Brand Names: Restoril

Generic Name: temazepam (Pronunciation: te MAZ e pam)

• What is temazepam (Restoril)?
• What are the possible side effects of temazepam (Restoril)?
• What is the most important information I should know about temazepam (Restoril)?
• What should I discuss with my healthcare provider before taking temazepam (Restoril)?
• How should I take temazepam (Restoril)?
• What happens if I miss a dose (Restoril)?
• What happens if I overdose (Restoril)?
• What should I avoid while taking temazepam (Restoril)?
• What other drugs will affect temazepam (Restoril)?
• Where can I get more information?

What is temazepam (Restoril)?

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

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

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

Restoril 15 mg

peach/red, imprinted with RESTORIL 15 MG, FOR SLEEP

Restoril 30 mg

red/turquoise, imprinted with RESTORIL 30 mg, FOR SLEEP

Temazepam 15 mg-MYL

peach, imprinted with MYLAN 4010

Temazepam 30 mg-MYL

yellow, imprinted with MYLAN 5050

Temazepam 30 mg-PUR

white, imprinted with R-077

Temazepam 7.5 mg-GG

peach/white, imprinted with TEMAZEPAM 7.5 mg, 271 cp

What are the possible side effects of temazepam (Restoril)?

Temazepam may cause a severe allergic reaction. Stop taking temazepam 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 temazepam 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 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.

What is the most important information I should know about temazepam (Restoril)?

Temazepam may cause a severe allergic reaction. Stop taking temazepam 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 temazepam 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 temazepam 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 temazepam if you are pregnant.

Before taking temazepam, 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 temazepam. 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 temazepam.

Temazepam 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.