Translated from Rev Prescrire May 2013; 33 (355): 351 Piribedil: sleep attacks, also in patients without Parkinson’s disease

 Piribedil is a dopamine agonist used According to the definition adopted in drug having a direct role in sleep attacks, in Parkinson’s disease and a variety of this study, sleep attacks are “events of and probably a similar role to that of other clinical situations although its overwhelming sleepiness that occur with- other dopamine agonists. efficacy has not been demonstrated. out warning or with a prodrome suffi- ciently short or overpowering to prevent In practice: piribedil has little value.  A study based on the French nation- protective measures” (7). Piribedil has not been shown to be an al pharmacovigilance database iden- The French pharmacovigilance data- effective treatment for vascular disorders. tified and analysed 7 reports of sleep base contained 7 reports of sleep attacks It is not the first-choice dopamine agonist attacks attributed to piribedil in that met this definition in patients without in Parkinson’s disease, and its value is patients without Parkinson’s disease. Parkinson’s disease who were taking unclear (1,3,8). Unnecessary exposure of The case reports are detailed and indi- piribedil. The average age of these patients to the adverse effects of piribedil cate that piribedil has a direct role in 7 patients was 69 years. The daily dose is not justified. It is better to use drugs with the onset of sleep attacks. ranged from 20 mg to 150 mg (median: demonstrated efficacy instead. 50 mg). Six patients were using piribedil ©Prescrire  To spare patients unnecessary for a variety of vascular disorders, and the exposure to the adverse effects of other patient was taking it for essential a- The main adverse effects of dopamine agonists are: gas- piribedil, it is better to avoid using tremor. In 6 cases, piribedil was the only trointestinal disorders; hypotension, particularly orthosta- piribedil tic hypotension; and mental disorders (confusion, and to choose drugs with drug implicated (7). hallucinations, delusions, psychomotor agitation, patho- demonstrated efficacy instead. In 5 cases, the sleep attacks began logical gambling and hypersexuality) (ref 1). Rev Prescrire 2013; 33 (355): 351. within 3 days of taking the first dose. In piribedil one woman who had taken for Selected references from Prescrire’s literature 10 years with 2 interruptions, the sleep search. 1- iribedil is a dopamine agonist used attacks stopped after each discontinuation Prescrire Rédaction “12-4-4. Patients sous ago- P niste dopaminergique” Rev Prescrire 2012; 32 to treat Parkinson’s disease, but its and recurred each time the drug was (350 suppl. interactions médicamenteuses). efficacy is less well evaluated than that of reintroduced (7). 2- ANSM “RCP-Trivastal 50 mg LP + 20 mg com- primés” 21 December 2011: 10 pages. other dopamine agonists (1,2). It is also 3- Prescrire Rédaction “Les indications des médica- authorised in France as a “vasodilator” to Road traffic accidents, falls. Four ments dits “vasoactifs” en ophtalmologie. Le flou treat certain types of chronic cognitive and patients experienced sleep attacks while organisé” Rev Prescrire 2002; 22 (228): 330-331. 4- Prescrire Rédaction “Vasodilatateurs toujours neurosensory deficits in elderly patients, working or driving. One 56-year-old man remboursables” Rev Prescrire 2005; 25 (258): 99. intermittent claudication caused by chron- was admitted to hospital following sleep 5- ANSM “Commission d’AMM du 12 juillet 2012. Verbatim” 10 October 2012: 45 pages. ic peripheral artery occlusive disease, attacks that occurred two hours after his 6- Prescrire Rédaction “Accès soudains de sommeil and in ophthalmology, although its efficacy second dose of piribedil. One 75-year-old et antiparkinsoniens” Rev Prescrire 2004; 24 (256): in these indications has not been demon- man had an initial sleep attack while he 834-835. 7- Gouraud A et al. “Piribedil-induced sleep attacks strated (2-5). was driving, one hour after taking his in patients without Parkinson disease: a case series” Piribedil exposes patients to the first dose of piribedil. He felt the need to Clin Neuropharmacol 2011; 34 (3): 104-107. adverse effects of dopamine agonists, stop for a 10-minute nap. He had two 8- Prescrire Rédaction “Traitement de la maladie de Parkinson. Première partie: d’abord une monothé- including sudden sleep attacks, most of more attacks after resuming his journey, rapie par lévodopa ou agoniste dopaminergique” Rev which have been reported in patients the second of which caused a road traf- Prescrire 2011; 31 (329): 200-205. with Parkinson’s disease (a)(1,6). Does fic accident. One 86-year-old man taking this adverse effect also occur when piribedil for peripheral vascular disorders piribedil is used for other disorders, by had two falls caused by sleep attacks. The patients without Parkinson’s disease? A patients described these sleep attacks as case series published in 2011 provides intense and sudden. In all cases, the some answers to this question. sleep disorders resolved after discontin- uation of piribedil (7). Sudden sleep attacks, from the first few days of treatment. A group from the A direct role for piribedil. Sleep Lyon Regional Pharmacovigilance Cen- attacks are a known adverse effect of tre searched the French national phar- dopamine agonists. As most of the data macovigilance database for reports of came from patients with Parkinson’s dis- sleep attacks attributed to piribedil in ease, uncertainty remained over the role patients without Parkinson’s disease, of the disease in these sleep disorders (6). recorded between January 1988 and These case reports, in patients taking December 2008 (7). piribedil but who did not have Parkin- son’s disease, are consistent with this

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