Medication

Medications available for idiopathic hypersomnia (IH) include both FDA-approved and off-label options:

FDA-Approved Medication:

• Xywav (calcium, magnesium, potassium, and sodium oxybates): This is the first and only FDA-approved treatment specifically for idiopathic hypersomnia in adults. It is a lower-sodium oxybate formulation taken at night to treat symptoms such as excessive daytime sleepiness, sleep inertia, long sleep time, and cognitive impairment. Xywav was approved based on a Phase 3 clinical trial demonstrating its efficacy and safety. Due to risks of central nervous system depression and abuse potential (it contains oxybate, related to GHB), Xywav is available only through a restricted program with certified prescribers and pharmacies (REMS program) and is not sold in retail pharmacies.

Off-Label Treatments:

• Wakefulness-promoting agents:

  • Modafinil

  • Armodafinil
    These are used off-label to help reduce excessive daytime sleepiness in IH patients.

• Psychostimulants:

  • Amphetamines

  • Methylphenidate
    These stimulants are also used off-label to promote wakefulness and manage sleepiness symptoms in IH.

Other related oxybate formulations such as sodium oxybate (Xyrem) and Lumryz (an extended-release sodium oxybate) are also used but are not specifically FDA-approved for IH; their use may be off-label or for related sleep disorders.