Long-term treatment with pramipexole in restless legs syndrome

Eur J Neurol. 2006 Dec;13(12):1306-11. doi: 10.1111/j.1468-1331.2006.01459.x.


The aim of the present study was to look at the long-term efficacy and side effects profiles of pramipexole in a large cohort of drug naïve patients with regard to dopaminergic medications. In all, 195 consecutive restless legs syndrome (RLS) patients who were prescribed pramipexole more than 1 year previously, agreed to undergo a telephone interview to assess both the efficacy and side effects of pramipexole. Forty-three patients had discontinued pramipexole: 20 because of side effects, six because of a lack of efficacy, six for both and 11 for other reasons. Patients who continued pramipexole for more than 1 year (n = 152) reported a mean decrease in RLS symptoms severity of 80.9% (SD = 19.6%). At the onset of treatment, the most common side effects were nausea (30%), tiredness (9%), dizziness (8%), headache (4%), insomnia (3%), dry mouth (2%), difficulty to concentrate (1.3%) and sleepiness (0.7%), At 30 months, most patients (n = 124/152; 81.6%) reported an absence of side effects of pramipexole. None of the adverse effects occurred in more than 5% of patients at follow-up. The present study confirms, in a large cohort of unselected patients, that pramipexole is effective and safe in the long-term treatment of RLS.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age of Onset
  • Aged
  • Antiparkinson Agents / adverse effects
  • Antiparkinson Agents / therapeutic use*
  • Benzothiazoles / adverse effects
  • Benzothiazoles / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Dropouts / statistics & numerical data
  • Pramipexole
  • Restless Legs Syndrome / diagnosis
  • Restless Legs Syndrome / drug therapy*
  • Retrospective Studies
  • Treatment Outcome


  • Antiparkinson Agents
  • Benzothiazoles
  • Pramipexole