temazepam, Restoril

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GENERIC NAME: temazepam

BRAND NAME: Restoril

DRUG CLASS AND MECHANISM: Temazepam is a drug that is used for treating anxiety. It is in the benzodiazepine class of drugs, the same family that includes diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), flurazepam (Dalmane), lorazepam (Ativan), and others. Temazepam and other benzodiazepines act by enhancing the effects of gamma- aminobutyric acid (GABA) in the brain. GABA is a neurotransmitter (a chemical messenger that nerve cells use to communicate with each other) that inhibits many of the activities of the brain. It is believed that excessive activity in the brain may lead to anxiety or other psychiatric disorders and that temazepam reduces the activity. Temazepam increases total sleep time. The FDA approved temazepam in February 1981.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes PREPARATIONS: Capsules: 7.5, 15, 22.5, and 30 mg

STORAGE: Capsules should be kept at room temperature, 20-25 C (68-77F).

PRESCRIBED FOR: Temazepam is used for the short-term (7-10 days) management of insomnia. Insomnia is defined as difficulty falling asleep, frequent awakening during the night after falling asleep, and/or early morning awakening.

DOSING: The recommended dose of temazepam is 7.5 to 30 mg taken about 30 minutes prior to bedtime. For elderly patients, start with 7.5 mg until the response is determined.

DRUG INTERACTIONS: Alcohol or drugs that cause sleepiness increase the effects of temazepam.

PREGNANCY: Temazepam and other benzodiazepines have been associated with fetal damage, including congenital malformations, when taken by pregnant women in their first trimester. Temazepam should be avoided during pregnancy.

 NURSING MOTHERS: Use by nursing mothers has not been adequately studied.

SIDE EFFECTS: The most common side effects associated with temazepam are excessive sleepiness, dizziness, weakness, and unsteadiness. Other side effects include a feeling of depression, loss of orientation, headache, and sleep disturbances. Like all benzodiazepines, temazepam can cause physical dependence. Suddenly stopping temazepam after a few months of daily use may be associated with a feeling of loss of self-worth, agitation, and insomnia. If temazepam is taken continuously for longer than a few months, stopping treatment suddenly may produce seizures, tremors, muscle cramping, vomiting, and/or sweating. Therefore, discontinuation usually is accomplished by slowly reducing the daily dose. There have been reports that people who have taken sedative hypnotics sleep-driving or performing other complex tasks and have no memory of the event. This may occur more often when temazepam is combined with alcohol or other drugs that affect the nervous system. Rare cases of severe allergic reactions involving swelling of the tongue and throat have been reported.

Reference: FDA Prescribing Information


Last Editorial Review: 1/4/2012




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