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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by J. Lester on December 9, 2000, at 21:42:12
Hello all :What I found on the net is really disturbing.
I found that Modafinil is controlled in the US ...
See the price list at www.antiaging-systems.comIs it true ?
J.L.
Posted by mr. man on December 9, 2000, at 22:55:09
In reply to Modafinil is a controlled substance !!!, posted by J. Lester on December 9, 2000, at 21:42:12
it is a schedule 4 controlled substance, I dont think that makes it illegal though, the main problem is price, from the IAS site it would cost $1800 to $3600 a year! thats crazy!
Posted by Rick on December 13, 2000, at 4:53:23
In reply to Re: Modafinil is a controlled substance !!!, posted by mr. man on December 9, 2000, at 22:55:09
> it is a schedule 4 controlled substance, I dont think that makes it illegal though, the main problem is price, from the IAS site it would cost $1800 to $3600 a year! thats crazy!
> it is a schedule 4 controlled substance, I dont think that makes it illegal though, the main problem is price, from the IAS site it would cost $1800 to $3600 a year! thats crazy!.----
For perspective on the controlled substance count, the old pain standby Tylenol w/Codeine is in a more tightly controlled class (3), and Ritalin is in a *much* more tightly controlled class (2). It's hard to understand why the FDA designated Provigil a controlled substance at all. Although I'm not positive, I believe neither France nor England place Provigil in a controlled class. I think the reasons for control in the U.S. are:-- Concern that some people will abuse it by taking it late to stay awake when they should be getting sleep.
-- Lingering thought that Provigil must have some abuse potential simply because the traditional, amphetamine-based stimulants do.
-- So that importer Cephalon could get quicker approval for the drug.
-- Because Cephalon is relatively small and doesn't have the resources and clout to fight any unfounded FDA concerns. I always think it's interesting that a med like Provigil, which research shows rarely causes withdrawal problems is controlled, when a non-controlled AD like Paxil causes many people to experience major withdrawal difficulties. If Provigil were imported by giant Smith Kline Beecham instead of little Cephalon, I think it's very likely it would not have ended up with a controlled designation. (Fyi, I stopped Provigil cold turkey for one week with no physical effects except a little more fatigue, and some mild loss of the therapeutic benefits of my Klonopin/Serzone/Provigil combo. Again, maybe it's the fear that some people will use Provigil as a way to purposely avoid sleeping. (By the way, it does not usually cause insomnia if taken as intended. Provigil helps me stay awake and alert when I want to be, but doesn't interfere with my sleep in the least -- even the occasional daytime nap.)
Regarding the expense, Cephalon is (or at least was) offering some kind of financial assistance.
But I never read the details...maybe you have to be diagnosed with narcolepsy, which is the only official FDA-approved use thus far (even though it is used for other disorders half the time). Check out www.provigil.com. for info on the financial assistance, it it's stil being offered.Also, regarding cost, most of the time I use only 100 mg/day -- half of the typical recommended dose of 200mg. I get 200 mg tablets which are easy to snap in half with your hands. Depending on the curent prices and/or insurance considerations, this might help ease the cost burden.
Rick
Posted by Lycaste on December 30, 2000, at 18:54:36
In reply to Re: Modafinil is a controlled substance !!!, posted by Rick on December 13, 2000, at 4:53:23
I read somewhere that rats that are trained to self-administer cocaine will also self-administer Modafinil. Unfortunately, I can no longer remember where I read this, but the context in which it appeared led me to the impression that 1) the "rat" test was used to test addiction potential of a drug and that 2) if a drug "failed" the test, it was put under control. In other words, the fact that rats will self-administer Modafinil may be at least part of the reason FDA made it a controlled substance.
I could, of course, be putting 2 and 2 together and coming up with 5, but I thought I would pass it along. By the way, I am NOT suggesting that Modafinil is addicting or that it resembles cocaine in any way. I imagine there are a number of substances that rats will self-administer, given a choice.
Lycaste
> > it is a schedule 4 controlled substance, I dont think that makes it illegal though, the main problem is price, from the IAS site it would cost $1800 to $3600 a year! thats crazy!
>
>
> > it is a schedule 4 controlled substance, I dont think that makes it illegal though, the main problem is price, from the IAS site it would cost $1800 to $3600 a year! thats crazy!.
