIN are available as 50 mg suppositories for rectal use. THIS SECTION MAKES REFERENCE TO CAPSULE DOSAGE FOR GUIDANCE IN USING SUPPOSITORIES.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.Pediatric Use
Suppositories INDOCIN ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).Adult Use
Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG. In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily. If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY. If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued. Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendonitis).
Initial Dose: 75-150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7-14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
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