The Magazine for Sleep Professionals
Saturday, April 18, 2026
Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult […]
Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore. Both the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) […]
Sleep and wakefulness are carefully balanced by a network of brain regions. Yet for many years, scientists couldn’t pinpoint exactly which neurons regulated sleep state transitions. New research tools and a deeper understanding of brain signaling have led to new discoveries in dopamine and norepinephrine signaling, offering novel insights into […]
Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will […]
Takeda announced that the New England Journal of Medicine published data from the Phase 2b trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to restore orexin signaling to address the underlying orexin deficiency that causes NT1. Results demonstrated […]
Sleep Pharmaceutical Update Nov/Dec 2024 Eight abstracts presenting data from across the sleep portfolio of Jazz Pharmaceuticals plc were featured at the 37th annual Psych Congress, held Oct. 29–Nov. 2, 2024 in Boston. That data included topline results of the Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, […]
Axsome Therapeutics, Inc. has announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy in the SYMPHONY Phase 3 trial. AXS-12 also reduced excessive […]
Avadel Pharmaceuticals plc announced that the U.S. Food & Drug Administration (FDA) has granted final approval to LUMRYZ, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. With final approval, LUMRYZ becomes […]
Jazz Pharmaceuticals plc announced that 13 abstracts sponsored by Jazz Pharmaceuticals and five abstracts from investigator-sponsored trials will be presented at SLEEP 2021, the 35th annual meeting of the Associated Professional Sleep Societies (APSS) from June 10-13, 2021. “Jazz continues to be committed to deepening our understanding of sleep disorders and delivering […]
Harmony Biosciences Holdings, Inc. announced the FDA has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled […]
