Apnimed raised $25 million in a Series B financing led by existing investor, Morningside Ventures, and joined by new investors, Seligman Investments and Tao Capital Partners. The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the […]
Tag: SLEEP PHARMACEUTICALS
Jazz Gets FDA Approval of Xywav for Narcolepsy Related Cataplexy or EDS
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 […]
BELSOMRA Label Update Includes Insomnia Study Findings in Patients with Alzheimer’s Disease
Merck has announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an update to the prescribing information for BELSOMRA® (suvorexant) C-IV to include findings on its use for the treatment of insomnia in patients with mild-to-moderate Alzheimer’s disease. BELSOMRA is indicated for the treatment […]
FDA Approves DAYVIGO for Treatment of Insomnia in Adults
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 […]
Jazz Pharmaceuticals Announces FDA Approval of Sunosi for EDS and OSA
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 Receives New PDUFA Goal Date for Solriamfetol for EDS Associated with Narcolepsy or OSA
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 […]
Promising Data for First New Narcolepsy Drug in Ten Years, Pending Approval
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 […]









