A Task Force was established by the International Restless Legs Syndrome Study 
Group (IRLSSG) to develop evidence-based and consensus-based recommendations for 
the long-term pharmacologic treatment of restless legs syndrome/Willis-Ekbom 
disease (RLS/WED). The Task Force reviewed the results of all studies of RLS/WED 
treatments with durations of 6 months or longer presented at meetings over the 
past 2 years, posted on Web sites of pharmaceutical companies, or published in 
peer-reviewed journals, asking the questions, "What is the efficacy of this 
treatment in patients with RLS/WED?" and "What is the safety of this treatment 
in patients with RLS/WED?" The Task Force developed guidelines based on their 
review of 61 papers meeting inclusion criteria, and using a modified 
evidence-grading scheme. Pregabalin has been established as effective for up to 
1 year in treating RLS/WED (Level A evidence). Pramipexole, ropinirole, and 
rotigotine have been established as effective for up to 6 months in treating 
RLS/WED (Level A). The following drugs have been established as probably 
effective (Level B) in treating RLS/WED for durations ranging from 1 to 5 years: 
gabapentin enacarbil, pramipexole, and ropinirole (1 year); levodopa (2 years); 
and rotigotine (5 years). Because of associated safety concerns, pergolide and 
cabergoline should not be used in the treatment of RLS/WED unless the benefits 
clearly outweigh the risks. Other pharmacologic therapies have insufficient 
evidence to support their long-term use in treating RLS/WED. The IRLSSG Task 
Force also developed consensus-based strategies for the prevention and treatment 
of complications (such as augmentation, loss of efficacy, excessive daytime 
sleepiness, and impulse control disorders) that may develop with the long-term 
pharmacologic treatment of RLS/WED. The use of either a dopamine-receptor 
agonist or α2δ calcium-channel ligand is recommended as the first-line treatment 
of RLS/WED for most patients, with the choice of agent dependent on the 
patient's severity of RLS/WED symptoms, cognitive status, history, and comorbid 
conditions.