Sleep Insomnia, a real problem for many is just getting to sleep.
A staggering 55 million Americans meet the clinical definition of insomnia, experiencing not only problems getting to sleep but also serious impairment in their daytime activities.
The cost of insomnia in the U.S. is over $100 billion annually, including poorer workplace performance, increased health care utilization, and increased accident risk. To date, sleeping pills have been by far the most common medical treatment with nearly nine million adults having taken prescription sleeping pills in the last 30 days.
Unfortunately, these pills come with well-established safety risks, in particular decreased mental alertness the morning after use, even if users feel fully awake. These medications can cause next-day impairment of driving and other activities that require full alertness, leading physicians and consumers alike to seek a drug-free alternative.
“We are thrilled that the FDA has cleared the Cerêve Sleep System for treating people with insomnia,” states Eric Nofzinger, M.D., a board-certified sleep physician and the company’s founder. “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.”
- The inspiration behind the Cerêve System came from pioneering functional brain imaging studies that Dr. Nofzinger conducted at the University of Pittsburgh. Patients with insomnia often describe “racing minds” that prevent them from sleeping soundly.
The functional brain imaging studies confirmed that the frontal cortex, or executive brain, stays active in people with insomnia during sleep, preventing them from getting deeper, more restorative sleep. Dr. Nofzinger’s solution: gently cooling the forehead within a precise, clinically-proven therapeutic range in order to reduce this activity in the frontal cortex.
Three independent clinical studies conducted on more than 230 patients over 3,800 research nights demonstrated the safety and efficacy of this novel device.
The Company’s pivotal clinical study was a randomized, placebo-controlled trial of people with primary insomnia at seven clinical sites across the U.S. Results from polysomnographic sleep measurements of subjects in sleep labs (the gold standard for evaluating sleep) 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.
Across two additional studies, self-reports from patients demonstrate that the quality of their sleep improved over 30 days of in-home use of the Cerêve Sleep System.
The FDA evaluated the company’s application under a de novo classification for novel, low risk devices. Clinical studies over 3,800 nights confirmed this low-risk safety profile.
Source.
