zolpidem tartrate tablet extended release
1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).) The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES ( 14 )]. Zolpidem tartrate extended-release tablet, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
lupin pharmaceuticals, inc.
ROUND PINK LU E61
LU E61 ROUND PINK
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zolpidem tartrate tablet extended release
lupin pharmaceuticals, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ZOLPIDEM TARTRATE extended-release tablets USP, 6.25 mg are composed of two layers * and are pink colored, round, biconvex, film-coated tablets debossed with "E61" on one side and "LU" on the other side and supplied as: NDC Number Package Configuration 68180-779-04 Bottle of 100
ZOLPIDEM TARTRATE extended-release tablets USP, 12.5 mg are composed of two layers * and are blue colored, round, biconvex, film-coated tablets debossed with "E62" on one side and "LU" on the other side and supplied as: NDC Number Package Configuration 68180-780-04 Bottle of 100 *Layers are covered by the coating and are indistinguishable. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
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