Temazepam

Temazepam is indicated for the short term treatment of sleep disturbances, considered severe or disabling or where insomnia is subjecting the individual to extreme distress. This product is especially useful in those patients for whom particularly rapid onset of hypnotic action is required and for whom the persistence of hypnotic effect after rising would be undesirable.

Temazepam is particularly suitable for patients with transient sleep disorders in whom re-establishment of normal sleep patterns is expected following the resolution of precipitating factors. It is also indicated for pre-medication for minor surgical and investigative procedures, especially in the case of outpatients.

RESTORIL (temazepam) is indicated for the symptomatic relief of transient and short-term insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings. The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning.

1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.

Long-term use of RESTORIL should be avoided in elderly patients. 1 Dosing considerations).

INDICATIONS & USAGE

Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days).

The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.