zolpidem tartrate tablet coated
1 INDICATIONS AND USAGE Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14 )]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
sandoz inc
ROUND YELLOW ZLP 10
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16 HOW SUPPLIED/STORAGE AND HANDLING
ZOLPIDEM TARTRATE tablets, USP are available as follows: 5 mg, are white, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 5 on the other side. NDC 0781-5317-31, bottle of 30 tablets NDC 0781-5317-01, bottle of 100 tablets NDC 0781-5317-05, bottle of 500 tablets NDC 0781-5317-10, bottle of 1000 tablets 10 mg, are yellow, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 10 on the other side. NDC 0781-5318-31, bottle of 30 tablets NDC 0781-5318-01, bottle of 100 tablets NDC 0781-5318-05, bottle of 500 tablets NDC 0781-5318-10, bottle of 1000 tablets Store at controlled room temperature 20° to 25°C (68° to 77°F).
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