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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.