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Hi Dick & Margie and All, This subject was discussed at length about a year and a half ago... ‘Sleep Attacks’ from Drugs? Parkinson’s Treatment Led to Car Accidents By Lauran Neergaard - The Associated Press W A S H I N G T O N, June 9, 1999 — Two new drugs for Parkinson’s disease may suddenly put patients to sleep, a dangerous narcolepsy-like side effect termed “sleep attack” that has caused at least eight people to have car wrecks, doctors warned today. http://www.abcnews.go.com/sections/living/DailyNews/parkinsonsdrug s990609.html Detroit News (same story but this link won't *wrap* on you) http://detnews.com/1999/health/9906/11/06100194.htm The 2 drugs cited in the news story were mirapex and requip... This is the study that launched the press releases... Neurology 1999 Jun 10;52(9):1908-10 Falling asleep at the wheel: motor vehicle mishaps in persons taking pramipexole and ropinirole. Frucht S, Rogers JD, Greene PE, Gordon MF, Fahn S Columbia-Presbyterian Medical Center, New York, NY, USA. The authors report a new side effect of the dopamine agonists pramipexole and ropinirole: sudden irresistible attacks of sleep. Eight PD patients taking pramipexole and one taking ropinirole fell asleep while driving, causing accidents. Five experienced no warning before falling asleep. The attacks ceased when the drugs were stopped. Neurologists who prescribe these drugs and patients who take them should be aware of this possible side effect. PMID: 10371546, UI: 99297956 http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=Pu bMed&list_uids=10371546&dopt=Abstract Narcolepsy-like Side Effect The FDA is considering requiring the manufacturers of two new drugs for Parkinson’s disease to add an additional warning to their labeling after reports of a dangerous side effect called "sleep attack." Sudden feelings of overwhelming and irresistible sleepiness have occurred in at least 12 patients receiving Pharmacia & Upjohn’s Mirapex (pramiprexole) and SmithKline Beecham’s Requip (ropinirole), resulting in eight car accidents and four "sleep attacks" during business meetings and phone calls. Manufacturers are currently investigating whether these medications specifically caused the attacks or whether patient condition or drug interactions may be at fault. Both medications were approved in 1997 for the treatment of muscle rigidity, tremors and difficulty moving associated with Parkinson’s disease. Caution patients not to stop taking their medications unless advised to do so by their physician. Drug Facts and Comparisons News July 99 http://pswi.org/ltc/summer99/briefs.htm in Canada... College of Physicians and Surgeons of BC Fall 1999 Warning Sudden onset of sleep in patients taking Mirapex (pramipexole) was the subject of a Dear Health Care Professional letter issued in July. Unlike typical drug-related sedation, patients taking Mirapex often had no warning that they were about to fall asleep. Car accidents have been recorded; tell patients to avoid hazardous activities that require mental alertness, such as driving a car, while taking Mirapex. The Canadian ADR Monitoring Program has received a report of a sudden sleep attack associated with another dopamine agonist, Requip (ropinirole). http://www.cpsbc.bc.ca/physician/quarterly/26.htm Who are the ADR? Adverse Drug Reactions - New ADR Telephone Number The telephone number for the BC Regional ADR Centre has just changed to 806-8625. Both health professionals and patients can call this line to report a suspected adverse drug reaction and to ask if we know of previous reports of specific reactions in BC, Canada or reported to the WHO ADR Monitoring Program. They are also accessible by fax (604) 806-8262 and e-mail [log in to unmask] in Germany... Nervenarzt 2000 Aug;71(8):670-6 ["Sleep attacks" in Parkinson patients. A side effect of nonergoline dopamine agonists or a class effect of dopamine agonists]? [Article in German] Moller JC, Stiasny K, Cassel W, Peter JH, Kruger HP, Oertel WH Klinik fur Neurologie, Philipps-Universitat Marburg. Recently, sudden "sleep attacks" have been described in parkinsonian patients taking the nonergoline dopamine agonists pramipexole and ropinirole. Due to this possible side effect, patients must be instructed not to drive vehicles and to refrain from other activities carrying the risk of self-injury. However, the very existence of sleep attacks remains controversial in sleep medicine, since a gradual transition from wakefulness to sleep is normally observed. Accordingly, sudden onset of sleep, e.g., in narcolepsy or sleep apnea syndrome, is usually associated with