Idiopathic Hypersomnia
Stories
-
104 of 119 adults with hypersomnia had treatment-emergent adverse events on pitolisant
Treatment-emergent adverse events were reported for 104 of 119 adults with idiopathic hypersomnia receiving pitolisant. Long-term safety data and sleepiness scores are now available for participants from a randomized withdrawal study.
-
Harmony Biosciences posts results of Phase 3 pitolisant study in idiopathic hypersomnia
Results for the open-label study were first posted on ClinicalTrials.gov on November 13, 2026. The completed study enrolled 119 participants and assessed the long-term safety and effectiveness of pitolisant after the double-blind randomized withdrawal phase of HBS-101-CL-010.