Zzz Sleep
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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. 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 and ), it is important to use the lowest possible effective dose. Elderly patients are especially at risk. 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.PRECAUTIONSDOSAGE AND ADMINISTRATION
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
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 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.
Sources
Zzz Sleep Manufacturers
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Western Family Foods Inc
![Zzz Sleep (Diphenhydramine Hcl) Liquid [Western Family Foods Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zzz Sleep | Tya Pharmaceuticals
While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.
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Western Family Foods Inc
Zzz Sleep | Western Family Foods Inc
• take only one dose per day (24 hours) – see Overdose warning adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use Other information • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F) • protect from light
![Zzz Sleep (Diphenhydramine Hcl) Capsule, Liquid Filled [Western Family Foods Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7d1a7c9d-6652-4af1-ac55-2cc1e7d5fb88&name=8cb47378-ca23-483f-bd0f-80fdf1391e5f-01.jpg)
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