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DORAL® (quazepam) is 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.
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient, as important adverse effects of Doral are dose related.
The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy.
The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line.
Elderly and debilitated patients may be more sensitive to benzodiazepines.
Dosage Forms And Strengths
Tablets, 15 mg, functionally scored, 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.
DORAL Tablets, 15 mg, functionally scored, 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. Hayward, CA 94545 USA phone (800) 411-3065, (510) 400-0700 fax (510) 400-0799. Manufactured by: Meda Pharmaceuticals, Inc. Somerset, NJ 08873-4120, Under license from Baker Norton Pharmaceuticals, Inc. Rev. 04/13
Last reviewed on RxList: 5/28/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Doral Information
Doral - User Reviews
Doral User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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