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New FDA Approved Device for Insomnia May Be More Effective Than Drugs

  [ 13 votes ]   [ 1 Comment ]
By Cort Johnson • • June 17, 2016

New FDA Approved Device for Insomnia May Be More Effective Than Drugs
Reprinted with the kind permission
of Cort Johnson and Health Rising.

Almost 80% of ME/CFS and FM patients reported that insomnia was a major or moderate problem in Health Rising’s Sleep Survey. They also often report feeling “wired and tired”. Could the two be connected? And if they are, is there anything to be done about it?

The FDA has just approved a device that claims to attack both issues. Developed by a brain imaging specialist, it aims to calm down the hyperactive areas of the brain that keep us from going to sleep quickly. Studies suggest it may be the first device that aids people in getting into the deeper stages of sleep more quickly.


Medscape reported that the FDA provided clearance for an insomnia reducing device called the Cerêve Sleep System to be sold in the U.S. Its design suggests it could have application for some people with chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM).

With almost 80% of the respondents in Health Rising's Sleep Survey reporting that insomnia was a major or moderate problem, anything that helps ME/CFS or FM patients get to sleep more quickly and deeply would obviously be a boon.

Currently, sleeping pills are the treatment of choice for most of the 55 million people in the U.S. with insomnia, but sleeping pills tend to diminish alertness, can lose potency over time, and can have other side effects.

The Cerêve Sleep System inventor, Eric Nofzinger, M.D., is a board-certified sleep physician and published researcher. In 2011, Nofzinger produced a hypothesis paper "A Neurological Model of Insomnia" that used brain imaging studies to explain insomnia differently. Nofzinger's was the first model that didn't focus on psychological-behavioral issues. Instead, it posited that persistent activation of the neural structures that produce "wake-like" states were stopping people from quickly attaining deep sleep.

In the paper, he defined insomnia in a way that may fit many people with ME/CFS/FM. Insomnia is not just difficulty falling asleep; it also incorporates "repeated awakenings with difficulty returning to sleep, or sleep that is non-restorative or poor in quality, often the perception of short overall sleep duration."

Unrefreshing sleep is a common finding in chronic fatigue syndrome and fibromyalgia. Apparently, the model also includes people who can go to sleep quickly but have trouble reaching deep sleep.

Nofzinger stated that in "deeper, more restorative sleep, the depth of our sleep was connected to how successful our brains were in quieting down, so to speak, especially in the parts of our brains that controlled our working minds."

The Cerêve Sleep System website emphasizes that the goal of the device is "calming the overactive mind" and the mental "hyperarousal" that is keeping many people from quickly entering into deep sleep.

ME/CFS/FM researcher Jarred Younger has explained that the brain heats up slightly when it becomes more active. Nofzinger's solution was simple. If the front part of the brain was "heating up," Nofzinger would cool it down using a device that pumped cooling fluids to a pad that fit on one's forehead.

Three studies, hundreds of patients and thousands of sleep lab nights later, studies indicated that Nofzinger had produced the first device that not only reduced the time it took (sleep latency) to enter into the first stages of sleep but into the second stages as well.

The Cerêve Sleep System is expected to become available during the second half of 2017. It was developed using funds from an NIH grant and with venture capital. If you're interested in the device, you can sign up to get more information as it becomes available on the the Cerêve Sleep website.

Health Rising is not affiliated with the Cerêve Sleep system in any way.
ProHealth is not affiliated with the 
Cerêve Sleep system in any way.

About the Author: ProHealth is pleased to share information from Cort Johnson.  Cort has had ME/CFS for over 30 years. The founder of Phoenix Rising and Health Rising, he has contributed hundreds of blogs on chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort's and other bloggers' work at Health Rising.

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Article Comments Post a Comment

how it works, but not for me
Posted by: Sandy10m
Sep 5, 2016
From the article: "ME/CFS/FM researcher Jarred Younger has explained that the brain heats up slightly when it becomes more active. Nofzinger's solution was simple. If the front part of the brain was "heating up," Nofzinger would cool it down using a device that pumped cooling fluids to a pad that fit on one's forehead."
If I put anything cold near my neck or forehead, I get a migraine. My migraines need heat to resolve. I can only imagine that I am in a sub-group of ME/CFS sufferers who would not be able to use this device. I thought I would point this out, since I had to search for how it works within the article.
Reply Reply
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