Estazolam (Estazolam) - Indications and Dosage

INDICATIONS AND USAGE

Estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY).

Because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor 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.

There is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

The recommended initial dose for adults is 1 mg at bedtime; however, some patients may need a 2 mg dose. In healthy elderly patients, 1 mg is also the appropriate starting dose, but increases should be initiated with particular care. In small or debilitated older patients, a starting dose of 0.5 mg, while only marginally effective in the overall elderly population, should be considered.

HOW SUPPLIED

Estazolam Tablets 1 mg are available as white, oval, biconvex, double-scored tablets debossed “93”–“129” on one side. Packaged in bottles of 100 and 1000.

Estazolam Tablets 2 mg are available as coral, oval, biconvex, single-scored tablets debossed “93”–“130” on the scored side. Packaged in bottles of 100 and 1000.

Store at controlled room temperature, between 20° and 25°C (68°and 86°F) (see USP).

Dispense in a tight, light-resistant container as defined in the USP/NF, with a child-resistant closure (as required).

Manufactured By:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. D 1/2004