Restoril™ (temazepam) Capsules USP, CIV 7.5 mg

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

• Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
• Behavioral changes may occur with use including aggressiveness and extroversion, bizarre behavior, agitation, hallucinations, and depersonalization.
• Risk of the development of oversedation, dizziness, confusion, and/or ataxia increases substantially with larger doses of benzodiazepines in elderly and debilitated patients, 7.5 mg of Restoril capsules are recommended as the initial dosage for such patients.
• Complex behaviors, such as sleep-driving, sleep-walking, etc. may occur with Restoril capsules alone at therapeutic doses, the use of alcohol and other CNS depressants with Restoril capsules appear to increase the risk of such behaviors, as does the use of Restoril capsules at doses exceeding the maximum recommended dose.
• Withdrawal symptoms have occurred after the abrupt discontinuation of benzodiazepines.
• Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Restoril capsules.
• Restoril capsules should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression.
• Additive effects can occur when Restoril is combined with other drugs having known hypnotic properties or CNS-depressant effects.
• Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines.

ADVERSE REACTIONS

• Serious adverse reactions include complex behaviors (e.g. sleep-driving, aggressiveness) and angioedema involving the tongue, glottis or larynx, hallucinations, and agitation.
• Common adverse reactions include drowsiness and headache.

USE IN SPECIFIC POPULATIONS

• Pregnancy category X. Contraindicated in pregnancy.
• Safety and effectiveness in pediatric patients have not been established.