A six month, randomized, double-blind and six month open-label extension, multi-center, outpatient study to determine the safety of eszopiclone in the treatment of adult subjects with primary insomnia. Approximately 800 subjects were to be randomized using a 3:1 ratio to receive one of the two treatments, eszopiclone 3 mg or placebo, for 6 months. All subjects completing 6 months of treatment were eligible to receive open-label 3 mg eszopiclone for an additional 6 months. Subjects were allowed to stay on study for up to 12 months.
A six-month study to determine the safety and efficacy with an additional open-label extension to determine the long-term safety of eszopiclone in the treatment of adult subjects with primary insomnia.