Lunesta Second Six-Month Study Data Confirms First Six-Month Study Data

Sepracor has announced preliminary results from its second six-month, Phase IIIb/IV, randomized, double-blind, placebo-controlled safety and efficacy study of Lunesta brand eszopiclone for the treatment of insomnia.

The study, which included 828 patients with chronic insomnia, augments the findings in Sepracor's first landmark, six-month study of Lunesta. This long-term study included a two-week discontinuation phase, which showed no evidence of treatment-related rebound insomnia or withdrawal symptoms.

In this study, nightly use of Lunesta 3 mg resulted in statistically significant improvement compared with placebo in patient-reported measures of sleep latency (onset of sleep), sleep maintenance, total sleep time and sleep quality. Patients in this study who were treated with Lunesta reported improved ability to function, improved daytime alertness, improved ability to concentrate, and improved sense of physical well-being, versus placebo. These differences were apparent in the first month of treatment and were maintained throughout six months of nightly treatment, the company said. Lunesta was well-tolerated over the treatment period.