F.D.A. Approves GHB, a ‘Date Rape’ Drug, for Rare Sleeping Disorder
In the 1960s, the drug was given to women during childbirth to dampen their consciousness. In the 1990s, an illicit version made headlines as a “date rape” drug, linked to dozens of deaths and sexual assaults.
And for the last two decades, a pharmaceutical-grade slurry of gamma-hydroxybutyrate, or GHB, has been tightly regulated as a treatment for narcolepsy, a disorder known for its sudden sleep attacks.
Now, the Food and Drug Administration has approved the drug for a new use: treating “idiopathic hypersomnia,” a mysterious condition in which people sleep nine or more hours a day, yet never feel rested. Branded as Xywav, the medication is thought to work by giving some patients restorative sleep at night, allowing their brains to be more alert when they wake up. It is the first approved treatment for the illness.
But some experts say the publicly available evidence to support the new approval is weak. And they worry about the dangers of the medication, which acts so swiftly that its label advises users to take it while in bed. Xywav and an older, high-salt version called Xyrem have a host of serious side effects, including breathing problems, anxiety, depression, sleepwalking, hallucinations and suicidal thoughts.