excessive daytime sleepiness. Prevalence of sleep disorders and daytime sleepiness have been shown to be increased in Parkinson's disease. Nonergoline dopamine agonists are already known to induce somnolence. Currently, it is not predictable whether sleep attacks represent a sudden transition from wakefulness to sleep or result from an increased propensity to fall asleep, with patients perceiving a sudden onset. Possible pathophysiological mechanisms and legal implications of sleep attacks are discussed. PMID: 10996919, UI: 20451472 in the US.... Mov Disord 2000 Jul;15(4):658-63 Pramipexole-induced somnolence and episodes of daytime sleep. Hauser RA, Gauger L, Anderson WM, Zesiewicz TA Department of Neurology, University of South Florida, Tampa General Hospital, USA. [Medline record in process] Pramipexole is a non-ergot dopamine agonist used to treat Parkinson's disease (PD). Because of concern regarding driving safety, we evaluated the incidence and nature of somnolence experienced by patients receiving pramipexole in clinical trials at our center. A retrospective chart review was performed and structured interviews were conducted with patients who had reported moderate or severe somnolence. In addition, two patients underwent polysomnography (PSG) and multiple sleep latency tests (MSLT) while on and 2 weeks after discontinuation of pramipexole. Forty patients with PD participating in pramipexole clinical trials were identified. In the double-blind phases of the studies, 22 patients were randomized to pramipexole and 18 were randomized to placebo. Six patients assigned to pramipexole reported somnolence as an adverse event (1 moderate, 5 mild) compared with two patients assigned to placebo (1 severe, 1 moderate; p = 0.19, one-tailed Fisher's exact test). Thirty-seven patients participated in open-label extension studies. Twenty-one (57%) reported somnolence as an adverse event. Eleven (30%) patients reported moderate somnolence and three (8%) patients reported severe somnolence. For patients with moderate or severe somnolence, the onset of worst-reported somnolence occurred at a mean (+/- standard error) pramipexole dose of 4.0 +/- 0.4 mg (range, 0.75-4.5 mg) per day. Patients had been taking pramipexole for a total of 10.0 +/- 1.5 months (range, .03-22 mos) and at their maximal dose for 6.7 +/- 1.5 months (range, .03-20 mos). During structured interviews with 12 of the 14 patients reporting moderate or severe somnolence, seven reported falling asleep while driving and two reported minor motor vehicle accidents caused by falling asleep. Most patients reported relatively continuous drowsiness that led to falling asleep without acute warning during periods of inactivity. Three patients reported discreet waves of irresistible sleepiness heralded by prodromal symptoms occurring against a background of normal wakefulness. MSLT in two of these patients revealed decreased latency to sleep without early onset of rapid eye movements. Sleep latency normalized after withdrawal of pramipexole. Intensive patient education is necessary to prevent motor vehicle accidents in patients taking pramipexole. We recommend that patients who are experiencing generalized drowsiness and falling asleep during periods of inactivity be instructed not to drive because these patients do fall asleep without acute warning. Somnolence usually resolves with pramipexole dose reduction or discontinuation. Patients should also be alerted to pull over and stop driving immediately if they feel a wave of sleepiness coming on. Patient education and compliance are critical to maximize safety. PMID: 10928575, UI: 20382319 and around the World ... with or without PD... Accid Anal Prev 1999 Nov;31(6):639-49 Road accidents caused by drivers falling asleep. Sagberg F Institute of Transport Economics, Oslo, Norway. [log in to unmask] About 29600 Norwegian accident-involved drivers received a questionnaire about the last accident reported to their insurance company. About 9200 drivers (31%) returned the questionnaire. The questionnaire contained questions about sleep or fatigue as contributing factors to the accident. In addition, the drivers reported whether or not they had fallen asleep some time whilst driving. and what the consequences had been. Sleep or drowsiness was a contributing factor in 3.9% of all accidents, as reported by drivers who were at fault for the accident. This factor was strongly over-represented in night-time accidents (18.6%), in running-off-the-road accidents (8.3%), accidents after driving more than 150 km on one trip (8.1%), and personal injury accidents (7.3%). A logistic regression analysis showed that the