zolpidem 10 mg
1 INDICATIONS AND USAGE Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has 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 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartrate Tablets, 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 )
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ROUND WHITE IT 118
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16 HOW SUPPLIED/STORAGE AND HANDLING
ZOLPIDEM TARTRATE Tablets, USP 5 mg is pink film coated, round biconvex tab lets, debossed "IT 117" on one side, other side is plain and supplied as: NDC Number Size 71093-155-04 bottle of 100 71093-155-06 bottle of 1000
ZOLPIDEM TARTRATE Tablets, USP 10 mg is white film coated, round biconvex tab lets, debossed "IT 118" on one side, other side is plain and supplied as: NDC Number Size 71093-156-04 bottle of 100 71093-156-06 bottle of 1000 Store at controlled room temperature 20°C-25°C (68°F-77°F).
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