Restoril

Restoril is used for:

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Treating insomnia (trouble sleeping).

Restoril is a benzodiazepine. It works by depressing the central nervous system (brain), causing drowsiness to aid in falling asleep.

Do NOT use Restoril if:

• you are allergic to any ingredient in Restoril
• you are pregnant
• you have a severe mental disorder, acute angle-closure glaucoma, or severe liver disease
• you are taking clozapine or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Restoril :

Some medical conditions may interact with Restoril . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have or have ever had alcoholism or substance abuse or dependence, or if you drink more than 3 alcohol containing drinks per day
• if you have depression or have ever considered or attempted suicide
• if you have myasthenia gravis (a condition in which the muscles become progressively paralyzed)
• if you have angle-closure glaucoma, liver problems, or the blood disease porphyria
• if you have chronic bronchitis, chronic obstructive pulmonary disease, emphysema, or other breathing problems

Some MEDICINES MAY INTERACT with Restoril . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Clozapine because dangerous side effects, such as confusion; sedation; excess salivation; unsteady movements; lightheadedness, especially upon standing, difficult or slow breathing; or drowsiness leading to unresponsiveness or coma may occur
• Sodium oxybate (GHB) because an increase in sleep duration and decrease in the ability to breathe are likely to occur
• Disulfiram, kava, or valproic acid because they may increase the risk of Restoril 's side effects
• Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Restoril ; also they may decrease Restoril 's effectiveness
• Digoxin because the risk of its side effects may be increased by Restoril
• Nondepolarizing muscle relaxants (eg, tubocurarine) because actions and side effects may be increased, decreased, or unchanged by Restoril

This may not be a complete list of all interactions that may occur. Ask your health care provider if Restoril may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Restoril :

Use Restoril as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Restoril by mouth with or without food.
• Take 15 to 30 minutes before bedtime.
• If you miss a dose of Restoril , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Restoril .

Important safety information:

• Restoril may cause drowsiness, dizziness, lightheadedness, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Restoril with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Restoril ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• This medication can cause memory loss. Take this medication only when you are able to get a full night's sleep (7 to 8 hours). Be sure to talk with your doctor if you are experiencing memory problems.
• Some patients taking Restoril have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Restoril . It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Restoril . Tell your doctor right away if such an event happens to you.
• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.
• If you notice any unusual or disturbing thoughts or behavior while taking Restoril , contact your doctor at once.
• Use Restoril with caution in the ELDERLY; they may be more sensitive to its effects, especially oversedation, dizziness, or confusion.
• Restoril should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Restoril if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Restoril is found in breast milk. If you are or will be breast-feeding while you use Restoril , check with your doctor. Discuss any possible risks to your baby.

When sleep 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. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Restoril . This is known as DEPENDENCE or addiction.

If you stop taking Restoril suddenly, you may have WITHDRAWAL symptoms. This may include unpleasant feelings. In more severe cases, you may have stomach and muscle cramps, vomiting, sweating, and shakiness. Seizures may rarely occur. Another problem that may occur is "rebound insomnia," that is, more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. This usually goes away after 1 or 2 nights. If you take Restoril for more than 1 to 2 weeks, do not stop taking it without talking to your doctor.

Possible side effects of Restoril :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; clumsiness or unsteadiness; daytime drowsiness; dizziness; fatigue; feeling of hangover; headache; lightheadedness; nausea; nervousness; sluggishness; unusual weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include clumsiness; coma; confusion; difficult or slow breathing; dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness especially upon standing; loss of consciousness.

Store Restoril below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Restoril out of the reach of children and away from pets.

General information:

• If you have any questions about Restoril , please talk with your doctor, pharmacist, or other health care provider.
• Restoril is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Restoril . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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