Zolpidem tartrate 12.5 MG Extended Release Tablet
1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets are indicated for the 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 tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
Actavis Pharma, Inc.
ROUND YELLOW A1
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16 HOW SUPPLIED/STORAGE AND HANDLING Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg are composed of two portions* and are white, round, biconvex, unscored, coated tablets debossed with A2 on one side and plain on the other side and supplied as: NDC Number Size 0228-3481-11 bottle of 100 Each tablet contains 6.25 mg of zolpidem tartrate, USP. Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg are composed of two portions* and are yellow, round, biconvex, unscored, coated tablets debossed with A1 on one side and plain on the other side and supplied as: NDC Number Size 0228-3482-11 bottle of 100 Each tablet contains 12.5 mg of zolpidem tartrate, USP. *Portions are covered by the coating and are indistinguishable. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container as defined in the USP.
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