Dopaminergic treatment in idiopathic restless legs syndrome: effects on subjective sleepiness

Clin Neuropharmacol. Nov-Dec 2010;33(6):276-8. doi: 10.1097/WNF.0b013e3181fd82a1.


Objectives: To assess frequency and characteristics of excessive daytime sleepiness (EDS) in restless legs syndrome (RLS) and the evolution of EDS under different RLS therapies.

Methods: We analyzed data from the "Swiss RLS" study, which was conducted to compare treatment efficacy and safety of the dopamine agonist pramipexole (PPX) versus L-dopa/benserazide (L/B) in de novo patients with idiopathic RLS and performed as a randomized, double-dummy, comparative crossover trial. Primary outcome measure of the present study was the change in subjective sleepiness (as measured by Epworth sleepiness scale [ESS] score). There were 37 patients (21 women) included. Mean age was 56.6 years (range, 25-85 years), and mean body mass index was 24.6 (SD, ±3.5).

Results: At baseline, EDS (as determined by an ESS score of >10) was found in 32% of the patients. Sleepy RLS patients were younger (P < 0.001) than non-sleepy patients. Pramipexole and L/B both were effective in the treatment of RLS symptoms (IRLS score, P < 0.001 and P = 0.002). Overall, ESS was reduced (main effect for "time", P = 0.02) independent from the dopaminergic substance. In 5 of 37 patients, ESS score deteriorated to greater than 10 under treatment (PPX = 3 patients, L/B = 2 patients). No sleep attack occurred.

Conclusions: Excessive daytime sleepiness is frequent in RLS patients. Dopaminergic treatment usually promotes wakefulness, but infrequently leads to daytime sleepiness.

Trial registration: NCT00144209.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anxiety
  • Benserazide / adverse effects
  • Benserazide / therapeutic use
  • Benzothiazoles / adverse effects
  • Benzothiazoles / therapeutic use
  • Cross-Over Studies
  • Depression
  • Disorders of Excessive Somnolence / etiology*
  • Disorders of Excessive Somnolence / physiopathology
  • Dopamine Agonists / adverse effects*
  • Dopamine Agonists / therapeutic use
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Levodopa / adverse effects
  • Levodopa / therapeutic use
  • Male
  • Middle Aged
  • Pramipexole
  • Restless Legs Syndrome / complications*
  • Restless Legs Syndrome / drug therapy*
  • Severity of Illness Index
  • Sleep Stages / drug effects
  • Time Factors
  • Wakefulness / drug effects


  • Benzothiazoles
  • Dopamine Agonists
  • Drug Combinations
  • benserazide, levodopa drug combination
  • Levodopa
  • Benserazide
  • Pramipexole

Associated data