following additional factors made significant and independent contributions to increasing the odds of sleep involvement in an accident: dry road, high speed limit, driving one's own car, not driving the car daily, high education, and few years of driving experience. More male than female drivers were involved in sleep-related accidents, but this seems largely to be explained by males driving relatively more than females on roads with high speed limits. A total of 10% of male drivers and 4% of females reported to have fallen asleep while driving during the last 12 months. A total of 4% of these events resulted in an accident. The most frequent consequence of falling asleep--amounting to more than 40% of the reported incidents--was crossing of the right edge-line before awaking, whereas crossing of the centreline was reported by 16%. Drivers' lack of awareness of important precursors of falling asleep- -like highway hypnosis, driving without awareness, and similar phenomena--as well as a reluctance to discontinue driving despite feeling tired are pointed out as likely contributors to sleep-related accidents. More knowledge about the drivers' experiences immediately preceding such accidents may give a better background for implementing effective driver warning systems and other countermeasures. PMID: 10487339, UI: 99415261 This from the National Parkinson Foundation & Dr. Lieberman... "Sleep Attacks: Sudden Episodes of Falling Asleep Without Warning, Without Being Drowsy, Or Falling Asleep Without Remembering You Were Drowsy?" by Abraham Lieberman MD http://www.parkinson.org/sleepreq.htm Another opinion - Dr. Stacey... AH Moderator: My husband is newly diagnosed with PD and is taking Mirapex, which makes him a little drowsy. We've heard about falling asleep at the wheel - does he need to stop driving? Should we consider another dopamine agonist? Dr. M Stacy: Recently there was a report at a scientific meeting that found an increased frequency of sleep attacks in several patients on Mirapex and one patient on ReQuip. While excessive sleepiness is a concern with almost all anti-PD medications, the occurrence of a sudden sleep attack poses a potential personal and public safety risk. In your case, since your husband reports sleepiness on Mirapex, I believe it is reasonable to try Permax or ReQuip. However, in general, I believe that Mirapex, Permax, and ReQuip are very well tolerated. These do not usually require any adjustment in patients doing well. I have not advised my patients to discontinue driving when starting a dopamine agonist but it is important to know of this potential problem. http://www.wemove.org/par_pdwc9_30_99.html and - PDF & Dr. Stanley Fahn... Risk of "sleep attacks" with some PD medications prompts stern warning from PDF http://www.pdf.org/news/index.cfm?fuseaction=details&selectedItem=32 What the Pharmacists say...... Warning on Parkinson`s drugs An important finding about Mirapex® (pramipexole) and Requip® (ropinirole) Doctors have noted that a small number of patients who take these drugs have had "sleep attacks", sudden and overpowering feelings of intense fatigue. Some of these attacks have led to automobile accidents. If you take Mirapex or Requip, ask your doctor for more details about these findings. The risk of sleep attack is very low, but you should be aware of the possibility. http://www.rpspharmacy.com/nl/warningOnParkinson.asp The FDA and Safety Alert... SafetyAlerts September 22, 1999 FDA Posts Warning of Parkinson's Drug Causing Patients to Unexpectedly Sleep - Even While Driving http://www.safetyalerts.com/t/g/mirapex.htm The bottom line in all of this - Due to this possible side effect, patients must be instructed not to drive vehicles and to refrain from other activities carrying the risk of self- injury. Thus Dr. Bob Finks caution.... Best regards .......... murray On 17 Dec 2000, at 18:15, Dick Swindler wrote: > Bob - > > I'm a bit unclear as to how you intend your caution about Mirapex to be > read. > Is it your position that no one should try Mirapex because of possible > sleep > attacks, or are you suggesting that it should be tried with caution? I > don't know if there are any studies suggestion that if one hasn't > experienced a sleep attack after X number of weeks or months on the > drug, then one isn't likely to experience them at all. It would be > interesting to know. > > After two-plus years of Dick's taking Mirapex with extremely positive > results and no problems, ever, with sleepiness or sleep attacks, it > seems to me that we can feel comfortable that the problem isn't going to > arise. > > Margie ********************* [log in to unmask]