Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Inclusion criteria

• Be between the ages of 18 to 64
• Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
• Sleep difficulties at least 2x per week in the preceding month
• Be on a stable dose of antipsychotic medication
• Symptomatically stable in the last 2 months
• English speaking.

Exclusion criteria

• Meet criteria for current alcohol or other substance dependence
• A history of dementia, mental retardation or other neurological disorder
• Not capable of giving informed consent for participation in this study.
• Ongoing pregnancy
• Known sensitivity to zopiclone.
• Insomnia associated with medical disorders likely to impair sleep.
• Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.
• Lack of sleep benefit from previous adequate eszopiclone treatment
• History of clinically significant hepatic impairment.
• Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.