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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by utopizen on April 25, 2003, at 11:28:37
Can J Psychiatry 1981 Apr;26(3):162-6 Related Articles, Links
[Sodium gamma-hydroxybutyrate in the treatment of essential hypersomnia]
[Article in French]
Montplaisir J, Barbezieux M.
Five non-narcoleptic hypersomniac patients were given GHB (3.10 to 4.5 g per os) at night. Four patients reported a persistent improvement of their daytime sleepiness as a result of this treatment. Nocturnal polygraphic recordings were performed in all patients before and after GHB. The durations of sleep and of waking times were reduced after GHB while there was an increase of stages 3 and 4 during the first third of the night. It is possible that the increase in delta wave sleep early in the night is responsible for a re-establishment of a normal distribution of subsequent sleep stages and thus produces a more recuperative sleep.
PMID: 7237354 [PubMed - indexed for MEDLINE]
Posted by Larry Hoover on April 25, 2003, at 11:42:25
In reply to Xyrem proven for excessive daytime sleepiness, posted by utopizen on April 25, 2003, at 11:28:37
> Can J Psychiatry 1981 Apr;26(3):162-6 Related Articles, Links
>
> [Sodium gamma-hydroxybutyrate in the treatment of essential hypersomnia]
> [Article in French]
> Montplaisir J, Barbezieux M.
> Five non-narcoleptic hypersomniac patients were given GHB (3.10 to 4.5 g per os) at night. Four patients reported a persistent improvement of their daytime sleepiness as a result of this treatment. Nocturnal polygraphic recordings were performed in all patients before and after GHB. The durations of sleep and of waking times were reduced after GHB while there was an increase of stages 3 and 4 during the first third of the night. It is possible that the increase in delta wave sleep early in the night is responsible for a re-establishment of a normal distribution of subsequent sleep stages and thus produces a more recuperative sleep.
> PMID: 7237354 [PubMed - indexed for MEDLINE]Just to clear up any thoughts that you could obtain Xyrem by prescription, for off-label use....
From:
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01157.html"The Food and Drug Administration today approved Xyrem (sodium oxybate or gamma hydroxybutyrate, also known as GHB) for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles. Because of safety concerns associated with the use of the drug, the distribution of Xyrem will be tightly restricted....
Xyrem has been designated as a Schedule III Controlled Substance for medical use, meaning it cannot be sold, distributed, or provided to anyone other than for its prescribed use. Illicit use of Xyrem will be subject to penalties under Schedule I, the most restrictive schedule of the Controlled Substances Act."
Lar
Posted by Ame Sans Vie on April 25, 2003, at 12:10:09
In reply to Re: Xyrem use severely restricted » utopizen, posted by Larry Hoover on April 25, 2003, at 11:42:25
All it takes for your doctor to prescribe this drug is for him/her to attend a seminar on the use of the drug, and you have to attend as well. I went through this, and it was no big deal. Then again, I had a pdoc who was excited about GHB being used off-label. Not sure all docs would be so receptive.
Posted by utopizen on April 25, 2003, at 14:51:00
In reply to Re: Xyrem use restricted, not severely, posted by Ame Sans Vie on April 25, 2003, at 12:10:09
> All it takes for your doctor to prescribe this drug is for him/her to attend a seminar on the use of the drug, and you have to attend as well. I went through this, and it was no big deal. Then again, I had a pdoc who was excited about GHB being used off-label. Not sure all docs would be so receptive.
>The neurologist I spoke to wanted me on Xyrem because she's more comfortable about it (a schedule III) than the Desoxyn (a schedule II) I'm taking for ADD/sleepiness.
When the FDA "approves" a drug for an indication, what they mean to say is "approve the marketing" of a drug for an indication. This has generated a lot of confusion over the years, but it's because the FDA is simply to lazy to add "the marketing" phrase whenever they approve a drug for marketing on a specific indication.
