Launching the First FDA Approved Treatment in IH

Today, alongside our Jazz colleagues and the greater neurology community, I am excited to announce the launch of the first-ever U.S. FDA approved treatment for idiopathic hypersomnia, a unique medical condition that is often debilitating both physically and emotionally.

As a long-time priority of Jazz, we are committed to developing new medicines where others have not, to benefit people living with limited to no treatment options. For most of the disease areas within our focus, there were either no suitable treatment options or limited effective treatment options until we developed or made one available. The commercial launch of this new therapeutic product is a meaningful milestone for those living with idiopathic hypersomnia who have previously felt unheard and undertreated, as well as a proof-point to our continued commitment to patients with unmet medical needs.

Idiopathic hypersomnia, a debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness, as well as sleep inertia, or prolonged difficulty waking with frequent reentries into sleep, confusion and irritability, is a life-long condition that has been previously misunderstood and misdiagnosed.1,2,3,4 We believe all people, particularly those who live with complex conditions, deserve new and better therapeutic options, and for the approximately 37,000 adult patients who have been diagnosed with idiopathic hypersomnia and area actively seeking care, this launch is a sign of hope the population has yet to see.5

The first product Jazz ever launched was the first FDA-approved treatment for cataplexy due to narcolepsy, and I am proud to build upon this foundation as we now launch the first treatment for those living with idiopathic hypersomnia. This milestone fuels our commitment in being a long-time leader in sleep medicine and continuing to strive to develop meaningful therapeutics for those who need it most.

1Trotti LM. Idiopathic Hypersomnia. Sleep Med Clin. 2017;12(3):331-344. doi:10.1016/j.jsmc.2017.03.009.
2American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
3Billiard M, Sonka K. Idiopathic hypersomnia. Sleep Med Rev. 2016 Oct;29:23-33. doi: 10.1016/j.smrv.2015.08.007. Epub 2015 Sep 3. PMID: 26599679.
4Khan Z, Trotti LM. Central Disorders of Hypersomnolence: Focus on the Narcolepsies and Idiopathic Hypersomnia. Chest. 2015;148(1):262-273. doi:10.1378/chest.14-1304
5Jazz Pharmaceuticals, Inc, Data on file.