Eszopiclone Prescribing Information
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).
Use the lowest effective dose for the patient.
Eszopiclone tablets are available in 1 mg, 2 mg and 3 mg strengths for oral administration.
Eszopiclone tablets 3 mg, are dark blue colored, biconvex, round shaped film coated, debossed with “E” on one side and “3” on other side.
Eszopiclone tablets 2 mg, are white to off-white colored, biconvex, round shaped film coated, debossed with “E” on one side and “2” on other side.
Eszopiclone tablets 1 mg, are light blue colored, biconvex, round shaped film coated, debossed with “E” on one side and “1” on other side.
- Pediatric Use:Safety and effectiveness not established. Dizziness, dysgeusia, hallucinations, suicidal ideation reported
Eszopiclone is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone [
Eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [