Patients with fibromyalgia syndrome (FMS) who were treated with pregabalin in a polysomnography (PSG) study had statistically significant and meaningful improvements in sleep and reported decreased daily pain. The drug was well tolerated.
Researchers at the Sleep Disorders and Research Center in the Henry Ford Health System in Detroit performed a 2-period crossover study of patients with FMS aged 18 years and older to assess the effect of pregabalin on PSG measures of sleep and patient-rated sleep, tiredness, and pain. The patients were randomized to pregabalin (300 to 450 mg/d) or placebo for the first crossover period and vice versa for the second. Each period included a dose-adjustment and dose-maintenance phase; there was a 2-week taper/washout between them. In-laboratory PSGs were recorded during 2 consecutive nights at screening and at the end of each crossover period. The primary end point was the difference in sleep maintenance defined by PSG-recorded wake after sleep onset (WASO) between the groups after 4 weeks of treatment.
The patients treated with pregabalin showed a 19.2-minute reduction in PSG-determined WASO versus treatment with placebo after 4 weeks. The pain score improved with pregabalin versus placebo treatment at all 4 weeks. Modest but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. The study article, "Effect of Pregabalin on Sleep in Patients with Fibromyalgia and Sleep Maintenance Disturbance: A Randomized, Placebo-Controlled, 2-Way Crossover Polysomnography Study," appears in the April issue of Arthritis Care & Research.