Clinical Insights

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1
Narcolepsy Sleep Pharmaceuticals

U.S. FDA Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

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 […]

aesyra Intelligent Oral Appliance Uses Biofeedback to Reduce Bruxism by 60%
Dental Sleep Medicine Product/Vendor Updates

AesyBite Oral Appliance Uses Biofeedback to Reduce Bruxism by 60%

Aesyra SA has announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback. The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the […]

Patch-Based Onera Sleep Test Demonstrates PSG Accuracy Outside the Sleep Lab
Clinical Insights Home Sleep Testing (HST) Industry News Polysomnography Respiratory

Patch-Based Onera Sleep Test Demonstrates PSG Accuracy Outside the Sleep Lab

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 […]

quviviq Daridorexant dual orexin receptor antagonist
Sleep Pharmaceuticals Product/Vendor Updates

QUVIVIQ Wins Best Biotechnology & Pharmaceutical Product

Idorsia Ltd announces that its novel treatment for insomnia disorder QUVIVIQ (Daridorexant) has been awarded the inaugural Prix Galien Bridges Award in the category of “Best Biotechnology & Pharmaceutical Product”. The award recognizes groundbreaking medicines, including biologics, gene therapies, and traditional pharmaceutical compounds, that advance patient care through scientific innovation. […]

kricket cpap kpap sleepres
Sleep Disorders Central Sleep Apnea CPAP/Interfaces Obstructive Sleep Apnea PAP Therapy & Ventilation Systems Product/Vendor Updates

FDA Clears Kricket Positive Airway Pressure Device with KPAP

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, […]