The FDA has approved the Cerêve Sleep System (Cerêve, Oakmont, PA) device designed to reduce latency to stage 1 and stage 2 for patients suffering from insomnia.

Indication: The sleep system is designed to cool the forehead within a therapeutic range to reduce activity in the front cortex. The device consists of a software-controlled bedside device which cools and pumps fluid into a forehead pad worn throughout the night.

Clinical studies: Three independent clinical studies conducted on more than 230 patients over 3,800 research nights demonstrated the safety and efficacy of this novel device. A pivotal clinical study of the device indicated that patients treated with the device showed a statistically significant reduction in latency to reaching the first and second stage of sleep. Two additional studies indicated quality of sleep improvements over 30 days.

Safety: The device offers a clinically proven and safe alternative to sleeping pills, according to the company.

Citation: FDA clears novel drug-free technology for treating insomnia patients by helping them get to sleep faster. [news release]. Oakmont, PA: Cerêve; June 6, 2016: http://cerevesleep.com/press-release.aspx.Accessed June 13, 2016.