Generic name: temazepam (te MAZ e pam)
Brand name: Restoril
Dosage form: capsule (15mg; 22.5mg; 30mg; 7.5mg)
Drug class: Benzodiazepines
Restoril (temazepam) 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.
Warnings
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.
Before taking this medicine
You should not use Restoril if you are allergic to temazepam or similar medicines (such as alprazolam, diazepam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Valium, Versed, Xanax, and others).
Do not use Restoril if you are pregnant. It could harm the unborn baby.
If you use temazepam while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
To make sure this medicine 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.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Restoril is not approved for use by anyone younger than 18 years old.
How should I take Restoril?
Take Restoril exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use temazepam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of temazepam.
Never share Restoril 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.
Do not stop using Restoril suddenly or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Dosing information
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)
What happens if I miss a dose?
Since Restoril is used when needed, you may not be on a dosing schedule. Take this medicine only when you have time for several hours of sleep. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include extreme drowsiness, confusion, or coma.
What to avoid
Do not drink alcohol. Dangerous side effects or death could occur.
You may still feel sleepy the morning after taking Restoril. 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.
Restoril side effects
Temazepam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: 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, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.
Call your doctor at once if you have:
- confusion, agitation, hallucinations;
- depressed mood; or
- thoughts of suicide or hurting yourself.
Some people using temazepam have engaged in activity such as driving, eating, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.
The sedative effects of temazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines.
Common Restoril side effects may include:
- day-time drowsiness or "hangover" feeling;
- headache;
- dizziness, tiredness;
- nausea; or
- feeling nervous.
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.
What other drugs will affect Restoril?
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 your current medicines and any medicine you start or stop using.