The long-term treatment of restless legs syndrome/Willis-Ekbom disease: Evidence-based guidelines and clinical consensus best practice guidance: A report from the International Restless Legs Syndrome Study Group

Diego Garcia-Borreguero, Ralf Kohnen, Michael H. Silber, John W. Winkelman, Christopher J. Earley, Birgit Högl, Mauro Manconi, Jacques Montplaisir, Yuichi Inoue, Richard P. Allen

Research output: Contribution to journalArticlepeer-review

195 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)675-684
Number of pages10
JournalSleep Medicine
Volume14
Issue number7
DOIs
StatePublished - Jul 2013

Keywords

  • Calcium channel alpha 2 delta ligands
  • Dopamine agents
  • Hypnotics and sedatives
  • Opioids
  • Periodic limb movements of sleep
  • Pharmacologic therapy
  • Restless legs syndrome
  • Willis-Ekbom disease

ASJC Scopus subject areas

  • General Medicine

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