Temazepam

Temazepam

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Questions & Answers

Side Effects & Adverse Reactions

Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. 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 may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior. Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class. Because some of the worrisome adverse effects of benzodiazepines, including temazepam capsules, appear to be dose related (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), it is important to use the lowest possible effective dose. Elderly patients are especially at risk.

Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol. Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization. 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 temazepam capsules alone at therapeutic doses, the use of alcohol and other CNS depressants with temazepam capsules appears to increase the risk of such behaviors, as does the use of temazepam capsules at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of temazepam capsules 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 neuro-psychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking 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.

Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE).

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 temazepam capsules. 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 temazepam capsules 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

Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days).

For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days).

The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

History

There is currently no drug history available for this drug.

Other Information

Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:

Temazepam Chemical Structure

Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol, USP.

Temazepam capsules, 15 mg and 30 mg, are for oral administration.

Active ingredient: temazepam, USP

Inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shells and imprinting inks contain: gelatin, iron oxide black, shellac, propylene glycol, titanium dioxide, methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate and edetate calcium disodium. The 15 mg capsules also contain D&C Yellow #10 and FD&C Blue #1.

Temazepam Manufacturers


  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Temazepam Capsule [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Proficient Rx Lp
    Temazepam Capsule [Proficient Rx Lp]
  • American Health Packaging
    Temazepam Capsule [American Health Packaging]
  • Major Pharmaceuticals
    Temazepam Capsule [Major Pharmaceuticals]
  • Proficient Rx Lp
    Temazepam Capsule [Proficient Rx Lp]
  • A-s Medication Solutions Llc
    Temazepam Capsule [A-s Medication Solutions Llc]
  • Kaiser Foundation Hospitals
    Temazepam Capsule [Kaiser Foundation Hospitals]
  • Rebel Distributors Corp
    Temazepam Capsule [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Temazepam Capsule [Rebel Distributors Corp]
  • Udl Laboratories, Inc.
    Temazepam Capsule [Udl Laboratories, Inc.]
  • Physicians Total Care, Inc.
    Temazepam Capsule [Physicians Total Care, Inc.]
  • Cardinal Health
    Temazepam Capsule [Cardinal Health]
  • Sandoz Inc
    Temazepam Capsule [Sandoz Inc]
  • Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc
    Temazepam Capsule [Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Temazepam Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Stat Rx Usa Llc
    Temazepam Capsule [Stat Rx Usa Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Temazepam Capsule [Pd-rx Pharmaceuticals, Inc.]
  • H.j. Harkins Company, Inc.
    Temazepam Capsule [H.j. Harkins Company, Inc.]
  • Novel Laboratories, Inc.
    Temazepam Capsule [Novel Laboratories, Inc.]
  • Stat Rx Usa Llc
    Temazepam Capsule [Stat Rx Usa Llc]
  • Mckesson Contract Packaging
    Temazepam Capsule [Mckesson Contract Packaging]
  • Bryant Ranch Prepack
    Temazepam Capsule [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Temazepam Capsule [Bryant Ranch Prepack]
  • Mylan Pharmaceuticals Inc.
    Temazepam Capsule [Mylan Pharmaceuticals Inc.]
  • Ascend Laboratories, Llc
    Temazepam Capsule [Ascend Laboratories, Llc]
  • Remedyrepack Inc.
    Temazepam Capsule [Remedyrepack Inc. ]
  • Unit Dose Services
    Temazepam Capsule [Unit Dose Services]
  • Unit Dose Services
    Temazepam Capsule [Unit Dose Services]
  • Unit Dose Services
    Temazepam Capsule [Unit Dose Services]
  • Aphena Pharma Solutions – Tennessee, Llc
    Temazepam Capsule [Aphena Pharma Solutions – Tennessee, Llc]
  • Aphena Pharma Solutions – Tennessee, Llc
    Temazepam Capsule [Aphena Pharma Solutions – Tennessee, Llc]
  • A-s Medication Solutions Llc
    Temazepam Capsule [A-s Medication Solutions Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Temazepam Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Actavis Elizabeth Llc
    Temazepam Capsule [Actavis Elizabeth Llc]
  • Preferred Pharmaceuticals, Inc
    Temazepam Capsule [Preferred Pharmaceuticals, Inc]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Temazepam Capsule [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Mallinckrodt, Inc.
    Temazepam Capsule [Mallinckrodt, Inc.]
  • American Health Packaging
    Temazepam Capsule [American Health Packaging]
  • Remedyrepack Inc.
    Temazepam Capsule [Remedyrepack Inc. ]
  • Direct Rx
    Temazepam Capsule [Direct Rx]
  • Direct Rx
    Temazepam Capsule [Direct Rx]
  • Aphena Pharma Solutions – Tennessee, Llc
    Temazepam Capsule [Aphena Pharma Solutions – Tennessee, Llc]
  • Golden State Medical Supply, Inc.
    Temazepam Capsule [Golden State Medical Supply, Inc.]
  • Kaiser Foundation Hospitals
    Temazepam Capsule [Kaiser Foundation Hospitals]
  • Cardinal Health
    Temazepam Capsule [Cardinal Health]
  • Aphena Pharma Solutions – Tennessee, Llc
    Temazepam Capsule [Aphena Pharma Solutions – Tennessee, Llc]
  • Cardinal Health
    Temazepam Capsule [Cardinal Health]
  • Mutual Pharmaceutical Company, Inc.
    Temazepam Capsule [Mutual Pharmaceutical Company, Inc.]
  • Proficient Rx Lp
    Temazepam Capsule [Proficient Rx Lp]
  • Avkare, Inc.
    Temazepam (Temazepam) Capsule [Avkare, Inc.]
  • Directrx
    Temazepam Capsule [Directrx]
  • Directrx
    Temazepam Capsule [Directrx]
  • Mckesson Packaging Services
    Temazepam Capsule [Mckesson Packaging Services]

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