Sepracor’s Lunesta shines in second long-term study

The study, which included 828 patients with chronic insomnia, augments the findings in Sepracor’s first landmark, six-month study of Lunesta (eszopiclone). 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 3mg 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 treated with Lunesta also 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.

“This replication of results in the second six-month, double-blind, placebo-controlled study of eszopiclone is noteworthy,” said Dr John Winkelman, associate director for the sleep disorders program at Brigham and Women’s Hospital, Boston. “This study should provide the medical community with confidence in the findings of the first six-month study and raise the bar in examining insomnia agents for long-term use.”

Lunesta is now available by prescription in most pharmacies nationwide after Sepracor began a full-scale commercial launch on April 4, 2005. It is currently indicated for the treatment of insomnia in patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night.

With the replication of results of measures of next-day function and sleep quality in this second long-term study of Lunesta, Sepracor plans to review the information with the FDA for potential revision of the product label.