Quazepam (Quazepam) - Indications and Dosage

INDICATIONS AND USAGE

QUAZEPAM^® (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 QUAZEPAM has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of QUAZEPAM 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 QUAZEPAM 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 QUAZEPAM 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.

Special Populations

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 (QUAZEPAM) on the other.

HOW SUPPLIED / STORAGE AND HANDLING

QUAZEPAM 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 (QUAZEPAM) on the other.

15 mg             Bottles of 100             NDC 63004-7334-1

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