zolpidem 5 mg

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, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )

Teva Pharmaceuticals USA, Inc.

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

5 years ago

ROUND PINK TEVA 73

16 HOW SUPPLIED/STORAGE AND HANDLING

ZOLPIDEM TARTRATE tablets, USP are available as follows: 5 mg: pink, film-coated, round tablets, debossed "TEVA" on one side of the tablet and “73” on the other. They are available in bottles of 100 (NDC 0093-0073-01). 10 mg: white to off-white, film-coated, round tablets, debossed "TEVA" on one side of the tablet and “74” on the other. They are available in bottles of 100 (NDC 0093-0074-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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