Restoril is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Temazepam affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Restoril is used to treat insomnia (trouble falling or staying asleep).

Restoril works by slowing down the central nervous system (brain), causing drowsiness which helps patients fall asleep.

Restoril can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

Never take Restoril if you do not have at least 7 to 8 hours to sleep before being active again.

Do not use Restoril if you are pregnant. Temazepam can cause birth defects or life-threatening withdrawal symptoms in a newborn. Use effective birth control to prevent pregnancy while taking this 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.

Temazepam may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be shared with another person, especially someone who has a history of drug abuse or addiction. MISUSE OF TEMAZEPAM CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Temazepam may cause a severe allergic reaction. Stop taking this medicine 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 this medication only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Take Restoril exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Restoril in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take this medicine only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Call your doctor if your insomnia does not improve after taking Restoril for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions.

Restoril should be used for only a short time. Do not take this medicine for longer than 2 weeks without your doctor's advice.

Do not stop using this medicine without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly.

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

Usual Adult Dose for Insomnia:

7.5 to 30 mg orally once a day at bedtime

Comments:
-In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency.
-In elderly or debilitated patients, therapy should be initiated at 7.5 mg until individual responses are determined.

Use: Short-term treatment of insomnia (generally 7 to 10 days)

You should not use Restoril if you are allergic to temazepam.

Do not use Restoril if you are pregnant or may become pregnant. This medicine could harm the unborn baby.

To make sure Restoril is safe for you, tell your doctor if you have ever had:

• lung disease or breathing problems;

• depression, mental illness, suicidal thoughts;

• alcoholism or drug addiction; or

• liver or kidney disease.

Ask a doctor if it is safe to breastfeed while using this medicine.

Restoril is not approved for use by anyone younger than 18 years old.

Restoril is used when needed. If you are on a dosing schedule, skip any missed dose. Take this medicine only when you have time for several hours of sleep. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of temazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include extreme drowsiness, confusion, or coma.

Do not drink alcohol. Dangerous side effects or death could occur.

You may still feel sleepy the morning after taking this medicine. Wait until you are fully awake before you drive, operate machinery, or do anything that requires you to be awake and alert. Your reactions may be impaired.

Temazepam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Restoril: hives; difficulty breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Restoril can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• confusion, agitation, hallucinations;

• depressed mood; or

• thoughts of suicide or hurting yourself.

Some people using Restoril have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common Restoril side effects may include:

• drowsiness, tiredness;

• dizziness;

• headache;

• nausea; or

• feeling nervous.

After you stop using Restoril, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking Restoril with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with temazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.