The statement you read is no different than any other FDA approval statement (minus the simutaneous scheduling point). If you have it prescribed for an indication, that is a therapeutic use, and that is therefore not illicit.
Doctors don't get into trouble when they prescribe a drug off-label, and neither do patients. Only drug makers can, and that's the whole reason why they bother paying $70,000 everytime they fill out an indication application.
Every indication requires $70,000 application fee, plus a barrage of safety and efficacy tests to support it, plus the risk the application might be denied.
And a schedule III is a heck of a lot less controlled than a Schedule II, which I'm use to dealing with with my Desoxyn. It's got a central pharmacy, and requires a patient-doctor registry, but that's the only special controls it has beyond any other schedule III. And unless you think someone on this board gives out their prescriptions to others, the Schedule I issue isn't even relevant.
Posted by Larry Hoover on April 25, 2003, at 16:59:50
In reply to Re: Xyrem use restricted, not severely, posted by utopizen on April 25, 2003, at 14:51:00
> > All it takes for your doctor to prescribe this drug is for him/her to attend a seminar on the use of the drug, and you have to attend as well. I went through this, and it was no big deal. Then again, I had a pdoc who was excited about GHB being used off-label. Not sure all docs would be so receptive.
> >> When the FDA "approves" a drug for an indication, what they mean to say is "approve the marketing" of a drug for an indication. This has generated a lot of confusion over the years, but it's because the FDA is simply to lazy to add "the marketing" phrase whenever they approve a drug for marketing on a specific indication.
>
> The statement you read is no different than any other FDA approval statement (minus the simutaneous scheduling point). If you have it prescribed for an indication, that is a therapeutic use, and that is therefore not illicit.I'm sorry for misunderstanding the legislative framework. If I was in the U.S., I'm sure I'd understand it better.
Just for clarity, I now see that the FDA statement referred to its *prescribed* use, not its *approved* use. I totally misread that point, as I thought that was intended to specifically proscribe off-label use.
Interesting that the drug went from Schedule I to Schedule III.
Lar
Posted by utopizen on April 25, 2003, at 17:38:48
In reply to Re: Xyrem use restricted, not severely » utopizen, posted by Larry Hoover on April 25, 2003, at 16:59:50
> Just for clarity, I now see that the FDA statement referred to its *prescribed* use, not its *approved* use. I totally misread that point, as I thought that was intended to specifically proscribe off-label use.
>
> Interesting that the drug went from Schedule I to Schedule III.
>
> Lar
Historical context helps. In 1906, the Safe Foods and Drugs Act mandated the FDA. It was in response to elixirs claiming to cure everything around, often including opium, heroin and cocaine. Note the primary purpose of the FDA is to regulate how companies bring a drug to market, not how the drug functions once in the market. That's the job of the DEA.Note the first thing the FDA did was to require evidence of efficacy and safety in drugs on the market, not simply removing them because they happened to contain drugs like cocaine. That happened a few years later through separate congressional acts. For a bit, you could still make a cocaine product, as long as you didn't claim it cured herpes without proof.
Or another concern was falsely saying how much was in the stuff... for some reason, I guess more was being added than advertised (but wouldn't that drive up the cost without benefit??)
The FDA is unique in being able to have sole discretion over whether a drug is a Schedule I (no medicinal value) or a higher schedule. The DEA can only shift drugs from Schedules II-V, but it doesn't have the authority (nor should it) to claim a drug has no medicinal value by placing it in the Schedule I category. The FDA puts drugs in Schedule I, so it can clearly take it out. Yes, congressional acts can make this more complicated, as in the case of GHB. But then again, congressional acts can override just about anything.
Posted by Snoozy on April 25, 2003, at 22:55:46
In reply to Re: Xyrem use restricted, not severely, posted by utopizen on April 25, 2003, at 17:38:48
Thanks for all the info. here. So an MD can prescribe anything for off-label use once it's been FDA "approved"? Do you know if Schedule I is just illegal "street" drugs?
