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Side Effects and Safety Profile¹Restoril™ (temazepam) has low potential for abuse or side effects and has been successfully prescribed for over 2 decades. However, as with all medications, patients may experience some side effects. During controlled clinical studies in which 1076 patients received Restoril™ (temazepam) at bedtime, side effects were usually mild and of short duration. Reported concerns for Restoril™ (temazepam) capsules, as are common with other benzodiazepines, include the following: drowsiness, dizziness, lightheadedness, and difficulty with coordination. With Restoril™ (temazepam) there is little evidence of next-day grogginess (hangover effect) or the return of insomnia² (rebound insomnia) after the medication is stopped. There was no evidence of tolerance development in the sleep laboratory parameters when patients were given Restoril™ (temazepam) nightly for at least 2 weeks. Restoril™ (temazepam) capsules are not to be taken with alcohol or other CNS depressants; until it is known whether there is any carryover effect the next day, patients should exercise caution while doing anything that requires complete alertness, including operating a car, aircraft, or machinery. Unlike other sleep medications, Restoril™ (temazepam) is broken down in the liver using a system that allows the drug to be carried away so there is less concern for drug interactions, which is especially important in elderly populations and patients taking multiple medications. |
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Restoril™ is a registered trademark of Mallinckrodt Inc.
©2008 Mallinckrodt Pharmaceuticals. All Rights Reserved. Website Development by Strategic eCommerce Solutions. 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. For more information about Restoril™ (temazepam) capsules, please read the complete prescribing information. References: |
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