Prosom (Estazolam) - Indications and Dosage

INDICATIONS AND USAGE

ProSom (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 ProSom administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY).

Because insomnia is often transient and intermittent, the prolonged administration of ProSom 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 ProSom 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

ProSom tablets are scored tablets supplied as

ProSom Tablets 1 mg white tablets bearing the Abbott logo and UC (Abbo-Code). Bottles of 100 (NDC 0074-3735-13)

ProSom Tablets 2 mg pink tablets bearing the Abbott logo and UD (Abbo-Code). Bottles of 100 (NDC 0074-3736-13).

Recommended Storage

Store below 86°F (30°C).

Mfd. by Abbott Pharmaceuticals PR Ltd.
Barceloneta, PR 00617

for

Abbott Laboratories, North Chicago, IL, 60064, USA