approved by the FDA for management of fibromyalgia. It is used to
relieve neuropathic pain (pain from damaged nerves) that can occur in
your arms, hands, fingers, legs, feet, or toes if you have diabetes or
in the area of your rash if you have had shingles (a painful rash that
occurs after infection with herpes zoster) as well as fibromyalgia.
Arthritis Care Res (Hoboken). 2012 Jan 9. doi: 10.1002/acr.21595.
[Epub ahead of print]
Effect of pregabalin on sleep in patients with fibromyalgia and sleep
maintenance disturbance: A randomized, placebo-controlled, 2-way
crossover polysomnography study.
Roth T, Lankford DA, Bhadra P, Whalen E, Resnick EM.
Sleep Disorders and Research Center, Henry Ford Health System,
To assess the effect of pregabalin on polysomnographic (PSG) measures
of sleep, and patient-rated sleep, tiredness, and pain in fibromyalgia
Randomized, double-blind, placebo-controlled, 2-period crossover PSG
study. Patients ≥18y with fibromyalgia satisfied subjective and
objective sleep disturbance criteria prior to randomization. Eligible
patients were randomized (1:1) to pregabalin (300-450mg/day) or
placebo for crossover Period 1; and vice versa for Period 2.
Each crossover period comprised a dose-adjustment and dose-maintenance
phase, with a 2-week taper/washout between periods. In-laboratory PSGs
were recorded during 2 consecutive nights at screening and the end of
each crossover period.
The primary endpoint was difference in sleep maintenance defined by
PSG-recorded wake-after-sleep-onset (WASO; minutes) between 4-weeks'
treatment with pregabalin and with placebo. Other PSG measures,
patient-rated sleep, tiredness, and pain, and tolerability were
Of 119 patients randomized (103[86.6%] female; 48.4y), 102(85.7%)
completed both periods. Treatment with pregabalin showed a reduction
in PSG-determined WASO versus treatment with placebo (Week 4
difference [95% confidence interval]:-19.2[-26.7 to
Pain score improved (reduced) with pregabalin versus placebo treatment
at all 4 weeks (Week 4 difference:-0.52[-0.90 to -0.14];P=0.008).
Modest (rho<0.3) but significant correlations were found between PSG
sleep assessments and ratings of pain and sleep quality.
Frequently reported adverse events (pregabalin vs. placebo) were:
dizziness (30.4% vs. 9.9%), somnolence (20.5% vs. 4.5%), and headache
(8.9% vs. 8.1%).
Patients with fibromyalgia treated with pregabalin had
statistically-significant and meaningful improvements in sleep, as
assessed by PSG. Patients with fibromyalgia also reported reduced
daily pain. Pregabalin was well tolerated.
© 2012 by the American College of Rheumatology.
PMID: 22232085 [PubMed - as supplied by publisher]