Zolpidem tartrate 12.5 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Zolpidem Tartrate Extended-Release Tablets, USP, 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 agonist are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
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ROUND WHITE A116
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16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50436-0116
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