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Randomised controlled trial
Pregabalin is more effective than placebo for restless legs syndrome with mild adverse effects of daytime somnolence, headache and unsteadiness
  1. Mark J Buchfuhrer1,2
  1. 1SomnoMedix Sleep Disorders Center, Lakewood, California, USA
  2. 2Downey Regional Medical Center, Downey, California, USA
  1. Correspondence to Mark J Buchfuhrer
    11480 Brookshire Avenue, Suite 108, Downey, CA 90241, USA; mark.jb{at}

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Restless legs syndrome (RLS) is a common sensorimotor neurological disorder that affects 5–10% of the adult population of western countries. The majority of these patients are now being treated by primary care physicians rather than by specialists. The only drugs currently approved to treat RLS are levodopa (in Europe) and the dopamine agonists (DAs) pramipexole and ropinirole (in Europe and North America). This leaves a large clinical void when patients do not respond to or tolerate DAs. Furthermore, with time, some patients become tolerant to treatment with DAs while others (up to 30% in some studies) may develop augmentation (RLS symptoms become more severe, occur earlier in the day and spread to other body parts after months of treatment with DAs).

There is clearly a substantial need for alternative types of approved therapies for RLS. Numerous studies have demonstrated that gabapentin and its prodrug, gabapentin enacarbil are effective for treating RLS. Therefore, other α2δ ligands of the voltage-dependent calcium channel such as pregabalin may be valuable for treating RLS. In addition, RLS patients have considerable problems with insomnia …

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  • Competing interests MJB has received lecture or consultant fees from Pfizer, GSK, Xenoport, UCB, Cephalon, Sepracor, Boehringer-Ingelheim, Sanofi-Aventis and Schering.