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Frequently Asked Questions

What is Restoril™ (temazepam)?
Restoril™ (temazepam) is a safe and effective prescription sleep medication indicated for short-term insomnia. Restoril™ (temazepam) is classified as a benzodiazepine hypnotic and comes in capsule form in four different doses: 7.5 mg, 15 mg, 22.5 mg, and 30 mg. The 7.5 mg dose was developed to provide patients with an option for taking the lowest effective dose of a sleep agent. The 22.5 mg dose was recently introduced as an intermediate titration option offering additional dosing flexibility.

How soon will I fall asleep?
After taking Restoril™ (temazepam), sleep typically occurs within 30 minutes. You should take Restoril™ (temazepam) when you are ready to go to sleep.

How long will I stay asleep?
After taking Restoril™ (temazepam), sleep typically lasts for 7 hours. You should be able to stay asleep and wake up refreshed without next-day grogginess.

How long can I take Restoril™ (temazepam)?
Generally, Restoril™ (temazepam) is prescribed for short-term use only (7-10 days). Some people have chronic sleep problems that may require more prolonged use of sleep medicine. However, you should not use these medicines for long periods without talking with your doctor about the risks and benefits of prolonged use.

Will Restoril™ (temazepam) help my sleep problems?
Restoril™ (temazepam) is a safe and effective treatment for short-term insomnia. However, before taking medication it is important to identify behavioral, psychological, or physical factors that may be contributing to your sleep problems. Keeping track of your sleep habits through the use of a sleep diary is one way to help your physician determine if medication is an appropriate treatment choice for you. Often, a combination of treatment approaches, including medication and behavioral change, is necessary to improve sleep. Sleep disorders typically do not improve without taking some action.

Are there any side effects?
Restoril™ (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. Reported side effects for Restoril™ (temazepam) capsules, as are common with other benzodiazepines, include the following: drowsiness, dizziness, lightheadedness, and difficulty with coordination. Call your doctor if you notice any untoward side effects.

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. Please read the Restoril™ (temazepam) capsules complete prescribing information for additional information.

Will I feel okay the next day?
Restoril™ (temazepam) studies show side effects were usually mild and of short duration. There is essentially no lingering drowsiness, no daytime performance issues, and low potential for memory loss or the return of insomnia (following drug discontinuation) associated with the use of Restoril™ (temazepam).

What makes Restoril™ (temazepam) different from other sleep medications?
Restoril™ (temazepam) has low potential for side effects. Unlike some other sleep medications, Restoril™ (temazepam) is broken down in the liver using a system that allows the drug to be easily distributed and carried away so there is less concern for drug interactions, which is especially important in elderly populations and patients taking multiple medications.

Can I take Restoril™ (temazepam) if I’m also taking other medications?
Generally, Restoril™ (temazepam) does not interfere with other medications, but you should always consult your physician or pharmacists about the possibility of drug interactions. Restoril™ (temazepam) capsules are not to be taken with alcohol or any other CNS depressants.

Can I take Restoril™ (temazepam) if I am pregnant or nursing?
No. Restoril™ (temazepam) capsules are prohibited for use during pregnancy because of potential risk to the fetus. Precautions should be observed for patients who are nursing and those with impaired renal or hepatic function or chronic pulmonary insufficiency.

Can Restoril™ (temazepam) be used in the elderly patient population?
Yes. Restoril™ (temazepam) can be safely used in most patient populations. In fact, clinical trials showed that early morning awakening, a particular problem in elderly patients, was significantly reduced with Restoril™ (temazepam) use. Restoril™ (temazepam) capsules are ideally suited for elderly patients since the medication is broken down in the liver using a system that allows the drug to be easily distributed and carried away so there is less concern for drug interactions. Plus, with the 7.5 mg dose, patients can feel confident about receiving the lowest effective dose for a full night’s sleep.

How can I use Restoril™ (temazepam) safely?
To ensure the safe and effective use of Restoril™ (temazepam) capsules or any other benzodiazepine sleeping medicine, you should observe the following cautions:

  1. Restoril™ (temazepam) is a prescription medicine and should be used ONLY as directed by your doctor. Follow your doctor’s instructions about how to take, when to take, and how long to take Restoril™ (temazepam).
  2. Never use Restoril™ (temazepam) or any other benzodiazepine sleeping medicine for longer than 1 or 2 weeks without first asking your doctor.
  3. If you notice any unusual or disturbing thoughts or behavior during treatment, contact your doctor.
  4. Tell your doctor about any medicines you may be taking, including medicines you may buy without a prescription. You should also tell your doctor if you drink alcohol. DO NOT use alcohol while taking Restoril™ (temazepam) capsules or any other benzodiazepine sleeping medicine.
  5. Do not take Restoril™ (temazepam) capsules or any other benzodiazepine sleeping medicine unless you are able to get a full night’s sleep before you must be active again.
  6. Do not increase the prescribed dose of Restoril™ (temazepam) capsules or any other benzodiazepine sleeping medicine unless instructed by your doctor.
  7. Use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft when you first start taking Restoril™ (temazepam) until you know whether there is any carryover effect the next day.
  8. Be aware that you may have more sleeping problems (rebound insomnia) the first night or two after stopping Restoril™ (temazepam) capsules or any other benzodiazepine sleeping medicine.
  9. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking Restoril™ (temazepam). Restoril™ (temazepam) capsules or any other benzodiazepine sleeping medicine should not be taken at any time during pregnancy.
  10. As with all prescription medicines, never share Restoril™ (temazepam) capsules or any other benzodiazepine sleeping medicine with anyone else. Always store Restoril™ (temazepam) in the original container out of the reach of children.
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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.

Reference:
Restoril™ (temazepam) capsules complete prescribing information, Mallinckrodt Inc.