The status of rotigotine as a safe and effective alternative in the treatment of restless legs syndrome

Abstract

Restless legs syndrome (RLS) is characterized by an urge to move the legs that occurs mainly with inactivity, and it is relieved by movement and is usually worse by the end of the day. It is highly prevalent, affecting 1.9% to 4.5% of the population, and although its etiology is uncertain, genetic factors seem to be involved. When symptoms are severe enough to warrant chronic therapy, dopamine receptor agonists are to be considered for initial treatment. Rotigotine, the most recently developed drug in this category, is the only one available for transdermal delivery in RLS. It was initially designed for the treatment of Parkinson's disease. The US Food and Drug Administration approved its use in cases of moderate to severe RLS in April 2012. Its efficacy has been well established in randomized placebo-controlled trials, as it appears to be especially useful in patients with daily symptoms. The most commonly reported side effect is local skin reaction. Complications such as augmentation, somnolence, or compulsive behavior may happen, although they seldom occur. The American Academy of Sleep Medicine clinical practice guideline recommends a "Guideline Level" for rotigotine, and European RLS guidelines provide a "level A" recommendation for short-term therapy; it also was the only dopaminergic agonist considered to be effective for the long-term management of RLS.