FDA Approves the First-Ever Medication for Hypersomnia
written by/ August 27, 2021
Around 40,000 Americans suffering from an excessive sleepiness disease (idiopathic hypersomnia) will soon be able to obtain their first-ever FDA medicine indicated for it—Xywav.
The drug is not a newcomer to the sleep disorder market, however. Last year, the US Food and Drug Administration (FDA) approved it for cataplexy and narcolepsy treatments.
Last Tuesday, the FDA extended the Xywav indication, and the drug is now green-lighted for idiopathic hypersomnia (IH) treatment.
IH is a debilitating life-long condition that causes excessive sleep, trouble walking, and extreme daytime sleepiness. Up until now, neither prescription sleeping pills nor the most potent over-the-counter sleep aids helped IH patients.
This is why there are great expectations for Xywav, as the only drug promising to tackle the problem at the moment.
However, the active ingredient of the promising solution is sodium oxybate—a substance known as a “date rape drug” (GHB). This powerful sedative, given its illegal use, has a high potential for abuse.
But this is not the only danger that patients fear from this medication. Xywav’s side effects range from nausea and headaches to sleep apnea, respiratory arrest, coma, and even death if mixed with other CNS depressants.
The danger of side effects with this medication is genuine, given that, by the end of June, the FDA reported over 27,000 adverse effects (among which 753 deaths) for patients who used both Xywav and Xyrem—an older generation GHB-based drug.
What is also worrying is that the FDA application (made by Jazz Pharmaceuticals, a Dublin-based company) was made following a modest clinical trial involving only 115 patients.
In any case, the FDA’s positive vote will be an enormous boost for the company. Last year, Jazz Pharmaceuticals reported $1.7 billion in profits from Xywav and Xyrem sales to patients with cataplexy and narcolepsy.