Zolpidem tartrate 10 mg

1 INDICATIONS AND USAGE Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP 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.

Torrent Pharmaceuticals Limited

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

5 years ago

OVAL YELLOW LOGO 10 MG

16 HOW SUPPLIED/STORAGE AND HANDLING

ZOLPIDEM TARTRATE 5 mg tablets, USP are red colored, capsule shaped tablets with the Torrent logo debossed on one side and '5 MG' debossed on the other side and supplied as: NDC Number Size 13668-007-30 bottle of 30 13668-007-90 bottle of 90 13668-007-01 bottle of 100 13668-007-05 bottle of 500 13668-007-10 bottle of 1000 13668-007-15 bottle of 1500

ZOLPIDEM TARTRATE 10 mg tablets, USP are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and '10 MG' debossed on the other side and supplied as: NDC Number Size 13668-008-30 bottle of 30 13668-008-90 bottle of 90 13668-008-01 bottle of 100 13668-008-05 bottle of 500 13668-008-10 bottle of 1000 13668-008-15 bottle of 1500 Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59º to 86°F) [see USP Controlled Room Temperature].