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DORAL® (quazepam tablets) 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® (quazepam tablets) has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of DORAL® (quazepam tablets) 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® (quazepam tablets) 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.
DOSAGE AND ADMINISTRATION
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® (quazepam tablets) 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 (quazepam tablets) ) on the other.
7.5 mg Bottles of 100 NDC 63004-7735-1
DORAL® (quazepam tablets) 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 (quazepam tablets) ) on the other.
15 mg Bottles of 100 NDC 63004-7734-1
Store DORAL® (quazepam tablets) 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.
Last reviewed on RxList: 4/30/2010
This monograph has been modified to include the generic and brand name in many instances.
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