I'm not clear on how the Xyrem is supposed to work - does it make your nighttime sleep more "efficient" or "effective", allowing you to be more alert during the day?
I've read some interesting stuff about the history of drugs in the US. I think some of the patent medicines did contain more than advertised - the case with morphine, and there were addiction problems. It's interesting how the "problem" drugs changed to whatever was associated at the time with society's "undesirables".
>
> > Just for clarity, I now see that the FDA statement referred to its *prescribed* use, not its *approved* use. I totally misread that point, as I thought that was intended to specifically proscribe off-label use.
> >
> > Interesting that the drug went from Schedule I to Schedule III.
> >
> > Lar
>
>
> Historical context helps. In 1906, the Safe Foods and Drugs Act mandated the FDA. It was in response to elixirs claiming to cure everything around, often including opium, heroin and cocaine. Note the primary purpose of the FDA is to regulate how companies bring a drug to market, not how the drug functions once in the market. That's the job of the DEA.
>
> Note the first thing the FDA did was to require evidence of efficacy and safety in drugs on the market, not simply removing them because they happened to contain drugs like cocaine. That happened a few years later through separate congressional acts. For a bit, you could still make a cocaine product, as long as you didn't claim it cured herpes without proof.
>
> Or another concern was falsely saying how much was in the stuff... for some reason, I guess more was being added than advertised (but wouldn't that drive up the cost without benefit??)
>
> The FDA is unique in being able to have sole discretion over whether a drug is a Schedule I (no medicinal value) or a higher schedule. The DEA can only shift drugs from Schedules II-V, but it doesn't have the authority (nor should it) to claim a drug has no medicinal value by placing it in the Schedule I category. The FDA puts drugs in Schedule I, so it can clearly take it out. Yes, congressional acts can make this more complicated, as in the case of GHB. But then again, congressional acts can override just about anything.
>
Posted by Caleb462 on April 26, 2003, at 0:58:37
In reply to Re: Xyrem use restricted, not severely » utopizen, posted by Snoozy on April 25, 2003, at 22:55:46
> Thanks for all the info. here. So an MD can prescribe anything for off-label use once it's been FDA "approved"? Do you know if Schedule I is just illegal "street" drugs?
>Here's a helpful link.
http://www.erowid.org/psychoactives/law/law_fed_sched.shtml
> I'm not clear on how the Xyrem is supposed to work - does it make your nighttime sleep more "efficient" or "effective", allowing you to be more alert during the day?From what I understand, GHB (Xyrem) inhibits the release of dopamine for a period of time. This causes dopamine to build up in the neuron, and then upon waking, large amounts of dopamine are released - inducing increased wakefulness, motivation, etc.
There may be other mechanisms at work too, I dunno.
Posted by utopizen on April 26, 2003, at 11:41:03
In reply to Re: Xyrem use restricted, not severely, posted by Caleb462 on April 26, 2003, at 0:58:37
> From what I understand, GHB (Xyrem) inhibits the release of dopamine for a period of time. This causes dopamine to build up in the neuron, and then upon waking, large amounts of dopamine are released - inducing increased wakefulness, motivation, etc.
> There may be other mechanisms at work too, I dunno.Actually, the dopamine effects are perhaps the least understood aspect to it. The more obvious, and researched, effect of GHB is its effect on growth hormone levels and sleep architecture. If you've got odd sleep architecture, you're going to require more than 8 hours, and be tired anyway. It's called Excessive Daytime Sleepiness, and Xyrem is testing in Phase II for this indication.
People who reported being tired after 9 1/2 hours each night claim GHB let them feel alert on just 5 or 6 hours each day. It definitely makes sleep more efficient by deepening restorative sleep.
Posted by Snoozy on April 27, 2003, at 13:03:45
In reply to Re: Xyrem use restricted, not severely, posted by Caleb462 on April 26, 2003, at 0:58:37
This is the end of the thread.
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