>
> ----
> For perspective on the controlled substance count, the old pain standby Tylenol w/Codeine is in a more tightly controlled class (3), and Ritalin is in a *much* more tightly controlled class (2). It's hard to understand why the FDA designated Provigil a controlled substance at all. Although I'm not positive, I believe neither France nor England place Provigil in a controlled class. I think the reasons for control in the U.S. are:
>
> -- Concern that some people will abuse it by taking it late to stay awake when they should be getting sleep.
>
> -- Lingering thought that Provigil must have some abuse potential simply because the traditional, amphetamine-based stimulants do.
>
> -- So that importer Cephalon could get quicker approval for the drug.
>
> -- Because Cephalon is relatively small and doesn't have the resources and clout to fight any unfounded FDA concerns. I always think it's interesting that a med like Provigil, which research shows rarely causes withdrawal problems is controlled, when a non-controlled AD like Paxil causes many people to experience major withdrawal difficulties. If Provigil were imported by giant Smith Kline Beecham instead of little Cephalon, I think it's very likely it would not have ended up with a controlled designation. (Fyi, I stopped Provigil cold turkey for one week with no physical effects except a little more fatigue, and some mild loss of the therapeutic benefits of my Klonopin/Serzone/Provigil combo. Again, maybe it's the fear that some people will use Provigil as a way to purposely avoid sleeping. (By the way, it does not usually cause insomnia if taken as intended. Provigil helps me stay awake and alert when I want to be, but doesn't interfere with my sleep in the least -- even the occasional daytime nap.)
>
> Regarding the expense, Cephalon is (or at least was) offering some kind of financial assistance.
> But I never read the details...maybe you have to be diagnosed with narcolepsy, which is the only official FDA-approved use thus far (even though it is used for other disorders half the time). Check out www.provigil.com. for info on the financial assistance, it it's stil being offered.
>
> Also, regarding cost, most of the time I use only 100 mg/day -- half of the typical recommended dose of 200mg. I get 200 mg tablets which are easy to snap in half with your hands. Depending on the curent prices and/or insurance considerations, this might help ease the cost burden.
>
> Rick
Posted by Rick on January 1, 2001, at 22:58:28
In reply to Re: Modafinil is a controlled substance !!!, posted by Lycaste on December 30, 2000, at 18:54:36
Good point. I recalled seeing an abstract about that study, too. I easily dug it up again by entering "modafinil and rats and self" in the Medline search box. Based on the reinforcing behavior seen in rats, the authors of that 1996 study concluded that high doses of modafinil might cause addiction.
Here is what I found on Medscape's current modafinil monograph:
Abuse and Misuse Potential:
Patients should be followed closely during modafinil use for possible signs of misuse or abuse (e.g., incrementation of doses, drug-seeking behavior), especially those with a history of drug or stimulant abuse (e.g., amphetamine, cocaine, methylphenidate). Although modafinil can produce psychoactive and euphoric effects and feelings consistent with other CNS stimulants (e.g., methylphenidate), current evidence indicates that the risk of abuse or misuse of modafinil is lower than that associated with such CNS stimulants that are subject to control as schedule II drugs (e.g., amphetamine, methylphenidate). Therefore, modafinil is only subject to control as a schedule IV drug.
Rick
> I read somewhere that rats that are trained to self-administer cocaine will also self-administer Modafinil. Unfortunately, I can no longer remember where I read this, but the context in which it appeared led me to the impression that 1) the "rat" test was used to test addiction potential of a drug and that 2) if a drug "failed" the test, it was put under control. In other words, the fact that rats will self-administer Modafinil may be at least part of the reason FDA made it a controlled substance.
>
> I could, of course, be putting 2 and 2 together and coming up with 5, but I thought I would pass it along. By the way, I am NOT suggesting that Modafinil is addicting or that it resembles cocaine in any way. I imagine there are a number of substances that rats will self-administer, given a choice.
>
> Lycaste
>
>
>
>
> > > it is a schedule 4 controlled substance, I dont think that makes it illegal though, the main problem is price, from the IAS site it would cost $1800 to $3600 a year! thats crazy!
> >
> >
> > > it is a schedule 4 controlled substance, I dont think that makes it illegal though, the main problem is price, from the IAS site it would cost $1800 to $3600 a year! thats crazy!.
