Eszopiclone in the Treatment of Insomnia and Fibromyalgia
Condition: Fibromyalgia; Insomnia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Initiation and Maintenance Disorders
Intervention: Eszopiclone; placebo
Intervention description: 3mg qpm for 12 weeks; 1 pill qpm for 12 weeks
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Insomnia; Sleep; Eszopiclone; Lunesta

Summary:

      The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other
      symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will
      report greater improvement in total sleep time, sleep quality, pain, fatigue, physical
      functioning, and emotional distress than will those receiving placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age 18 through 64.

          2. Meets ACR criteria for FMS, as determined by rheumatological examination and a medical
             history review.

          3. Reports sleep maintenance insomnia (total sleep time of < 6.5 hours or sleep
             impairment consisting of 3 of 7 nights per week for a month by history) or sleep onset
             latency insomnia (at least 3 of 7 nights of sleep latency > 30 minutes), as well as
             clinically significant daytime distress or impairment during the 1 week self
             assessment prior to baseline.

          4. Has completed 8th grade and is fluent in English.

          5. 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).

          6. Antidepressant medication will be allowed if the patient has been on a stable dose for
             at least one month.

        Exclusion Criteria:

          1. Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or
             endocrine-related arthropathy.

          2. 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.

          3. Any current, clinically significant medical condition.

          4. Pregnancy.

          5. Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain
             syndrome, or psychoactive substance abuse or dependence.

          6. Any current psychiatric disorder that would interfere with study participation
             (investigator judgment).

          7. Active suicidal ideation.

          8. Plans to engage in additional psychotherapy during the study.

          9. Concurrent use of benzodiazepines after 6pm or as a sleep aid.

         10. Concurrent use of any other sleep aid.

         11. Concurrent use of analgesics other than acetaminophen or non-steroidal
             anti-inflammatory medication.

         12. Concurrent use of any medication that has not been stabilized for at least 1 month
             prior to screening.