Restoril - Clinical information

Restoril™ (temazepam) capsules

Provide low-dose safety¹

Restoril™ (temazepam) capsules have an optimal pharmacologic design providing an enhanced safety profile. With a terminal half-life of 8.8 hours, your patients will receive a full night’s sleep from “the low-dose doze” without the effects of next-day hangover.

Since Restoril™ (temazepam) capsules are the only commonly prescribed sleep medication metabolized using conjugation (rather than oxidation), there are no cytochrome P450 drug interactions, which is especially important for patients taking multiple medications. Conjugative metabolism, mainly hepatic glucuronidation in the case of Restoril™ (temazepam), makes the drug highly water soluble, less prone to interactions, and allows it to be easily distributed and carried away. And, there are no active metabolites with Restoril™ (temazepam) so there is no drug buildup.

Clinical studies have shown essentially no anticholinergic (eg, dry mouth) or hangover side effects, no measurable effects on daytime alertness or performance, low potential for memory loss, rebound insomnia,² daytime anxiety, or abuse.³ And, there was no evidence of tolerance development (after at least 2 weeks of therapy).

Important safety information: Restoril™ is indicated for the short-term treatment of insomnia (generally 7 to 10 days). 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. Restoril™ is contraindicated in women who are pregnant or may become pregnant because of the potential risk to the fetus. The most common side effects of Restoril™ are drowsiness, dizziness, lightheadedness, and difficulty with coordination. Severe allergic reactions have been reported in patients taking sedative-hypnotics, including Restoril™. Complex behaviors such as “sleep driving” have also been reported. Although behaviors such as “sleep driving” may occur with Restoril™ alone at therapeutic doses, the use of alcohol or other CNS depressants with Restoril™ appears to increase the risk of these unusual behaviors, as does the use of Restoril™ doses exceeding the maximum recommended dose. Use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft.

Healthcare Provider Letter

For more information about Restoril™ (temazepam) capsules, please read the complete prescribing information.

References:
1. Restoril™ (temazepam) capsules complete prescribing information, Mallinckrodt Inc.
2. Lader MH. Insomnia and short-acting benzodiazepine hypnotics. J Clin Psychiatry. 1983;44:47-53.
3. Hardman JG, Limbird LE, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill; 1996:370.