Suvorexant in Insomnia Co-morbid With Fibromyalgia

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.

Timeline

Start

2016-02-01

Primary completion

2018-07-01

Completion

2018-07-01

Outcome

Met primary endpoint

Stopped (Enrollment): “reduced ability to recruit sufficient number of patients”

registry MEAN Suvorexant: 429.3 (Standard Deviation 29.4) min NCT02684136 ↗

registry analysis (superiority test); Suvorexant vs Placebo; p <0.05; ANCOVA NCT02684136 ↗

Publications

• Background Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
• Background Roehrs T, Diederichs C, Gillis M, Burger AJ, Stout RA, Lumley MA, Roth T. Nocturnal sleep, daytime sleepiness and fatigue in fibromyalgia patients compared to rheumatoid arthritis patients and healthy controls: a preliminary study. Sleep Med. 2013 Jan;14(1):109-15. doi: 10.1016/j.sleep.2012.09.020. Epub 2012 Nov 11.
• Roehrs T, Withrow D, Koshorek G, Verkler J, Bazan L, Roth T. Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo. J Clin Sleep Med. 2020 Mar 15;16(3):415-421. doi: 10.5664/jcsm.8220. Epub 2020 Jan 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Suvorexant	Small molecule	20 mg	—

Indications