FDA granted approval to Cerêve’s sleep system, a prescription device that reduces latency to Stage 1 and Stage 2 sleep for the treatment of insomnia.
The Cerêve System is a software-controlled bedside device that cools and pumps fluid to a forehead pad that is worn through the night, in order to reduce activity in the frontal cortex.
The system is the first of its kind to replace the most common medical treatment, sleeping pills, many of which have known safety risks. Nearly 9 million adults have taken prescription sleeping pills in the last 30 days, according to Eric Nofzinger, a board-certified sleep physician and the company’s founder.
The Pennsylvania-based company developed its device based on imaging studies that showed increased brain function during sleep in patients with insomnia.
The FDA evaluated the company’s application under a de novo classification for novel, low-risk devices based on three independent clinical studies conducted with 230 patients over 3,800 research nights.
The Sleep System is slated to launch during the second half of 2017. — Joya Patel