The Magazine for Sleep Professionals
Wednesday, February 25, 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 […]
Sunrise Group, a pioneer in medical device innovation and sleep care, today announced a new peer-reviewed study in Nature Communications Medicine. Sunrise developed the only home sleep test with respiratory effort measurement that has been validated against esophageal pressure, the reference standard. The study reveals that REMOV, the Sunrise-specific marker […]
Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes […]
Inogen, Inc. has announced the launch of Aurora CPAP masks, a new product in its expanding portfolio. Aurora’s introduction marks a significant milestone in Inogen’s strategy to expand its respiratory care portfolio and now bring quality, high-performing masks to patients indicated for obstructive sleep apnea (OSA). Strategic Positioning and Market […]
Onera Health has announced the publication of a multicenter validation study of its Onera Sleep Test System (STS) in the Journal of Clinical Sleep Medicine, the official journal of the American Academy of Sleep Medicine. The study demonstrated that the patch-based Onera STS home-polysomnography (hPSG) performs comparably to gold-standard in-lab […]
Harmony Biosciences, has announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth. On track to extend the pitolisant franchise, Harmony fortifies its profile as a profitable, […]
SleepRes, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP)™ for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lbs. The SleepRes PAP system is intended for home, hospital/institutional, […]
For the millions of people managing both obesity and obstructive sleep apnea (OSA), tirzepatide (Zepbound® and Mounjaro®, Eli Lilly and Co.) may offer a welcome approach to help reduce symptoms and improve overall health and quality of life. It’s been almost exactly a year since investigators of the SURMOUNT-OSA trial […]
For millions of people, the sound of teeth grinding is more than an annoyance—it’s a nightly neuromuscular storm. Sleep bruxism, characterized by involuntary clenching and grinding of the jaw during sleep, affects an estimated 8%–15% of adults worldwide.¹ Dentists have long turned to night guards as the standard solution, shielding […]
There’s no one-size-fits-all approach for managing sleep apnea. Continuous positive airway pressure (CPAP) has been the go-to treatment for almost 40 years, but doctors have realized that some patients are not able to tolerate a CPAP mask or keep up with CPAP treatment over time. If you have a moderate […]
