Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome

Richard Allen, Philip M. Becker, Richard Bogan, Markus Schmidt, Clete A. Kushida, June M. Fry, J. Steven Poceta, David Winslow

Research output: Contribution to journalArticle

Abstract

Study Objectives: Polysomnographic study evaluating the efficacy of ropinirole for the treatment of patients with restless legs syndrome (RLS) suffering from periodic leg movements in sleep (PLMS). Design: Double-blinded, placebo-controlled, parallel-group study. Setting: 15 tertiary referral centers in the USA. Participants: 65 patients with RLS and PLMS. Interventions: Ropinirole (0.25-4.0 mg per day) or placebo for 12 weeks. Measurements and Results: Data from 59 patients were included in the primary endpoint analysis. PLMS per hour decreased more with ropinirole (48.5 to 11.8), compared with placebo (35.7 to 34.2; adjusted treatment difference: -27.2; 95% confidence interval [CI]: -39.1.-15.4; P < .0001). Periodic limb movements with arousal per hour decreased from 7.0 to 2.5 with ropinirole but increased from 4.2 to 6.0 with placebo (adjusted treatment difference: -4.3, 95% CI: -7.6.-1.1; P = .0096). Periodic limb movements while awake per hour decreased from 56.5 to 23.6 with ropinirole but increased from 46.6 to 56.1 with placebo (adjusted treatment difference: -39.5; 95% CI: -56.9.-22.1; P < .0001). Ropinirole treatment significantly improved patients' ability to initiate sleep (P < .05) and the amount of Stage 2 sleep compared with placebo (P < .001). There were also non-significant trends toward increases in total sleep time and sleep efficiency. Sleep adequacy (measured on the subjective Medical Outcomes Study sleep scale) was significantly improved with ropinirole treatment (adjusted treatment difference: 12.1; 95% CI: 1.1,23.1; P = .0316). In contrast, the placebo group showed a greater increase in Stage 3/4 sleep (P < .01). No serious adverse events occurred in either group. Conclusions: Ropinirole is effective in the treatment of both the sleep and waking symptoms of RLS.

Original languageEnglish (US)
Pages (from-to)907-914
Number of pages8
JournalSleep
Volume27
Issue number5
DOIs
StatePublished - Aug 1 2004

Keywords

  • Ekbom syndrome
  • Periodic leg movements
  • Placebo-controlled
  • Polysomnogram
  • RLS
  • Restless legs syndrome
  • Ropinirole
  • Sleep

ASJC Scopus subject areas

  • Clinical Neurology
  • Physiology (medical)

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    Allen, R., Becker, P. M., Bogan, R., Schmidt, M., Kushida, C. A., Fry, J. M., Poceta, J. S., & Winslow, D. (2004). Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome. Sleep, 27(5), 907-914. https://doi.org/10.1093/sleep/27.5.907