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Dear Mr. Bruman: You are absolutely correct. """Patients receiving this medicine have reported falling asleep while engaged in daily living activities, including the operation of motor vehicles. Some patients have further reported that they were fully alert just prior to falling asleep and had no warning signs such as excessive drowsiness.""" If you read carefully the above statement released by the drug companies which I copied, they do indicate that patients were FULLY ALERT prior to falling asleep while engaged in daily activities. Drowsiness indeed is considered to be a separate issue from the sleep attacks. Jorge Romero ----- Original Message ----- From: "J. R. Bruman" <[log in to unmask]> To: <[log in to unmask]> Sent: Monday, July 03, 2000 6:10 PM Subject: Re: "Mirapex" scare- any info PLEASE! > I believe the term "sleep attack" common to this discussion > is a misnomer, because it sounds like merely an extension > of the "drowsiness" warning that comes with a great number > of drugs. From what I read, this is NOT "drowsiness", where > the subject feels an urge to sleep. It's a BLACKOUT, which > occurs without warning, and subject recalls nothing about it > on awakening. Something like this I think occurs in epilepsy, > but even then there is sometimes a brief warning period. The > original letter report last year implied the phenomenon was > related only to Mirapex and Requip, not to levodopa or any > other agonist. Since it seems to be rare, a careful > preliminary test should establish whether a particular > individual driver may take a particular agonist safely. > Cheers, > Joe > > > Benjamin Winter wrote: > > > > Jorge Romero reported a warning: "Patients receiving > > [Mirapex] have reported falling asleep ... " > > > > A more extensive text can be found in (1) a letter from the > > manufacturer to prescribers, and (2) in a revision of the > > FDA safety information. Those two documents [and many > > others] pop up if you go to http://www.fda.gov/search.html > > and search on Mirapex. [Many thanks to Murray Charters for > > pointing us to the FDA.] > > > > The FDA document contains the following: "some [patients] > > perceived that they had no warning signs such as excessive > > drowsiness, and believed that they were alert immediately > > prior to the event". -- So it would seem that Bob > > Armentrout's ability to detect an oncoming sleep-attack is > > not universal. > > > > The FDA document also contains the following: "In a > > fixed-dose study in early Parkinson's disease, occurrence of > > the following events increased in frequency as the dose > > increased over the range from 1.5 mg/day to 6 mg/day: > > postural hypotension, nausea, constipation, somnolence, and > > amnesia. The frequency of these events was generally 2-fold > > greater than placebo for pramipexole doses greater than 3 > > mg/day. The incidence of somnolence with pramipexole at a > > dose of 1.5 mg/day was comparable to that reported for > > placebo. ... ". -- So it would seem that Mirapex at up to > > 1.5 mg/day _may_ be 'safe' as far as sleep-attacks are > > concerned. > > > > Given our North-American dependence on cars, where most of > > us almost _cannot function_ without driving, I wonder > > whether someone is working on a 'no-doz' form of pramipexole > > or ropinirole. > > > > Ben Winter 66/66/64 > > Victoria BC Canada > > -- > J. R. Bruman (818) 789-3694 > 3527 Cody Road > Sherman Oaks, CA 91403-5013 >