A pilot double-blind placebo-controlled trial of low-dose pramipexole in sleep-related eating disorder

F. Provini, F. Albani, R. Vetrugno, L. Vignatelli, C. Lombardi, G. Plazzi, Pasquale Montagna

Research output: Contribution to journalArticlepeer-review


Sleep-related eating disorder (SRED) is characterized by recurrent arousals from sleep associated with compulsive ingestion of food. No controlled therapeutic trials are available for SRED. We assessed the safety, tolerability and efficacy of pramipexole, a dopamine D3-receptor agonist, in the treatment of SRED. Eleven consecutive patients with SRED in the absence of concurrent daytime eating disorders underwent actigraphic recording and subjective sleep diary evaluation for a week before and every week for 2 weeks of treatment with pramipexole 0.18-0.36 mg or placebo, administered in a double-blind crossover randomized sequence. The primary outcomes of the trial were actigraphic measures of night sleep parameters (sleep efficiency, motor activity mean and median, number and duration of wake episodes), secondary outcomes were the number of good sleep nights/weekly, number and duration of nocturnal awakenings/night, and visual analogue preference score. Pramipexole was well tolerated without any patient withdrawing from the study. Pramipexole reduced night-time activity median (P = 0.02) and increased the number of nights of good sleep/week (P = 0.02). All other measurements remained unaffected. Pramipexole at low doses was well tolerated, improving some measures of sleep quality and reducing median night activity in SRED. Further studies with higher dosages and for longer time-periods are warranted.

Original languageEnglish
Pages (from-to)432-436
Number of pages5
JournalEuropean Journal of Neurology
Issue number6
Publication statusPublished - Jun 2005


  • Actigraphy
  • Pramipexole
  • Sleep
  • Sleep-related eating disorder

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)


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