Restoril (Temazepam) - Indications and Dosage

INDICATIONS AND USAGE

Restoril^® (temazepam) is indicated for the short-term treatment of insomnia (generally 7-10 days).

For patients with short-term insomnia, instructions in the prescription should indicate that Restoril^® (temazepam) should be used for short periods of time (7-10 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.

DOSAGE AND ADMINISTRATION

While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

HOW SUPPLIED

Restoril^® (temazepam capsules USP)

7.5 mg

Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and

                  Bottle of 30. .. .. .. .. .NDC 0406-9915-03

                  Bottle of 100. .. .. .. ..NDC 0406-9915-01

15 mg

Maroon and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and

                  Bottle of 100. .. .. .. ..NDC 0406-9916-01

                  Bottle of 500. .. .. .. ..NDC 0406-9916-05

22.5 mg

Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and

                  Bottle of 30. .. .. .. .. .NDC 0406-9914-03

                  Bottle of 100. .. .. .. ..NDC 0406-9914-01

30 mg

Maroon and blue capsules, with the blue body imprinted “FOR SLEEP” on one side and

                  Bottle of 100. .. .. .. ..NDC 0406-9917-01

                  Bottle of 500. .. .. .. ..NDC 0406-9917-05

Dispense in a well-closed, light-resistant container with a child-resistant closure.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].