Eszopiclone in the Treatment of Insomnia and Fibromyalgia

Eszopiclone in the Treatment of Insomnia and Associated Symptoms of Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Fibromyalgia
• Intervention / Treatment: Drug: Eszopiclone; Drug: placebo

Detailed Description

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
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; 1 pill qpm for 12 weeks
Experimental: Eszopiclone	Drug: Eszopiclone; 3mg qpm for 12 weeks; Other Names: Lunesta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Sleep Time (TST) as Recorded in Patient Diaries	Difference in total sleep time between week 4 and baseline	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wake Time After Sleep Onset (WASO)	Minutes awake after sleep onset as recorded in patient diaries	week 12
Sleep Quality		week 12
Clinician-rated Overall Severity of Fibromyalgia		week 12
Fibromyalgia Impact Questionnaire		week 12

Collaborators and Investigators

• Sponsor: Lesley A. Allen, Ph.D.
• Collaborators: Sunovion
• Investigators: Principal Investigator: Lesley A. Allen, Ph.D., Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: October 24, 2006
• First Submitted That Met QC Criteria: October 24, 2006
• First Posted (Estimate): October 25, 2006

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Sleep; Insomnia; Fibromyalgia; Eszopiclone; Lunesta
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Sleep Initiation and Maintenance Disorders; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: 0220060122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No