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, 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)

aurobindo pharma limited

FDA Reported Adverse Reactions
`[1] chronic kidney disease` `[2] drug ineffective` `[3] acute kidney injury` `[4] nausea` `[5] pain` `[6] fatigue` `[7] renal failure` `[8] headache` `[9] diarrhoea` `[10] dyspnoea`

4 years ago

ROUND WHITE E 78

4 years ago

E 78 ROUND WHITE

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 65862-159-01 Bottles of 500 NDC 65862-159-05 Bottles of 1,000 NDC 65862-159-99 10 x 10 Unit-dose Tablets NDC 65862-159-10

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 65862-160-01 Bottles of 500 NDC 65862-160-05 Bottles of 1,000 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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Aurobindo Pharma Limited

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