The Food and Drug Administration (FDA) has granted clearance for the Cereve Sleep System, a prescription device intended to reduce latency to Stage 1 and Stage 2 sleep in patients with insomnia

Eric Nofzinger, MD, the company’s founder, stated, “This is the first and only insomnia device cleared to reduce sleep latency to Stage 1, the first stage of sleep, as well as Stage 2, a stage of sleep that typically represents over 50% of the sleep period.” 

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The development of the Cereve Sleep System was motivated by patients with insomnia who described “racing minds” that prevented them from sleeping soundly. Functional brain imaging studies confirmed that the frontal cortex remained active in patients with insomnia during sleep, limiting a deeper and more restorative sleep. Dr. Nofzinger concluded that gently cooling the forehead within a clinically proven therapeutic range could reduce the activity in the frontal cortex.

Three separate clinical studies evaluating 230 patients over 3,800 research nights demonstrated the safety and efficacy of the sleep system. In a randomized, placebo-controlled trial of patients with primary insomnia, patients had a statistically significant reduction in latency to Stage 1 sleep and Stage 2 sleep as assessed by polysomnographic sleep measurements in sleep labs. Further, patients’ self-reports in two other studies showed an improvement in quality of sleep over 30 days of in-home use of the Cereve Sleep System. 

The Cereve Sleep System contains a software-controlled bedside device that cools and pumps fluid to a forehead pad worn overnight. Users reported that the device was easy to use and wear, and that it provided a calming and comfortable experience. 

The Cereve Sleep System is anticipated to launch in the second half of 2017.  

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