FDA warns about 'stay awake drug' Provigil

[Rick]

I have had similar positive effects from taking Provigil for the last 1 1/2 years. I had a 45 minute drive to work and many mornings I couldn't make it without stopping for a nap. And getting excess rest and sleep during vacation and weekends didn't help. I did a sleep study that determined I was a borderline narcoleptic.
I started taking 200 mg in the morning and the results have been great. I also take 1/2 tablet (with the doctor's ok) sometimes in the afternoon if I need to be alert for something later in the day.
It has also helped with feelings of depression although I haven't been diagnosed with this.
I hope to see an endocrinologist to better understand the root cause of the sleepiness.
Cost has been rising and I just lost my job and insurance benefits. Provigil is something I will have to continue to use to maintain my quality of life.

[ziggy]

Dyscrasy wrote:

I can't LIVE without the stuff. It's SO expensive I buy it from overseas pharmacies, until it hopefully goes generic in the states. The only side effect i've ever had is, when I first started using it, I'd get a little cranky when "coming off of it". I have chronic fatigue (not the syndrome, just perpetual tiredness) so it's a necessity for me. I've turned a couple friends on to it, one's a pilot, the others a hypothyroid sufferer, and my sisters. Everyone loves it. Where I buy it (overseas) no prescription is needed.(That's the way it should be here as well) A LOT of drugs have some side effects. A fool drinking 10 bottles of cough syrup might get high, an idiot swallowing 25 Benadryl and a bottle of Excedrin might die. A couple people having hallucinations is no reason to pull a drug from the REST of us who LOVE it! I'd make a good salesperson for Provigil because I love it so. I don't know what I'd do if they pull it... Have to resort to Meth? Speed? Cocaine? Heroin? Yikes...

Can you tell me where one can obtain this med? I had it after a brain injury and it worked wonders, but was costing too much money. I also have to contend with chronic fatigue and acute chronic hypothyroidism. Can't find a doctor now who will prescribe. Is that because the FDA won't approve this drug after all? Please help, I'd like to get out of bed before I die!

[Bruce Alan]

Mike, quoted below, is almost certainly a Cephalon employee. Cephalon is the manufacturer of Provigil and also Nuvigil, the same drug under a different name. In 2006, Cephalon sought approval from the FDA to begin marketing Provigil for the treatment of ADHD ? ADD ( attention deficit disorder ) and yet another phony name, SPARLON. The FDA committee which examined the safety of Provigil / Sparlon /Nuvigil determined that mortally dangerous reactions take place 400 times more often with Provigil . The FDA turned down the petition to sell Provigil for ADHD because it was believed by the commitee on a 13 to 1 vote that Provigil was just too dangerous to have so man more people taking it.

Mike wrote:

Quick Google searching: in 2004 1.9 million prescriptions for Provigil were written in the US amounting to $414 million in sales. In 2005 prescritions for Provigil totaled $512 million.(Forbes.com on 3/13/06). How many individual patients this represents I do not know. Although the quantity has probably increased each year if at least 2 million prescriptions have been written annually since 2004 how many cases of skin rashes, hallucinations, or suicidal tendencies make up a warning from the FDA as opposed to yanking FDA approval?
I think a lot of people have a problem comprehending what large numbers represent. They can create a picture in their mind of things in smaller quantities. When they need to relate that to something beyond a certain size they seem to convert the larger quantity into some ambiguous abstraction. This results in the smaller quantity having more power and influence because the larger power is not clearly acknowledged.
A handful of people out of millions have a few adverse reactions. Even if a few die is that really significant? The greater the number of people using it the greater the chance is that someone somewhere will have a different reaction to it.
Modafinil is relatively harmless. If you hallucinate or feel like killing yourself you probably have serious problems. Modafinil wakes up neurotics and geniuses. It doesn't make you either.

[Joakim Hansson]

Provigil litterally saved my life. NO SIDE EFFECTS (except insomnia, sure it is indeed a pill for narcholepsy so that make sense..), but that fortunately goes away after a while. I also wanna add that it sure helped my depression. No sucidal thoughts nor any fuckitol thoughts... I consider it 2 b Gods gift.

[way2sleepy]

I started on Provigil 3 weeks ago. At 200mg I was still feeling tired by the end of my work day and dozing while driving home. I was increased to 300mg last week and not finding much difference in the afternoon. My Dr. said it is a once a day medication and did not give me the option of taking the 300mg in divided doses. I have tried that anyway, but then I am not as alert during the day. Any suggestions? He did say he will titrate my dosage, and will prescribe 400mg since this is the maximum daily allowance.

I take Provigil for recent diagnosis of narcolepsy, without cataplexy, after a sleep study as well as an MSLT. Sleep latency over 5 naps averaged 1.2 minutes. The fifth nap I was sleeping before the tech got to the observation room 3 doors down. Anyone else have the MSLT? that test was pure torture for me!

Would appreciate any advice from those with more experience with Provigil than myself. I do not know anyone else who takes it to ask for advice. Thank you!

[Bright Eyed Bushy Tailed]

its weird. if it was such a big problem they would have recalled it. anyway I have always found this company to be good. Never had a problem.

http://www.the-clap.com/provigil.htm

[Clear Windshield Effect]

my doctor prescribed time release amphetamines. even in the smallest dose it was too much. definitely not my type of chemical. yes i know of people who grind up several of them and seem to like it. my deal was a low level ADHD or ADD. the provigil actually did the right trick, but at low dosage, 100mg/day, taken right before the afternoon siesta urge, or around 5pm so the evening remained productive.

[Mindie Thomas]

When my Dr was telling me about Provigil he said that they approved it one day for ADHD and that afternoon a child developed Steven Johnson Syndrom and they pulled it that next morning. I take 200 first thing in the morning and then 200 at noon to help me the rest of the day. I had the horrid headaches, but that seems to have faded. I do feel a bit of a perky feeling and a bit up, but it's so much better then yawning all day and having to force myself to keep busy so I don't fall asleep on the couch. Our insurance went up so I pay $60 a month, however my perscription is over $700 a month, so I don't complain offten. I have lost weight on it but I've not had any of the other side-effects. I'm Bi-polar II with excessive sleepiness and for years we tried to control it by making me sleep at night. Finally we decided to try and keep me away. It's worked great so far.

Bruce Alan wrote:

Mike, quoted below, is almost certainly a Cephalon employee. Cephalon is the manufacturer of Provigil and also Nuvigil, the same drug under a different name. In 2006, Cephalon sought approval from the FDA to begin marketing Provigil for the treatment of ADHD ? ADD ( attention deficit disorder ) and yet another phony name, SPARLON. The FDA committee which examined the safety of Provigil / Sparlon /Nuvigil determined that mortally dangerous reactions take place 400 times more often with Provigil . The FDA turned down the petition to sell Provigil for ADHD because it was believed by the commitee on a 13 to 1 vote that Provigil was just too dangerous to have so man more people taking it.
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