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New Approach To Fibromyalgia Tackles Poor-Quality Sleep

Thursday 19 November 2015


From Medscape Multispecialty:



New Approach to Fibromyalgia Tackles Poor-Quality Sleep

Pam Harrison
November 17, 2015

For patients with fibromyalgia, directing treatment toward nonrestorative sleep, a key feature of the syndrome, leads to improvements in other symptoms of the disease, including pain, according to two analyses of data from the phase 2b placebo-controlled BESTFIT study.

"It's been known for a long time that poor-quality sleep correlates with disease severity in patients with fibromyalgia," said Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals in New York City, who was involved in both analyses.

"We recognized that sleep wasn't only a symptom; poor sleep exacerbates the pain of fibromyalgia. It's probably a vicious cycle of poor sleep, more pain, more pain, and worse sleep," he told Medscape Medical News.

"Bedtime sublingual cyclobenzaprine hydrochloride, which targets several key receptors involved in sleep regulation, doesn't work right away, but after about 4 weeks, we are seeing an improvement in sleep quality, and after that, pain and other symptoms also improve," Dr Lederman said.

The results of the analyses were presented at the American College of Rheumatology (ACR) 2015 Annual Meeting in San Francisco.


In the BESTFIT study, patients who met the 2010 ACR criteria for fibromyalgia were randomized to sublingual cyclobenzaprine 2.8 mg taken at bedtime for 12 weeks or to placebo. Outcome measures included daily diary assessments of pain and sleep rated on a 10-point scale, the Revised Fibromyalgia Impact Questionnaire (FIQR), the Patient Global Impression of Change (PGIC) scale, and the PROMIS Sleep Disturbance scale.

Preliminary results from the study, as reported by Medscape Medical News, showed that bedtime sublingual cyclobenzaprine failed to change average daily pain scores at week 12; however, it did lead to an improvement in a number of secondary end points, including measures of sleep, effect on pain, and the overall burden of symptoms.

In contrast, the final analysis of 172 evaluable patients, presented at the meeting by Harvey Moldofsky, MD, from the Centre for Sleep and Chronobiology in Toronto, demonstrated that sublingual cyclobenzaprine has a favorable effect on both sleep and pain.

All measures of sleep quality improved with cyclobenzaprine over the 12-week study period, as did measures of pain.

The reduction in the PROMIS Sleep Disturbance score was significantly greater in the cyclobenzaprine group than in the placebo group by week 4, and this was sustained out to week 12 (8.96 vs 5.13 points; P = .005).

Reductions in the daily sleep diary score were significantly greater in the cyclobenzaprine group than in the placebo group at week 1. Significance was lost but then regained by week 6, which was sustained out to week 12 (1.85 vs 0.88 points; P < .001).

Reductions in FIQR score, an indication of improved sleep quality, were significantly greater in the cyclobenzaprine group than in the placebo group by week 2, which was sustained out to week 12 (2.9 vs 1.2 points; P < .001).

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The above originally appeared here.


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