Zolpidem Tartrate Zolpidem tartrate 10 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, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )

Mylan Pharmaceuticals Inc.

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

7 years ago

ROUND PURPLE M Z2

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.

More pills like ROUND M Z2

Related Pills

zolpidem tartrate tablet film coated

mylan pharmaceuticals inc.

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site