zolpidem tartrate tablet film 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, 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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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] pain` `[5] headache` `[6] off label use` `[7] dyspnoea` `[8] diarrhoea` `[9] vomiting` `[10] arthralgia`

6 years ago

OVAL WHITE 79

16 HOW SUPPLIED/STORAGE AND HANDLING

ZOLPIDEM TARTRATE Tablets USP, 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 16714-621-01 Bottles of 500 NDC 16714-621-02 10 x 10 Unit-dose Tablets NDC 16714-621-11

ZOLPIDEM TARTRATE Tablets USP, 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 16714-622-01 Bottles of 500 NDC 16714-622-02 10 x 10 Unit-dose Tablets NDC 16714-622-11 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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