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Restoril belongs to a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). It affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Restoril is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Restoril may also be used for other purposes not listed in this medication guide.

Important information

Restoril may cause a severe allergic reaction. Stop taking it and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take Restoril only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Restoril and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to temazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or triazolam (Halcion). This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use Restoril if you are pregnant.

Before taking Restoril, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, myasthenia gravis, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking Restoril. It can increase some of the side effects, and could possibly cause a fatal overdose.

Avoid using other medicines that make you sleepy. They can add to sleepiness caused by Restoril.

Restoril may be habit-forming and should be used only by the person it was prescribed for. Temazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before taking this medicine

Some people using Restoril have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Restoril and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to temazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or triazolam (Halcion).

Before taking Restoril, tell your doctor if you are allergic to any drugs, or if you have:

  • asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;

  • glaucoma;

  • kidney or liver disease;

  • myasthenia gravis;

  • a history of depression or suicidal thoughts or behavior; or

  • a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Restoril.

Restoril can cause birth defects in an unborn baby. It may also cause addiction or withdrawal symptoms in a newborn if the mother takes Restoril late in pregnancy. Do not use temazepam if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of Restoril may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking Restoril.

Do not give this medication to anyone under 18 years old.

How should I take Restoril?

Take Restoril exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Restoril only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine. Contact your doctor if this medicine seems to stop working as well in helping you fall asleep and stay asleep. Restoril should be used for only a short time to treat insomnia. After 7 to 10 nights of use, talk with your doctor about whether or not you should keep taking Restoril.

Your insomnia symptoms may return when you stop using Restoril after using it over a long period of time. You may need to use less and less before you stop the medication completely.

Restoril may be habit-forming and should be used only by the person it was prescribed for. Temazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Store this medication at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since Restoril is taken as needed, you are not likely to be on a dosing schedule. Take this medicine only when you have time for several hours of sleep.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Restoril can be fatal, especially if taken with alcohol.

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, slurred speech, tremors, a slow heartbeat, shallow breathing, feeling light-headed, fainting, seizure (black-out or convulsions), and coma.

What should I avoid?

Do not drink alcohol while you are taking Restoril. It can increase some of the side effects, and could possibly cause a fatal overdose. Restoril can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Restoril side effects

Restoril may cause a severe allergic reaction. Stop taking Restoril and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Restoril and call your doctor at once if you have any of these serious side effects:
  • weak or shallow breathing;

  • fast or pounding heartbeats;

  • confusion, slurred speech, unusual thoughts or behavior;

  • hallucinations, agitation, aggression;

  • thoughts of suicide or hurting yourself;

  • restless muscle movements in your eyes, tongue, jaw, or neck;

  • pale skin, easy bruising or bleeding, unusual weakness;

  • fever, chills, body aches, flu symptoms;

  • problems with urination; or

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Restoril side effects may include:

  • daytime drowsiness (or during hours when you are not normally sleeping);

  • amnesia or forgetfulness;

  • muscle weakness, lack of balance or coordination;

  • numbness, burning, pain, or tingly feeling;

  • headache, blurred vision, depressed mood;

  • feeling nervous, excited, or irritable;

  • nausea, vomiting, stomach discomfort; or

  • dry mouth, increased thirst.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Restoril?

Before using Restoril, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Restoril.

Before taking this medicine, tell your doctor if you are using any of the following drugs:

  • fluvoxamine (Luvox);

  • itraconazole (Sporanox);

  • ketoconazole (Nizoral); or

  • nefazodone (Serzone).

This list is not complete and there may be other drugs that can interact with Restoril. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.


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