eszopiclone
Drug Details
- Generic Name
- eszopiclone
- Brand Names
- Eszopiclone
- Application Number
- ANDA091151
- Sponsor
- Patheon Inc.
- NDC Codes
- 9
- Dosage Forms
- TABLET, COATED, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ESZOPICLONE
Indications and Usage
1 INDICATIONS & 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 has been shown to decrease sleep latency and improve sleep maintenance ( 1 )