Ebb Insomnia Therapy: The Silver Bullet We’ve Been Waiting For?

The company name has changed. So has the wearable part of this sleep-promoting medical device.

But the product launch at selected sleep centers is still set for the final months of 2017, with full production capacity expected next year. Here’s an update on a device that will add to research-based treatment options for people with insomnia.

Ebb Insomnia Therapy helps people fall asleep more quicklyThe company name has changed. So has the wearable part of this sleep-promoting medical device.

But the product launch at selected sleep centers is still set for the final months of 2017, with full production capacity expected next year. Here’s an update on a device that will add to research-based treatment options for people with insomnia.

What It Is

The Ebb Insomnia Therapy device was developed by Ebb Therapeutics (formerly Cerêve, Inc.). Worn at night, it consists of a soft headband (rather than the plastic cap envisioned last year) attached by a tube to a temperature regulator that sits on a bedside table. Fluid is continuously pumped through the part of the headband that rests against the forehead, cooling it down. Research has shown that by cooling the forehead, the device reduces metabolic activity in the front part of the brain and hastens the onset of sleep.

Excessive Brain Activity at Night

The bane of many insomnia sufferers at night is a mind that keeps going and going and doesn’t want to stop. Such thinking and other executive activities (planning, decision-making) are functions of the frontal cortex, or the front part of the brain, involving the metabolizing of glucose.

Functional brain imaging studies—movies of processes occurring in the brain—have shown that the brains of normal sleepers are mainly quiet at night. No activity is detected in the frontal areas. In contrast, imaging studies conducted by Ebb Therapeutics founder Eric Nofzinger have revealed a great deal of metabolic activity occurring at night in the brains of insomniacs, including activity in the frontal cortex. Published images show that at night, the brains of people with insomnia are “lit up like Christmas trees.”

Cooling the Brain

Why might cooling the brain help? For starters, our core body temperature tends to rise in the daytime and fall at night. Previous research has shown that we tend to fall asleep more readily when our core body temperature is on the downward part of the cycle.

Two early studies conducted on people with insomnia showed that cooling the forehead at night

  • reduced participants’ core body temperature, and
  • reduced metabolic activity in the brain, particularly in the frontal cortex.

When Nofzinger and colleagues conducted a third, larger study (randomized and placebo controlled), they found that wearing the device significantly reduced the amount of time it took insomnia sufferers to fall asleep.

Compared With Current Insomnia Treatments

Many medications for insomnia have unwanted side effects. Ebb Insomnia Therapy is reported to have no appreciable side effects and classified as low risk by the FDA. As for its effectiveness, only time will tell how well it stacks up against insomnia drugs such as Ambien and Belsomra. New insomnia treatments like Ebb are only required to perform significantly better than sham treatment or placebo pill to gain FDA approval.

Cognitive behavioral therapy for insomnia (CBT-I), currently the gold standard in insomnia treatments, requires effort and commitment to a rigorous, weeks-long therapeutic process. Ebb Insomnia Therapy is relatively effortless. All it involves is wearing a headband at night. Some insomnia sufferers may begin to benefit right away, according to the company website. Others may take time to adjust to the device and need to use it anywhere from 2 to 4 weeks before seeing sleep improvements.

Limitations

The device will not be sold over the counter. It requires a prescription from a licensed physician or a licensed nurse practitioner. Nor has Ebb Therapeutics said how much it will cost. The company has taken out several patents, though, so the device will not be cheap. In addition, a new fluid cartridge will need to be purchased every three months. The device and cartridges are not expected to be reimbursable by health insurance companies anytime in the near future.

It’s doubtful the device will solve the sleep problems of every insomniac. The studies show that Ebb Insomnia Therapy reduces the time it takes to fall asleep and users report, after 30 days, that it improves sleep quality. Nowhere is the company claiming the device cuts down on night-time wake-ups or increases total sleep time, two items on the wish list of many insomnia sufferers.

Even so, it may be the silver bullet that at least some insomniacs have been waiting for. Particularly if you feel your sleep problem is driven by a yammering brain that just won’t stop, Ebb Insomnia Therapy is certainly worth checking out.

Merck's New Sleeping Pill to Come Out Soon

Roll over, Ambien! After much debate, the FDA has finally approved Merck’s new drug for insomnia. Expect to see Belsomra (a.k.a. suvorexant) on the market early next year.

So what can we hope for from this new sleeping pill and how does it differ from hypnotics available now?

Belsomra, a new sleeping pill approved for insomnia, will enter the market early next yearRoll over, Ambien! After much debate, the FDA has finally approved Merck’s new drug for insomnia. Expect to see Belsomra (a.k.a. suvorexant) on the market early next year.

So what can we hope for from this new sleeping pill and how does it differ from hypnotics available now?

 

A Different Path to Sleep

Older sleeping pills—from barbiturates and benzodiazepines to Ambien and Lunesta—induce sleep via the GABA system. GABA is the main neurotransmitter responsible for calming the brain and putting us to sleep. GABA-producing neurons are found throughout the brain, and when they start firing, other brain activity grinds to a halt. Most sleeping pills speed this process up, thus helping put us to sleep and keep us asleep.

Belsomra does not achieve its soporific effect through the GABA system. Instead, it works on the orexin system—on a much smaller group of neurons in the hypothalamus. These orexin-producing neurons are normally quiet during periods of sleep. But in the daytime they fire continuously, keeping us awake and alert. People who lack orexin neurons are narcoleptic, succumbing to irresistible sleep attacks during the day.

Insomnia sufferers may have the opposite problem, researchers have suggested. The orexin neurons in our brains may be overactive, keeping us awake at night. Orexin receptor antagonists such as Belsomra are being developed based on experiments that show that suppressing activity of the orexin neurons induces sleep.

How Effective Will Belsomra Be?

The FDA does not require new drugs to be more effective than older drugs before gaining approval. How Belsomra stacks up against Ambien, America’s most popular sleeping pill, is anybody’s guess.

But new drugs do have to work better than placebo. Here, Belsomra apparently passes muster. Compared with placebo, it has helped insomnia sufferers fall asleep faster and experience fewer middle-of-the-night awakenings. A year-long trial published in the May 2014 Lancet Neurology showed that after one month, insomniacs who took Belsomra got to sleep about 10 minutes faster than insomniacs taking a placebo and slept about 23 minutes longer. No great shakes! But we’re talking averages here.

Is the New Drug Safe?

A year ago there was quite a bit of concern that suvorexant in doses higher than 10 mg left a significant number of test subjects feeling groggy in the morning, impaired their driving, and led to other “narcolepsy-like” symptoms. But, based on documentation subsequently submitted by Merck, the FDA has decided to approve Belsomra for use in doses of 5, 10, 15, and 20 mg. Higher doses of the drug are said to be more effective—but they also tend to come with more side effects.

The US Drug Enforcement Agency will probably make Belsomra a scheduled drug. A Schedule IV classification would place it in the same category as Ambien and most other hypnotics on the market today. So if and when Belsomra comes on the market and you go on to try it, use it with care.

February 3, 2015: There seems to be a lot of interest in this new sleeping pill. Belsomra is now available here in the United States, and people are writing to me with questions about  effectiveness, side effects, and cost.

I have no plans to try it myself, so I can’t comment on it one way or another. But if you try Belsomra, I know others would appreciate hearing what you think about it.

You may also be interested in learning more about the safety and efficacy of Belsomra. You’ll find that information here.