FDA clears software-controlled device for insomnia

The FDA recently granted commercial clearance for the Cerêve Sleep System, a bedside device that cools and pumps fluid to a forehead pad worn through the night, for insomnia.

Cerêve’s application was evaluated by the FDA under a de novo classification.

“We are thrilled that the FDA has cleared the Cerêve Sleep System for treating people with insomnia,” Eric Nofzinger, MD, founder, director and chief medical officer of Cerêve, said in a press release. “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. The Cerêve System offers a clinically-proven and safe alternative to pills, with the potential to help millions of Americans get to sleep fast.”

Eric Nofzinger

Safety and efficacy of the sleep system were evaluated in three clinical studies conducted among approximately 230 individuals over 3,800 research nights.

Findings from a randomized, placebo-controlled trial of individuals with primary insomnia across seven clinical sites indicated a statistically significant reduction in latency in stage 1 and stage 2 sleep.

Self-reports indicated sleep quality improved over 30 days of in-home use of the Cerêve Sleep System.

Craig Reynolds

Participants reported the device was easy to use and wear, according to the release.

“We are working hard to bring our new technology to market to relieve the suffering experienced by those with chronic insomnia,” Craig Reynolds, president and CEO of Cerêve, said in the release. “The importance of sleep as a vital pillar of health (along with diet and exercise) is ever increasing, and current therapeutic options available to physicians and insomnia patients are limited. The Cerêve Sleep System, which is slated to launch during the second half of 2017, will help to meet an important clinical need.”