Effect of pramipexole in treatment of resistant restless legs syndrome

Mayo Clin Proc. 1998 Jun;73(6):497-500. doi: 10.4065/73.6.497.


Objective: To report the results of an open-label trial with a dopaminergic agent, pramipexole, in patients with treatment-resistant restless legs syndrome (RLS).

Material and methods: We studied the response to pramipexole in a consecutive series of 16 patients with symptomatic RLS who had previously experienced failure with other dopaminergic therapies. Patients assessed their posttreatment change in symptoms of RLS on a visual analog scale and indicated drug-related side effects with use of a checklist.

Results: With a mean dose of pramipexole of 0.3 mg, most patients reported clinically significant improvement. From 2 to 3 months after initiation of pramipexole therapy, nocturnal leg restlessness, involuntary leg movements, and insomnia had decreased in 12, 10, and 11 patients, respectively. The most frequent adverse effects were fatigue and stiffness, which occurred in a third of the patients. Overall, the drug was well tolerated.

Conclusion: On the basis of these findings, we propose that pramipexole, a D2 subgroup receptor agonist, is an effective agent for treatment of RLS.

MeSH terms

  • Adult
  • Aged
  • Benzothiazoles
  • Dopamine Agents / adverse effects
  • Dopamine Agents / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neurologic Examination / drug effects
  • Patient Satisfaction
  • Polysomnography
  • Pramipexole
  • Restless Legs Syndrome / drug therapy*
  • Restless Legs Syndrome / etiology
  • Sleep Stages / drug effects
  • Thiazoles / adverse effects
  • Thiazoles / therapeutic use*
  • Treatment Outcome


  • Benzothiazoles
  • Dopamine Agents
  • Thiazoles
  • Pramipexole