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Indications
Dosage
How Supplied

INDICATIONS

Estazolam tablets are indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both out-patient 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, USP 1 mg are white, scored, diamond shaped compressed tablets imprinted with WATSON on one side of the tablet and on the other side with 744 on the left side of the score and 1 on the right side of the score, supplied in bottles of 100.

Estazolam tablets, USP 2 mg are dark pink, scored, diamond shaped compressed tablets imprinted with WATSON on one side of the tablet and on the other side with 745 on the left side of the score and 2 on the right side of the score, supplied in bottles of 100.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA. Revised: Nov 2014.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/23/2017

Indications
Dosage
How Supplied

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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