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Idiopathic hypersomnia is described in the packet as a sleep disorder classified in two forms: idiopathic hypersomnia with long sleep time and idiopathic hypersomnia without long sleep time. Synonyms listed are primary hypersomnia and idiopathic hypersomnolence. The packet carries Orphanet (Orphanet:33208), GARD (GARD:8737), and MeSH (MESH:D020177) identifiers and lists the nervous system as the affected organ system. The prevalence field is recorded as unknown in this packet. One patient organization, PWN4PWN Corp, is listed with a patient registry.
The packet annotates 11 phenotypes in total and lists ten with frequency data. Sleep disturbance and excessive daytime somnolence are each annotated as very frequent (80-99%). Short attention span, memory impairment, brain fog, and sleep drunkenness are annotated as frequent (30-79%). Depression, hypnagogic hallucination, hypnopompic hallucination, and sleep paralysis are annotated as occasional (5-29%). Age-of-onset categories are not certified in this packet, and no GeneReviews clinical description is present.
The packet lists no known genes and no inheritance patterns for idiopathic hypersomnia. The underlying cause is therefore not certified in this packet and is not described here.
No diagnostic methods, GeneReviews diagnosis content, or newborn screening information are certified in this packet. The packet distinguishes two forms by name, with and without long sleep time, but does not supply criteria or tests for separating them. How the condition is diagnosed is therefore not described here.
The packet certifies one FDA-approved product with an active market status: XYWAV (calcium, magnesium, potassium, and sodium oxybates), approved under an NDA through CDER on 2020-07-21. Orphan-drug records also list Xywav as approved for the treatment of idiopathic hypersomnia. Separate orphan-drug records show orphan designation, which is not FDA approval, for idiopathic hypersomnia for mazindol (NLS Pharmaceutics), pentetrazol (Balance Therapeutics), pitolisant (Harmony Biosciences), serdexmethylphenidate (KemPharm), and sodium oxybate (Avadel CNS Pharmaceuticals). Other entries in the orphan-drug list concern different conditions, such as narcolepsy, membranous nephropathy, and Parkinson disease, and are not treatments for idiopathic hypersomnia in this packet. No foundational therapies or GeneReviews management content are certified, so other management approaches are unknown in this packet. Patient assistance programs may exist for some therapies; none are certified in this packet.
24 trials found
Natural history and prognosis are not certified in this packet, and no GeneReviews clinical description is present. No statement about disease course or outcomes is made here.
The packet reports 21 ClinicalTrials.gov records for idiopathic hypersomnia, all counted as active. Examples from the certified trial records include NCT07625280, a Phase 3 study of Xywav versus placebo in narcolepsy or idiopathic hypersomnia sponsored by Jazz Pharmaceuticals (recruiting; 2026-07-09 to 2028-01-06); NCT07500090, a Phase 3 study of HBS-301 in idiopathic hypersomnia sponsored by Harmony Biosciences (recruiting; 2026-03-16 to 2028-10-01); NCT06843590, a Phase 2 study of ALKS 2680 in idiopathic hypersomnia sponsored by Alkermes (active, not recruiting; 2025-05-22 to 2026-11-01); NCT06812078, a Phase 2 study of TAK-360 in adults with idiopathic hypersomnia sponsored by Takeda (recruiting; 2025-02-07 to 2026-11-30); and NCT06252571, a Phase 2 randomized trial combining evening melatonin and morning light therapy sponsored by University Hospital, Strasbourg (recruiting; 2024-09-07 to 2027-09-07). The packet's trial summary lists drug therapy, device, procedural, and other interventions, with no gene therapy trials. Its publication digest classifies 97 papers, with epidemiology and natural history the dominant type, 27 reviews, and 6 case reports. Trial statuses are as recorded in the packet and may have changed.
Data assembled from 6 of 12 sources · Last updated Nov 3, 2026, 11:41 PM UTC
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