New Drug for Restless Legs Syndrome
FDA Patient Safety News: Show #42, August 2005

The FDA recently approved a drug called Requip (ropinorole) to treat moderate to severe restless legs syndrome (RLS), a neurologic disorder characterized by uncomfortable sensations in the legs that appear at rest, usually at night, and that induces a strong desire to move the legs. This can result in chronic insomnia and sleep deprivation. Requip is manufactured by GlaxoSmithKline. The drug is a dopamine agonist and it was first approved in 1997 to treat Parkinson's disease.

Requip was found to be effective in treating RLS in three randomized, double-blind, placebo-controlled studies. The label for the drug will caution that Requip can have sedating effects, and that syncope and symptomatic hypotension can occur, especially during initial treatment.

Additional Information:

FDA Talk Paper - FDA Approves Requip for Restless Legs Syndrome.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01356.html