FDA Approves Sandoz's Restoril

Restoril is a sleeping aid used in the short-term treatment of insomnia, a condition in which patients have difficulty falling asleep or staying asleep throughout the night.

Restoril belongs to a class of drugs known as benzodiazepines, which work by enhancing the activity of gamma-amino butyric acid (GABA), a neurotransmitter in the brain that produces sedative and calming effects.

Due to its potential for abuse, dependence and serious side effects, Restoril is a Schedule IV controlled substance under the U.S. Controlled Substances Act.

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.

Temazepam is a drug that is used for treating anxiety. It is in the benzodiazepine class of drugs, the same family that includes diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), flurazepam (Dalmane), lorazepam (Ativan), and others. Temazepam and other benzodiazepines act by enhancing the effects of gamma- aminobutyric acid (GABA) in the brain. GABA is a neurotransmitter (a chemical messenger that nerve cells use to communicate with each other) that inhibits many of the activities of the brain. It is believed that excessive activity in the brain may lead to anxiety or other psychiatric disorders and that temazepam reduces the activity. Temazepam increases total sleep time.

This medication is used for the short-term treatment of patients with trouble sleeping (insomnia). It is generally used for 7-10 days. It may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer period of time. Temazepam belongs to a class of medications called sedative/hypnotics. It acts on your brain to produce a calming effect.