Medications for Idiopathic Hypersomnia | PWN4PWNSkip to contentDonateJoinIdiopathic Hypersomnia Medications: FDA-Approved & Off-Label OptionsMEDICATIONS FOR IDIOPATHIC-HYPERSOMNIA (IH)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:ModafinilArmodafinilThese are used off-label to help reduce excessive daytime sleepiness in IH patients.Psychostimulants:AmphetaminesMethylphenidateThese 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.In summary:MedicationFDA Approval for IHNotesXywavYesFirst FDA-approved drug for IH; REMS program requiredModafinilNo (off-label)Wakefulness-promoting agentArmodafinilNo (off-label)Wakefulness-promoting agentAmphetaminesNo (off-label)PsychostimulantMethylphenidateNo (off-label)PsychostimulantSodium oxybate (Xyrem)No (off-label)Used in related sleep disordersLumryzNo (off-label)Extended-release oxybate formulation Xywav remains the only medication with an official FDA indication for idiopathic hypersomnia, while other agents are used off-label to manage symptomsEmail First Name Last Name SubscribeConnect with PWN4PWN on Social Media for IH Treatment Updates© 2022 PWN4PWN. All Rights Reserved, Xywav is used for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients with narcolepsy, and idiopathic hypersomnia (IH). Includes Xywav side effects, interactions and indications., Learn about an FDA-approved treatment for cataplexy and/or excessive daytime sleepiness in narcolepsy and for idiopathic hypersomnia (IH) in adults. See full Prescribing Information & BOXED Warning about serious side effects, CNS depression, and misuse and abuse..