Dalmane is a hypnotic agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Dalmane can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have objectively determined that Dalmane is effective for at least 28 consecutive nights of drug administration. Since insomnia is often transient and intermittent, short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient.

Dosage should be individualized for maximal beneficial effects. The usual adult dosage is 30 mg before retiring. In some patients, 15 mg may suffice. In elderly and/or debilitated patients, 15 mg is usually sufficient for a therapeutic response and it is therefore recommended that therapy be initiated with this dosage.

Dalmane (flurazepam hydrochloride) Capsules are available in the following presentations:

15 mg hard gelatin capsules in bottles of 100 (NDC 0187-4051-10), with ICN logo imprinted on the opaque orange cap and Dalmane® 15 imprinted on the opaque ivory body.

30 mg hard gelatin capsules in bottles of 100 (NDC 0187-4052-10), with ICN logo imprinted on the opaque red cap and Dalmane® 30 imprinted on the opaque ivory body.

Store at 25ºC (77ºF); excursions permitted to 15Cº-30ºC (59ºF-86ºF). [See USP Controlled Room Temperature]

Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656. Rev. April 2007. FDA rev date: 10/30/2007

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