Treatment with pregabalin significantly improved sleep and pain in patients with fibromyalgia, according to research presented at the 63rd annual meeting of the American Academy of Neurology, in Honolulu (S27.003).

According to the researchers the improvement in total sleep time was comparable to that seen with standard, FDA-approved sleep-promoting agents such as zolpidem [Ambien, Sanofi-aventis] or eszopiclone [Lunesta, Sunovion Pharmaceuticals],

The researchers enrolled 119 patients, 103 of who were women, to treatment with pregabalin (300-450 mg per day) or placebo in a randomized double-blind fashion. Patients had a mean age of 48.4 years. Dose adjustment took place in the first 14 days, followed by maintenance dosing until day 29. After a two-week taper and washout period, patients repeated the protocol in the other study arm.

The investigators found that pregabalin improved two important sleep parameters: It reduced wake after sleep onset by 19.2 minutes compared with placebo (P<0.0001) and increased total sleep time by more than 25 minutes compared with placebo (396.2 vs. 370.6 min; P<0.0001). Additionally, pregabalin lowered pain scores compared with placebo (P=0.008).

Several adverse events were more common in patients who received pregabalin versus placebo, including dizziness (30.4% vs. 9.9%), headache (8.9% vs. 8.1%) and somnolence (20.5% vs. 4.5%).

With respect to the mechanism of action of pregabalin in improving sleep, Antonio Culebras, MD, who was not involved in the study, hypothesized that it is likely multifactorial. “According to the results of Dr. Roth’s study, pregabalin reduces fragmentation of nocturnal sleep and consolidates nocturnal sleep. Although these phenomena may be the result of pain reduction, a direct effect of pregabalin on sleep cannot be ruled out,” said Dr. Culebras, professor of neurology, Upstate Medical University, Syracuse, N.Y., and a fellow of the American Academy of Neurology.

In addition to having a direct effect on sleep, the drug may have reduced periodic limb movements in sleep, which causes arousals that increase fragmentation of nocturnal sleep. Dr. Culebras recommended that physicians consider conducting a sleep study in patients with fibromyalgia who complain of incapacitating or unsafe excessive daytime sleepiness, decreased work productivity or motor vehicle accidents.

“It is important to optimize sleep in patients with fibromyalgia, as improved sleep results in decreased pain, but we should start with improving sleep hygiene and exercise, and limiting caffeine, and usually reserve sleep studies for patients with symptoms that suggest parasomnias or sleep apnea,” said Jan Brandes, MD, assistant clinical professor of neurology at Vanderbilt University School of Medicine, Nashville, Tenn., who also was not involved in the study.

Dr. Brandes added, “In clinical practice, our top four drugs for treating chronic migraine are pregabalin, nortriptyline, topiramate, and valproate. If a patient has both chronic migraine and fibromyalgia, pregabalin would be my first choice. However, fibromyalgia is such a poorly understood disorder, pregabalin may even have different mechanisms of action in different subsets of fibromyalgia patients.”

Source: LifeandPain.Com

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