The Magazine for Sleep Professionals
Saturday, May 2, 2026
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 […]
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.1,2 Xywav is an oxybate product with […]
Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials of Nearly 2,000 Patients Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced the U.S. Food and Drug Administration (FDA) approved DAYVIGOTM (lemborexant) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized […]
Harmony Biosciences, LLC (Harmony) announced yesterday that FDA approved WAKIX®(pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). […]
By Victoria Knight Kaiser Health News When doctors told Frances Faulkenburg she had sleep apnea, she was more than ready for relief from her tired-all-the-time existence. She used to fall asleep at red lights while behind the wheel. At night, she’d wake up gasping for air, heart pounding. Her husband told […]
Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved Sunosi™ (solriamfetol) to improve wakefulness in adult patients […]
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The updated Prescription Drug User […]
Platform presentation highlights open-label, long-term safety and tolerability results, durability of effect over time in both EDS and cataplexy in patients with narcolepsy Harmony Biosciences, LLC (Harmony) recently presented new data on pitolisant at the 7th International Symposium on Narcolepsy in Beverly, MA. Pitolisant is an investigational product that has […]
