Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo

Sleep. 1993 Jun;16(4):327-32. doi: 10.1093/sleep/16.4.327.


In a double-blind randomized crossover trial, oxycodone or placebo was given in divided night-time doses to 11 patients with idiopathic restless legs syndrome (RLS) for 2 weeks prior to appropriate polysomnographic studies. Under double-blinded conditions, patients were asked to do daily ratings of their leg sensations, motor restlessness and daytime alertness on a 1-4 scale for the 2 weeks prior to the polysomnographic studies and for the nights of the polysomnographic studies as well. Leg sensations (p < 0.009), motor restlessness (p < 0.006) and daytime alertness (p < 0.03) were significantly improved on oxycodone as compared to baseline or placebo. Patients were studied polysomnographically under double-blinded conditions for 2 nights in each phase of the protocol. On an average dose of 15.9 mg oxycodone (equivalent to approximately three 5-mg tablets of commercial preparation), there was a statistically significant reduction in the number of periodic limb movements in sleep [(PLMS)/hour sleep (p < 0.004)] and in the number of arousals/hour sleep (p < 0.009) on drugs as compared to baseline or placebo. A statistically significant improvement was also noted in sleep efficiency (p < 0.006) and 10 of the 11 patients preferred oxycodone over placebo. We conclude that oxycodone is an effective treatment for RLS and PLMS.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Circadian Rhythm / drug effects
  • Cross-Sectional Studies
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Oxycodone / administration & dosage
  • Oxycodone / therapeutic use*
  • Placebos
  • Polysomnography
  • Restless Legs Syndrome / drug therapy*
  • Sleep, REM / drug effects
  • Syndrome
  • Wakefulness / drug effects


  • Placebos
  • Oxycodone