Eszopiclone 1 mg
1 INDICATIONS AND USAGE Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance ( 1 )
Mylan Pharmaceuticals Inc.
ROUND ORANGE M EZ 1
M EZ 1 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ESZOPICLONE Tablets, USP are available containing 1 mg, 2 mg or 3 mg of
ESZOPICLONE, USP. The 1 mg tablets are buff, film-coated, round, unscored tablets debossed with M on one side of the tablet and EZ over 1 on the other side. They are available as follows: NDC 0378-5270-01 bottles of 100 tablets The 2 mg tablets are buff, film-coated, round, unscored tablets debossed with M on one side of the tablet and EZ over 2 on the other side. They are available as follows: NDC 0378-5271-01 bottles of 100 tablets The 3 mg tablets are buff, film-coated, round, unscored tablets debossed with M on one side of the tablet and EZ over 3 on the other side. They are available as follows: NDC 0378-5272-01 bottles of 100 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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