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, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
Mylan Pharmaceuticals Inc.
ROUND PURPLE M Z1
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zolpidem tartrate tablet film coated
mylan pharmaceuticals inc.
Zolpidem Tartrate Zolpidem tartrate 10 MG Oral Tablet
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Zolpidem Tartrate Tablets, USP are available containing 5 mg or 10 mg of zolpidem tartrate, USP. The 5 mg tablets are Lavender, film-coated, round, unscored tablets debossed with M over Z1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5305-01 bottles of 100 tablets NDC 0378-5305-05 bottles of 500 tablets The 10 mg tablets are Lavender, film-coated, round, unscored tablets debossed with M over Z2 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5310-01 bottles of 100 tablets NDC 0378-5310-05 bottles of 500 tablets 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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