DORAL® Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of DORAL® has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of DORAL® has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration.

Because insomnia is often transient and intermittent, the prolonged administration of DORAL® Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.

Adults: Initiate therapy at 15 mg until individual responses are determined. In some patients, the dose may then be reduced to 7.5 mg.

Elderly and Debilitated Patients: Because the elderly and debilitated may be more sensitive to benzodiazepines, attempts to reduce the nightly dosage after the first 1-2 nights of therapy are suggested.

Geriatric Patients: A double-blind controlled sleep laboratory study (N=30) compared the effects of quazepam 7.5 mg and 15 mg to that of placebo over a period of 7 days. Both the 7.5 mg and 15 mg doses appeared to be well tolerated. Caution must be used in interpreting this data due to the small size of the study; therefore, initiate therapy in geriatric patients at 7.5 mg. If not effective after 1-2 nights, the dosage may be increased to 15 mg.

DORAL® Tablets, 7.5 mg, unscored, capsule-shaped, light orange, slightly white speckled tablets, impressed with the product identification number 7.5 on one side of the tablet, and the product name (DORAL) on the other.

7.5 mg................Bottles of 100..............NDC 63004-7735-1

DORAL® Tablets, 15 mg, unscored, capsule-shaped, light orange, slightly white speckled tablets, impressed with the product identification number 15 on one side of the tablet, and the product name (DORAL) on the other.

15 mg................Bottles of 100...............NDC 63004-7734-1

Store DORAL® Tablets at controlled room temperature 20°-25°C (68°-77°F).

Manufactured for: Questcor Pharmaceuticals, Inc. Union City, CA 94587, USA. Manufactured by: MedPointe Pharmaceuticals, MedPointe Healthcare Inc. Somerset, NJ 08873. Under license from Baker Norton Pharmaceuticals Inc. FDA Rev date: 10/30/2007

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