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Re: Xyrem use severely restricted » utopizen

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


 

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