From the ANA Annual Meeting: Eszopiclone demonstrates long-term safety and efficacy in 6-month study

Results from a 6-month, phase 3b/4 study of eszopiclone (Lunesta, Sepracor) in adult patients with chronic insomnia demonstrated that nightly use of eszopiclone 3 mg resulted in statistically significant improvements (P<.0001) compared with placebo in patient-reported measures of sleep latency (onset of sleep), sleep maintenance, total sleep time, and sleep quality. These results were announced in late September at the American Neurological Association (ANA) Annual Meeting in San Diego, Calif.

The long-term, 828-patient, randomized, double-blind, placebo-controlled study evaluating safety and efficacy of eszopiclone also included a 2-week discontinuation phase in which all patients were administered placebo.

Patients in the study who were treated with eszopiclone reported improved daytime measures, including ability to function (P<0.0001), improved daytime alertness (P<.0001), improved ability to think and concentrate clearly (P<.0001), and improved sense of physical well-being (P<.0001), versus placebo. These differences were apparent in the first month of treatment and were maintained throughout all 6 months of nightly treatment.

"Chronic insomnia has been frequently treated with long-term administration of medications, while studies of nightly treatment with these medications only examined durations of 5 weeks or less. The first 6-month eszopiclone study established the feasibility of the type of longer-term studies needed to guide clinical practice and provided the first clinical study evidence of safety and sustained efficacy over a duration of well beyond 1 month," said Andrew Krystal, MD, director of the Sleep Disorder Research Laboratory and Insomnia Program at Duke University Medical Center and a lead investigator for the study.

"Together, the results of these 2 large-scale, placebo-controlled studies provide evidence that tolerance and withdrawal are not characteristics of nightly treatment with eszopiclone 3 mg for periods as long as 6 months" Dr Krystal said. "These data represent the first solid empirical basis for making clinical decisions regarding a medication of the sort needed in the management of the many patients suffering from chronic insomnia."

Patients aged 21 to 64 years with chronic insomnia received nightly treatment with either placebo (n=280) or eszopiclone 3 mg (n=548). Efficacy end points, including patient-reported sleep latency, total sleep time, sleep maintenance measures (wake time after sleep onset, number of awakenings and number of nights awakened), quality of sleep, as well as next-day ratings of ability to function, daytime alertness, ability to concentrate, and sense of physical well-being, were each evaluated weekly during the double-blind phase.

This study is the second long-term, 6-month, double-blind, placebo-controlled study of eszopiclone in patients with chronic insomnia. The results of this study augment the findings of the first 6-month study, which was published in the journal Sleep in November 2003.