Eszopiclone in the Treatment of Insomnia and Fibromyalgia

Inclusion Criteria

• Male or female, age 18 through 64.
• Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.
• Reports sleep maintenance insomnia (total sleep time of 30 minutes), as well as clinically significant daytime distress or impairment during the 1 week self assessment prior to baseline.
• Has completed 8th grade and is fluent in English.
• If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Acceptable birth control methods include: history of tubal ligation, having a male partner who is sterile, IUDs, birth control pills or other hormonal birth control methods (e.g., birth control patch, Depo-Provera injections), and double-barrier methods (e.g., condom and foam).
• Antidepressant medication will be allowed if the patient has been on a stable dose for at least one month.

Exclusion Criteria

• Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.
• Evidence of a primary sleep disorder (e.g., significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder, or REM sleep behavior disorder.
• Any current, clinically significant medical condition.
• Pregnancy.
• Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.
• Any current psychiatric disorder that would interfere with study participation (investigator judgment).
• Active suicidal ideation.
• Plans to engage in additional psychotherapy during the study.
• Concurrent use of benzodiazepines after 6pm or as a sleep aid.
• Concurrent use of any other sleep aid.
• Concurrent use of analgesics other than acetaminophen or non-steroidal anti-inflammatory medication.
• Concurrent use of any medication that has not been stabilized for at least 1 month prior to screening.