Experts Wary as Date Rape Drug Wins New Approval

Imagine how cranky and tired you'd feel after a bad night's sleep. Now imagine that's your daily reality. For the estimated 37,000 Americans diagnosed with idiopathic hypersomnia, who never feel fully rested even after a long night's sleep, it is, per Reuters. But according to the FDA, they may now find solace in a "date rape" drug. The FDA this week approved gamma-hydroxybutyrate, or GHB, as the first treatment for idiopathic hypersomnia based on a small clinical trial of 115 patients, reports the New York Times. Patients who received the oral solution branded as Xyway reported improved sleepiness over those who received a placebo. But some experts question the results, which aren't published in a journal, and warn of side effects including depression, suicidal thoughts, and hallucinations.

What's more, experts fear people who complain to their doctors about drowsiness and grogginess may be wrongly diagnosed with idiopathic hypersomnia—Xyway's maker, Jazz Pharmaceuticals, is planning "an educational effort," per the Times—making them eligible to receive GHB. Issuances of the drug, already approved as a treatment for the chronic sleep disorder narcolepsy, are monitored through a safety program. But GHB "has serious safety concerns, both in terms of its abuse liability and its addictive potential" and "the potential for the scope of use to expand is very real, so that is concerning to me," Dr. Lewis S. Nelson, director of medical toxicology at Rutgers New Jersey Medical School, tells the Times. Nightly treatments of Xyway and an older version called Xyrem cost about $100,000 per year. (More FDA stories.)