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Suvorexant in Insomnia Co-morbid With Fibromyalgia

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Timothy Roehrs, PhD, Henry Ford Health System
Information provided by (Responsible Party):
Timothy Roehrs, PhD, Henry Ford Health System Identifier:
First received: January 22, 2016
Last updated: February 22, 2017
Last verified: February 2017
This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.

Condition Intervention Phase
Insomnia Fibromyalgia Drug: suvorexant Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Crossover, Study to Compare the Hypnotic, Daytime Sleepiness/Fatigue, and Pain Effects of Nighttime Administration of Suvorexant 20 mg Versus Placebo in Patients With Fibromyalgia and Comorbid Insomnia

Resource links provided by NLM:

Further study details as provided by Timothy Roehrs, PhD, Henry Ford Health System:

Primary Outcome Measures:
  • polysomnographic assessment of sleep [ Time Frame: continuous sleep recording from 11pm to 7am on night 8 ]
    total sleep time on 8 hr standard sleep recording

Secondary Outcome Measures:
  • daytime pain sensitivity [ Time Frame: testing at 1100 and 1500 hrs on day 1 and day 8 ]
    finger withdrawal response to a radiant heat stimulus when pain is first experienced

Estimated Enrollment: 30
Study Start Date: February 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: suvorexant
9 nights of 20 mg suvorexant
Drug: suvorexant
suvorexant 20 mg taken before sleep
Other Name: belsomra
Placebo Comparator: placebo
9 nights placebo
Drug: placebo
placebo taken before sleep
Other Name: matching placebo

Detailed Description:

It has now become clear that the relation of sleep and pain is bidirectional; acute and chronic pain is associated with disturbed sleep and disturbed sleep enhances pain. Experimental studies have shown that reduced and fragmented sleep in pain-free normals increases their pain sensitivity and daily self-report studies in chronic pain patients have shown a poor night of sleep is followed by enhanced next-day pain. In mediation analyses of large clinical data sets it is found that the sleep-pain side of the bidirectional relation, as opposed to the pain-sleep side, accounts for the greater variance. These data then would suggest that improving sleep in chronic pain disorders should attenuate daytime pain.

Most of the drugs used to treat chronic pain facilitate inhibitory central nervous system mechanisms as their primary mechanism of action. Suvorexant, recently approved by the FDA for the treatment of insomnia characterized by difficulties with sleep onset and sleep maintenance, has a unique mechanism of action. Suvorexant is a selective antagonist for orexin receptors (OX1R and OX2R). Orexins are considered to be involved in arousal and maintenance of the waking state.

As such, suvorexant may provide unique clinical benefit as a treatment in chronic pain conditions with co-morbid insomnia, and specifically for fibromyalgia with its putative central hyperarousal and hypersensitization. Thus, this project proposes to study objective and clinical measures of sleep, pain, and daytime sleepiness and fatigue in patients with fibromyalgia and co-morbid insomnia while treated short-term with suvorexant 20 mg versus placebo.

Those qualifying will receive suvorexant 20 mg and placebo for each of 9 nights in a cross over design with 7 nights of washout between treatments. Overnight sleep recordings (PSGs) will be collected on nights 7 and 8 of each crossover treatment arm to determine objective sleep measures. During the day following night 7 in each arm, a Multiple Sleep Latency Test (MSLT) at 1000, 1200, 1400, and 1600 hr will be conducted and nociceptive sensitivity [finger withdrawal latency (FWL)] testing to a radiant heat stimulus (1100 and 1500 hr) will be conducted on day 1 and day 8. Self-reported mood and pain indices will also be completed prior to each FWL test.

Primary outcomes to be measured include PSG sleep efficacy and FWL response on both conditions (suvorexant 20 mg versus placebo).


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • meet Diagnostic and Statistical Manual 5th ed criteria for insomnia
  • meet American College of Rheumatology criteria for fibromyalgia
  • otherwise good psychiatric and stable physical health

Exclusion Criteria:

  • other primary sleep disorders
  • pain symptoms unrelated to fibromyalgia
  • current pregnancy or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02684136

Contact: Dana Withrow, MHA 313-916-5302
Contact: Gail Koshorek, BS 313-916-5179

United States, Michigan
HFHS Sleep Disorders Ctr Recruiting
Detroit, Michigan, United States, 48202
Contact: Gail Koshorek, BS    313-916-5179   
Contact: Dana Withrow, MHA    313-916-5302   
Sponsors and Collaborators
Henry Ford Health System
Principal Investigator: Timothy Roehrs, PhD Henry Ford Health System
Study Chair: Thomas Roth, PhD Henry Ford Health System
  More Information

Responsible Party: Timothy Roehrs, PhD, Senior Bioscientist, Henry Ford Health System Identifier: NCT02684136     History of Changes
Other Study ID Numbers: FM16
Study First Received: January 22, 2016
Last Updated: February 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Timothy Roehrs, PhD, Henry Ford Health System:
pain management

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 25, 2017