A double-blind randomized crossover trial of bromocriptine and placebo in restless legs syndrome

Ann Neurol. 1988 Sep;24(3):455-8. doi: 10.1002/ana.410240318.


A double-blind randomized crossover study of 7.5 mg bromocriptine at bedtime versus placebo was conducted in 30-day phases (with a 2-week washout period between phases) in 6 patients with idiopathic restless legs syndrome. Five patients experienced partial subjective improvement in restlessness and paresthesias on bromocriptine as opposed to placebo and expressed a desire to continue on the medication. On bromocriptine, the patients showed polysomnographically a mean decrease of 43% from control and a mean decrease of 57% from placebo in the number of periodic movements of sleep per hour of sleep (p less than 0.025). Two of 3 patients with abnormally decreased total sleep time and sleep efficiency showed an improvement in these measures on therapy. The dopamine agonist bromocriptine may be a useful therapy in some patients with restless legs syndrome.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bromocriptine / therapeutic use*
  • Clinical Trials as Topic
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Random Allocation
  • Restless Legs Syndrome / drug therapy*
  • Restless Legs Syndrome / physiopathology
  • Sleep / drug effects
  • Sleep / physiology


  • Placebos
  • Bromocriptine