Restless Legs Syndrome: New Treatment Improves Sleep

The 12 week study involved 58 people with RLS. Of the group, 30 people received the drug pregabalin and the rest received placebo. Sleep studies were performed at the beginning and end of the research.

Researchers found nearly two-thirds of the people who took pregabalin had no RLS symptoms while taking the drug. For people who still had symptoms, those symptoms had improved by 66 percent while taking the drug, compared to the placebo group where symptoms worsened by 29 percent.

Sleep also improved for those taking pregabalin. The study showed the group spent more time in slow wave sleep, otherwise known as Stage 3 or deep sleep, and they spent less time in the lighter sleep stages known as Stage 1 or Stage 2 sleep compared to those taking placebo.

"Since RLS symptoms get worse at night, it's difficult for people with RLS to get adequate sleep," said study author Diego Garcia-Borreguero, MD, Director of the Sleep Research Institute in Madrid, Spain. "However, our findings show pregabalin helped people get more deep sleep. The drug was well tolerated and is a promising alternative to current treatments because of its superior effects on quality of sleep."

Pregabalin has been approved for epilepsy, nerve pain, generalized anxiety and fibromyalgia.

RLS is characterized by an urge to move the legs, generally accompanied by unpleasant numbness, tingling, or burning sensations; an increase in symptoms during rest and a partial, temporary relief from symptoms through activity; and a worsening of symptoms in the evening or at night. Symptoms tend to progress with age.

The study was supported by Pfizer Inc.

*The study will be presented as part of the Late-breaking Science Program at the American Academy of Neurology's 61st Annual Meeting in Seattle, April 25 – May 2, 2009.