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# FDA Clears Cereve Sleep System
- URL: https://www.fdaweb.com/fda-clears-cereve-sleep-system/
- Published: 2016-06-06T12:00:00.000Z
- Updated: 2026-09-14T21:07:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135850

FDA has cleared a Cereve de novo petition to allow marketing of its Sleep System, a prescription device that the company says is intended to reduce latency to Stage 1 and Stage 2 sleep for people with insomnia. The device was developed based on research at the University of Pittsburgh that confirmed that the frontal cortex, or executive brain, stays active in people with insomnia during sleep, preventing them from getting deeper, more restorative sleep, according to the company.

The Sleep System comprises a software-controlled bedside device that cools and pumps fluid to a forehead pad that is worn through the night. Cereve says the device works by gently cooling the forehead within a precise, clinically-proven therapeutic range in order to reduce activity in the frontal cortex.

The submission included data from more than 230 patients over 3,800 research nights. Results from polysomnographic sleep measurements of subjects in sleep labs “showed a statistically significant reduction in latency to Stage 1 sleep, the time it takes to get into the first stage of sleep, as well as latency to Stage 2 sleep,” the company says.