Introduction

Your doctor has prescribed Restoril® (temazepam) to help you sleep. The following information is intended to guide you in the safe use of this medicine. It is not meant to take the place of your doctor's instructions. If you have any questions about Restoril® (temazepam) capsules be sure to ask your doctor or pharmacist. Restoril® (temazepam) is used to treat different types of sleep problems, such as:

• trouble falling asleep
• waking up too early in the morning
• waking up often during the night Some people may have more than one of these problems.

Restoril® (temazepam) belongs to a group of medicines known as the “benzodiazepines.'' There are many different benzodiazepine medicines used to help people sleep better. Sleep problems are usually temporary, requiring treatment for only a short time, usually 7-10 days. However, if your sleep problems continue, consult your doctor. He/she will determine whether other measures are needed to overcome your sleep problems. 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.

SIDE EFFECTS

Common Side Effects

All medicines have side effects. The most common side effects of benzodiazepine sleeping medicines include:

• drowsiness
• dizziness
• lightheadedness
• difficulty with coordination

You may find that these medicines make you sleepy during the day. How drowsy you feel depends upon how your body reacts to the medicine, which benzodiazepine sleeping medicine you are taking, and how large a dose your doctor has prescribed. Day-time drowsiness is best avoided by taking the lowest dose possible that will still help you to sleep at night. Your doctor will work with you to find the dose of Restoril® (temazepam) that is best for you. To manage these side effects while you are taking this medicine:

• Use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft. As with any medicines used to help people sleep better, you should be very careful when you first start taking Restoril® (temazepam) until you know how the medicine will affect you.
• NEVER drink alcohol while you are being treated with Restoril® (temazepam) or any benzodiazepine medicine. Alcohol can increase the side effects of Restoril® (temazepam) or any other benzodiazepine medicine.
• Do not take any other medicines without asking your doctor first. This includes medicines you can buy without a prescription. Some medicines can cause drowsiness and are best avoided while taking Restoril® (temazepam).
• Always take the exact dose of Restoril® (temazepam) prescribed by your doctor. Never change your dose without talking to your doctor first.

SPECIAL CONCERNS

There are some special problems that may occur while taking benzodiazepine sleeping medicines.

Memory Problems

Benzodiazepine sleeping medicines may cause a special type of memory loss or “amnesia''. When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine. Memory loss can be a problem, however, when sleeping medicines are taken while traveling, such as during an airplane flight and the person wakes up before the effect of the medicine is gone. This has been called “traveler's amnesia''.

Memory problems were noticed in fewer than 1 in 100 patients taking Restoril® (temazepam) in clinical trials. Memory problems can be avoided if you take Restoril® (temazepam) only when you are able to get a full night's sleep (7-8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.

Tolerance

When benzodiazepine sleeping medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as “tolerance''. If tolerance to the medicine develops, other effects may occur depending upon which benzodiazepine sleeping medicine you are taking. Tolerance to benzodiazepine sleeping medicines that are shorter-acting may cause you to:

• wake up during the last third of the night
• become anxious or nervous while you are awake

These effects are less common with Restoril® (temazepam) because it is intermediate-acting.

Dependence

All the benzodiazepine sleeping medicines can cause dependence, especially when these medicines are used regularly for longer than a few weeks or at high doses. Some people develop a need to continue taking their medicines. This is known as dependence or “addiction.'' When people develop dependence, they may have difficulty stopping the benzodiazepine sleeping medicine. If the medicine is suddenly stopped, the body is not able to function normally and unpleasant symptoms may occur (See Withdrawal). They may find they have to keep taking the medicine either at the prescribed dose or at increasing doses just to avoid withdrawal symptoms. All people taking benzodiazepine sleeping medicines have some risk of becoming dependent on the medicine. However, people who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming addicted to benzodiazepine medicines. This possibility must be considered before using these medicines for more than a few weeks. If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting Restoril® (temazepam) or any benzodiazepine sleeping medicine.

Withdrawal

Withdrawal symptoms may occur when a benzodiazepine sleeping medicine is stopped suddenly after being used daily for a long time. But these symptoms can occur even if the medicine has been used for only a week or two.

In mild cases, withdrawal symptoms may include unpleasant feelings. In more severe cases, abdominal and muscle cramps, vomiting, sweating, shakiness, and rarely, seizures may occur. These more severe withdrawal symptoms are very uncommon.

Another problem that may occur when benzodiazepine sleeping medicines are stopped is known as “rebound insomnia''. This means that a person may have more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. If you should experience rebound insomnia, do not get discouraged. This problem usually goes away on its own after 1 or 2 nights. If you have been taking Restoril® (temazepam) or any other benzodiazepine sleeping medicine for more than 1 or 2 weeks, do not stop taking it on your own. Your doctor may give you special directions on how to gradually decrease your dose before stopping the medicine. Always follow your doctor's directions.

Changes in Behavior and Thinking

Some people using benzodiazepine sleeping medicines have experienced unusual changes in their thinking and/or behavior, including: more outgoing or aggressive behavior than normal; loss of personal identity; confusion; strange behavior; agitation; hallucinations; worsening of depression; and suicidal thoughts.

How often these effects occur depends on several factors, such as a person's general health or the use of other medicines. Clinical studies with Restoril® (temazepam) revealed that unusual behavior changes occurred in less than 1 in 100 patients.

It is also important to realize that it is rarely clear whether these behavior changes are caused by the medicine, an illness, or occur on their own. In fact, sleep problems that do not improve may be due to illnesses that were present before the medicine was used. If you or your family notice any changes in your behavior, or if you have any unusual or disturbing thoughts, call your doctor immediately.

Pregnancy

Certain benzodiazepines have been linked to birth defects when taken by a pregnant woman in the early months of pregnancy. These medicines can also cause sedation of the unborn baby when used during the last weeks of pregnancy.

Restoril® (temazepam) should not be taken at any time during pregnancy. 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).

SAFE USE OF BENZODIAZEPINE SLEEPING MEDICINES

To ensure the safe and effective use of Restoril® (temazepam) 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 with Restoril® (temazepam) or any other benzodiazepine sleeping medicine, 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) or any other benzodiazepine sleeping medicine.
5. Do not take Restoril® (temazepam) or any other benzodiazepine sleeping medicine unless you are able to get a full night's sleep before you must be active again. For example, Restoril® (temazepam) or any other benzodiazepine sleeping medicine should not be taken on an overnight airplane flight of less than 7-8 hours since “traveler's amnesia'' may occur.
6. Do not increase the prescribed dose of Restoril® (temazepam) 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) or any other benzodiazepine sleeping medicine until you know whether the medicine will still have some carryover effect in you the next day.
8. Be aware that you may have more sleeping problems (rebound insomnia) the first night or two after stopping Restoril® (temazepam) 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) 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) or any other benzodiazepine sleeping medicine with anyone else. Always store Restoril® (temazepam) or any other benzodiazepine sleeping medicine in the original container out of reach of children.

M and Restoril are registered trademarks of Mallinckrodt Inc.
*Romazicon is the registered trademark of Roche Laboratories.
**Trademark of Medical Economics Company, Inc.

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