> >
> > ----
> > For perspective on the controlled substance count, the old pain standby Tylenol w/Codeine is in a more tightly controlled class (3), and Ritalin is in a *much* more tightly controlled class (2). It's hard to understand why the FDA designated Provigil a controlled substance at all. Although I'm not positive, I believe neither France nor England place Provigil in a controlled class. I think the reasons for control in the U.S. are:
> >
> > -- Concern that some people will abuse it by taking it late to stay awake when they should be getting sleep.
> >
> > -- Lingering thought that Provigil must have some abuse potential simply because the traditional, amphetamine-based stimulants do.
> >
> > -- So that importer Cephalon could get quicker approval for the drug.
> >
> > -- Because Cephalon is relatively small and doesn't have the resources and clout to fight any unfounded FDA concerns. I always think it's interesting that a med like Provigil, which research shows rarely causes withdrawal problems is controlled, when a non-controlled AD like Paxil causes many people to experience major withdrawal difficulties. If Provigil were imported by giant Smith Kline Beecham instead of little Cephalon, I think it's very likely it would not have ended up with a controlled designation. (Fyi, I stopped Provigil cold turkey for one week with no physical effects except a little more fatigue, and some mild loss of the therapeutic benefits of my Klonopin/Serzone/Provigil combo. Again, maybe it's the fear that some people will use Provigil as a way to purposely avoid sleeping. (By the way, it does not usually cause insomnia if taken as intended. Provigil helps me stay awake and alert when I want to be, but doesn't interfere with my sleep in the least -- even the occasional daytime nap.)
> >
> > Regarding the expense, Cephalon is (or at least was) offering some kind of financial assistance.
> > But I never read the details...maybe you have to be diagnosed with narcolepsy, which is the only official FDA-approved use thus far (even though it is used for other disorders half the time). Check out www.provigil.com. for info on the financial assistance, it it's stil being offered.
> >
> > Also, regarding cost, most of the time I use only 100 mg/day -- half of the typical recommended dose of 200mg. I get 200 mg tablets which are easy to snap in half with your hands. Depending on the curent prices and/or insurance considerations, this might help ease the cost burden.
> >
> > Rick
Posted by Clayton on March 18, 2004, at 17:06:27
In reply to Re: Modafinil is a controlled substance !!! » Lycaste, posted by Rick on January 1, 2001, at 22:58:28
Just a brief response. If there really is such a thing a an "acctive perponality", I have it. I was addicted to meth tabs in the 1970s and more recently to Ritilin (a kinder, gentler form of speed). Both quickly build a tolerance and I incessantly bumped the dose to insane levels.
I now use Provigil. It dies NOT give me the euphoric feeling of the CNS stimulants and I do NOT increase the dose I take. I do NOT crave it it. It seems to me to be a marellousous and fairly innocuous drug.
I do not question the studies that demonstartae Provilil's abuse potential. From my personal experience, however, I would have to say that the abuse potention is at least several orders of magnitute lower than the CNS stimulants mentioned above. Personallly, I can't see how , if it doesn't seduce me, it would "hook" anyone.
Provigil has been a marvelous and efficacious adjunct to my depresrion meds (Paxil and Remaron). It also aids my short term memory and helps me to stay focused and on trank at work.
Again, I don't question the research studies, but believe this is a MUCH, MUCH safer alterative to other conventional CNS stimulants.
________________________________________________
Good point. I recalled seeing an abstract about that study, too. I easily dug it up again by entering "modafinil and rats and self" in the Medline search box. Based on the reinforcing behavior seen in rats, the authors of that 1996 study concluded that high doses of modafinil might cause addiction.Here is what I found on Medscape's current modafinil monograph:
Abuse and Misuse Potential:
Patients should be followed closely during modafinil use for possible signs of misuse or abuse (e.g., incrementation of doses, drug-seeking behavior), especially those with a history of drug or stimulant abuse (e.g., amphetamine, cocaine, methylphenidate). Although modafinil can produce psychoactive and euphoric effects and feelings consistent with other CNS stimulants (e.g., methylphenidate), current evidence indicates that the risk of abuse or misuse of modafinil is lower than that associated with such CNS stimulants that are subject to control as schedule II drugs (e.g., amphetamine, methylphenidate). Therefore, modafinil is only subject to control as a schedule IV drug.
Rick
This is the end of the thread.
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