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  • Publication # 13-RA007

Certain medications are effective in reducing restless leg syndrome symptoms

Comparative Effectiveness Research

In patients with restless leg syndrome (RLS), evidence suggests that certain medications, when compared to placebo, reduce RLS symptoms and improve patient-reported sleep outcomes and quality of life, according to a new research review by AHRQ’s Effective Health Care Program. These medications include dopamine agonists (pramipexole, rotigotine, ropinirole and cabergoline) and anticonvulsant alpha-2-delta ligands (gabapentin enacarbil, gabapentin, and pregabalin). However, these drugs may not work in all patients, since short- and long-term negative side effects, treatment withdrawals, and lack of effectiveness are common. RLS is a neurological disorder characterized by unpleasant sensations in the legs and a distressing, irresistible urge to move one’s body. RLS can result in reduced quality of life and negatively impact sleep, leading to daytime fatigue. Most research on RLS treatments is limited to short-term studies of dopamine agonists and alpha-2-delta ligands in adults with moderate to very severe primary RLS of long duration.

Evidence is lacking on long-term drug effectiveness and whether these results apply to adults with less severe or less frequent RLS symptoms, children, or individuals with secondary RLS, including those with iron deficiency, end-stage renal disease, or pregnant women or those intending to become pregnant. No high-quality data was found on the comparative effectiveness and risks of commonly used treatments and non-drug interventions such as exercise, limb massage, hot or cold baths, avoiding caffeine and alcohol, acupuncture, or cognitive behavioral therapy; or the effect of patient or RLS characteristics on outcomes. More research is needed to determine whether treatment benefits observed in short-term studies are maintained, and whether the therapies are tolerated long term. These findings can be found in the research review Treatments for Restless Legs Syndrome. This and other reviews can be found on AHRQ’s Effective Health Care Program Web site at

Page last reviewed April 2013
Internet Citation: Certain medications are effective in reducing restless leg syndrome symptoms: Comparative Effectiveness Research. April 2013. Agency for Healthcare Research and Quality, Rockville, MD.


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