Suvorexant in Insomnia Co-morbid With Fibromyalgia
| Status: | Terminated |
|---|---|
| Conditions: | Fibromyalgia, Insomnia Sleep Studies, Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Rheumatology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 8/12/2018 |
| Start Date: | February 1, 2016 |
| End Date: | July 1, 2018 |
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.
co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.
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).
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).
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
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