Zolpidem tartrate 5 MG Oral Tablet
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 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)
RedPharm Drug, Inc.
ROUND WHITE E 78
E 78 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Zolpidem Tartrate Tablets, 5 mg are white to off-white, circular, biconvex, film-coated tablets, debossed with “E” on one side and “78” on the other side. Bottles of 100 NDC 65862-159-01 Bottles of 500 NDC 65862-159-05 Bottles of 1000 NDC 65862-159-99 10 x 10 Unit-dose Tablets NDC 65862-159-10 Zolpidem Tartrate Tablets, 10 mg are white to off-white, oval shaped, biconvex, film-coated tablets, debossed with “E” on one side and “79” on the other side. Bottles of 100 NDC 65862-160-01 Bottles of 500 NDC 65862-160-05 Bottles of 1000 NDC 65862-160-99 10 x 10 Unit-dose Tablets NDC 65862-160-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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