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Suvorexant in Insomnia Co-morbid With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT02684136
Recruitment Status : Terminated (reduced ability to recruit sufficient number of patients)
First Posted : February 17, 2016
Results First Posted : April 28, 2021
Last Update Posted : June 16, 2021
Information provided by (Responsible Party):
Timothy Roehrs, PhD, Henry Ford Health System

Brief Summary:
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 or disease Intervention/treatment Phase
Insomnia Fibromyalgia Drug: suvorexant Drug: placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : February 1, 2016
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Suvorexant

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Daytime Pain Sensitivity [ Time Frame: mean of tests at 1100 and 1500 hrs on both day 1 and day 8 ]
    finger withdrawal response to a radiant heat stimulus when pain is first experienced

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684136

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United States, Michigan
HFHS Sleep Disorders Ctr
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
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Principal Investigator: Timothy Roehrs, PhD Henry Ford Health System
Study Chair: Thomas Roth, PhD Henry Ford Health System
  Study Documents (Full-Text)

Documents provided by Timothy Roehrs, PhD, Henry Ford Health System:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Timothy Roehrs, PhD, Senior Bioscientist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02684136    
Other Study ID Numbers: FM16
First Posted: February 17, 2016    Key Record Dates
Results First Posted: April 28, 2021
Last Update Posted: June 16, 2021
Last Verified: April 2021
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:
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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
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action