Suvorexant in Insomnia Co-morbid With Fibromyalgia

May 26, 2021 updated by: Timothy Roehrs, PhD, Henry Ford Health System

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • HFHS Sleep Disorders Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: suvorexant
9 nights of 20 mg suvorexant
Drug: suvorexant
suvorexant 20 mg taken before sleep
Other Names:
  • belsomra
PLACEBO_COMPARATOR: placebo
9 nights placebo
Drug: placebo
placebo taken before sleep
Other Names:
  • matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
continuous sleep recording from 11pm to 7am on night 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
mean of tests at 1100 and 1500 hrs on both day 1 and day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Timothy Roehrs, PhD, Henry Ford Health System
  • Study Chair: Thomas Roth, PhD, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (ESTIMATE)

February 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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