European Medicines Agency decided against Xyrem (sodium oxybate)

Adrienne Dellwo, March 21, 2011
The European Medicines Agency has decided against recommending Xyrem (sodium oxybate) for treating fibromyalgia in adults. To date, the European Union doesn't have any medications approved for fibromyalgia.
Xyrem is approved in both the EU and the U.S. for narcolepsy and cataplexy (a narcolepsy symptom.) The U.S. FDA rejected this medication as a fibromyalgia treatment in October 2010, citing concerns over safety because it's similar to the date-rape drug GHB.
In clinical trials, Xyrem has been shown to improve the quality of stage-four sleep in fibromyalgia. Disrupted deep sleep is believed to be a primary contributor to symptoms of this illness and may play a role in its pathogenesis.
http://chronicfatigue.about.com/b/2011/03/21/eu-says-no-to-proposed-fibromyalgia-drug.htm

Jazz Pharmaceuticals: JZP-6 rejected by FDA

It wasn’t exactly the way that California-based Jazz Pharmaceuticals wanted to start the week.
On Monday, October 11, word came through from the Food & Drug Administration that it had rejected the company’s fibromyalgia treatment called JZP-6.
The reason? Turns out it contains sodium oxybate – an active ingredient in GHB, also known as “the date rape drug.”
http://www.investmentu.com/2010/December/when-an-fda-rejection-is-a-good-thing.html