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, a gamma-aminobutyric acid (GABA) are A agonist, 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. ( 1 )
Aphena Pharma Solutions - Tennessee, Inc.
16 HOW SUPPLIED/STORAGE AND HANDLING Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Zolpidem Tartrate Tablets are available as: 5 mg, pink, film-coated, capsule-shaped, unscored, debossed "6468" on one side and debossed "V" on the reverse side, available as follows: Bottles of 10: NDC 0603-6468-10 Bottles of 20: NDC 0603-6468-09 Bottles of 30: NDC 0603-6468-16 Bottles of 100: NDC 0603-6468-21 Bottles of 500: NDC 0603-6468-28 Bottles of 1000: NDC 0603-6468-32 10 mg, white, film-coated, capsule-shaped, unscored, debossed "6469" on one side and debossed "V" on the reverse side, available as follows: Bottles of 10: NDC 0603-6469-10 Bottles of 15: NDC 0603-6469-13 Bottles of 20: NDC 0603-6469-09 Bottles of 30: NDC 0603-6469-16 Bottles of 60: NDC 0603-6469-20 Bottles of 90: NDC 0603-6469-02 Bottles of 100: NDC 0603-6469-21 Bottles of 500: NDC 0603-6469-28 Bottles of 1000: NDC 0603-6469-32 Store at controlled room temperature 20Â° to 25Â°C (68Â° to 77Â°F) [see USP Controlled Room Temperature].
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