- Federal regulators have approved the drug Xywav to treat idiopathic hypersomnia, a rare disorder that can result in daytime sleepiness.
- Xywav has already been approved for use in treating other sleep disorders, but it carries a black box warning due to potential side effects.
- Experts say sleep disruptions can be caused by mental health and nutritional factors.
People who live with excessive daytime sleepiness may have a new option for treatment, but it’s not without its risks.
Xywav, which is used to help treat the rare sleep disorder known as idiopathic hypersomnia (IH), has been
Although rare, IH is a chronic sleep disorder characterized by never feeling like you’ve had enough sleep or by the feeling of an insatiable need for sleep.
People with IH can sleep regular amounts or even longer than recommended but still not feel rested.
Xywav has been previously approved for other sleep disorders. It’s an oral medication made from:
- calcium
- magnesium
- potassium
- sodium oxybate, also known as gamma-hydroxybutyrate, or GHB
FDA officials reported that these chemical compounds were shown in a clinical trial involving 154 people from 19 to 75 years old to help reduce excessive daytime sleepiness.
The recorded side effects included:
- nausea in 21 percent of study participants
- headache in 16 percent
- dizziness in 11 percent
- anxiety in 10 percent
- vomiting in 10 percent
Xywav can only be obtained through a prescribing doctor. The FDA has issued the following black box warnings for the drug:
- central nervous system depression
- abuse
- misuse
Xywav is subject to strict safety controls on prescribing and dispensing under the FDA’s
Source: healthline