To investigate the effect of pregabalin on wake and sleep bout parameters.
A post hoc analysis of polysomnography data from a randomized, placebo-controlled, crossover study investigating the effect of pregabalin (150 to 450 mg/d) and placebo on sleep in fibromyalgia (FM). Eligible patients had FM and sleep-maintenance problems, including wake after sleep onset ≥45 minutes and total sleep time (TST) 3.0 to 6.5 hours, but no other sleep/circadian rhythm disorders. Polysomnography was performed for 2 consecutive nights (screening, post-treatment). Wake and sleep bout duration and frequency were derived; a “bout”=consecutive 30-s epochs of sleep or wake.
Of 119 patients randomized (103 [87%] female), data were available for 103 treated with pregabalin and 106 with placebo. Pregabalin versus placebo treatment decreased mean±SD number of wake/sleep bouts (33.24±1.33 vs. 36.85±1.32; difference: –3.61 [95% confidence interval, –6.03, –1.18]; P=0.0039) and increased sleep bout duration (15.25±0.63 vs. 11.58±0.62 min; +3.67 min [2.22, 5.12 min]; P<0.0001). Pregabalin decreased mean duration of wake bouts versus placebo (3.41±0.55 vs. 3.94±0.55 min; –0.53 min [–1.06, –0.002 min]; P=0.0493). An exploratory correlation analysis of treatment effects found stage 1 sleep was negatively correlated with wake and sleep bout duration and positively with wake/sleep bout number; slow wave sleep (%total sleep time) was positively correlated with wake and sleep bout duration and negatively with wake/sleep bout number.
Pregabalin improved sleep parameters characteristic of disturbed sleep in FM, by preventing awakenings and increasing sleep bout duration. These effects are reflected in, and correlated with, a decrease in “light sleep” (stage 1) and an increase in “deep sleep” (slow wave sleep).
*Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI
†Pfizer, New York, NY
Medical writing support was provided by Karen Burrows, MPhil, of Engage Scientific Solutions (Horsham, UK) and was funded by Pfizer (New York, NY). T.R. has received research funding and has acted as consultant or served on the Speaker’s bureau for different pharmaceutical companies including Pfizer. P.B.-B., V.W.P., and E.M.R. are employees of, and have stock options in, Pfizer.
Reprints: Thomas Roth, PhD, Sleep Disorders and Research Center, Henry Ford Health System, 2799 West Grand Boulevard, Detroit, MI 48202 (e-mail: firstname.lastname@example.org).
Received May 29, 2014
Received in revised form August 14, 2015
Accepted May 22, 2015