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.
Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome. Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Participants will be randomly selected to receive eszopiclone or placebo. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
3mg qpm for 12 weeks
1 pill qpm for 12 weeks
Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School
Piscataway, New Jersey, United States
Change in Total Sleep Time (TST) as Recorded in Patient Diaries
Difference in total sleep time between week 4 and baseline
Time frame: week 4
Wake Time After Sleep Onset (WASO)
Minutes awake after sleep onset as recorded in patient diaries
Time frame: week 12
Sleep Quality
Time frame: week 12
Clinician-rated Overall Severity of Fibromyalgia
Time frame: week 12
Fibromyalgia Impact Questionnaire
Time frame: week 12
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