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FDA Authorizes New Device to Treat PTSD-Related Nightmares

NightWare device.

Courtesy of NightWare

Key Takeaways

  • A new device, NightWare, can help stop nightmares in people who struggle with them.
  • The device works through an app and an Apple Watch and is only available by prescription.
  • There are other treatments available to help manage PTSD-induced nightmares.

The U.S. Food and Drug Administration (FDA) has approved a new tool to help combat nightmares associated with post-traumatic stress disorder (PTSD). And it comes in the form of a specialized Apple Watch and app.

The device is called NightWare, and it’s a digital therapeutic that uses an Apple Watch and an iPhone that are configured and logged into both a software application and the NightWare server. Throughout the night, the watch's sensors monitor the person’s body movement and heart rate while they sleep. The data is sent to the NightWare server and creates a unique sleep profile for the person, the FDA explained in a press release.

Through analysis of heart rate and body movement, NightWare can detect if a person is having a nightmare. And, once NightWare detects a nightmare, the device sends vibrations through the Apple Watch to try to disrupt sleep.

NightWare was studied in a 30-day randomized, controlled trial of 70 patients. At the end of the study, both people in the NightWare and control groups had improved sleep, but the NightWare group had greater benefits.

Patients who use NightWare will be given an Apple Watch with specific software that should be worn each night when the user is planning to sleep, the FDA says. It should not be used during other times, including while reading in bed or watching TV, as it may trigger false alerts.

“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need," Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. "Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares."

What This Means For You

If you struggle with recurrent nightmares, talk to your doctor about your treatment options. NightWare may be worth trying out—you'll need a prescription from your doctor first.

Vibrations as a Nightmare Treatment

PTSD is a mental health disorder that develops in some people who have witnessed a shocking, scary, or dangerous event, according to the National Institute of Mental Health (NIMH). Nearly everyone will have a range of reactions after a trauma, but most recover from those symptoms, the NIMH says. Those who continue to have problems may be diagnosed with PTSD. One of the most common signs of PTSD includes nightmares.

At its core, NightWare’s treatment is simple: It uses vibrations to interrupt sleep. “It’s an interesting idea,” W. Christopher Winter, MD, board-certified sleep medicine researcher of Charlottesville Neurology and Sleep Medicine, tells Verywell.

It’s unclear why NightWare chose to use vibrations but the subtleness of the movements could be a factor, Winter says, who is also the author of The Sleep Solution: Why Your Sleep Is Broken and How to Fix It.

NightWare isn’t the only technology to use vibrations to help with sleep. A smart ring called Thim also uses soft vibrations to gently wake you from sleep as a tool to treat insomnia. The idea, Thim claims, is that falling asleep repeatedly can condition you to sleep better.

It’s important to note that NightWare’s vibrations are unlikely to fully wake people up. “The vibration is geared to a small amount of arousal, enough to move the patient from REM sleep to deep sleep,” Gail Saltz, MD, an associate professor of psychiatry at the NY Presbyterian Hospital Weill-Cornell School of Medicine, tells Verywell. “REM is the only stage of sleep we dream in. Moving out of REM sleep ends the dreaming.” 

NightWare is not designed to be a standalone treatment for PTSD, the FDA points out—adding that it should be used along with prescribed medications for the disorder and other recommended therapies for PTSD-associated nightmares.

The device is only available by prescription, something Winter isn’t thrilled about. “I think this might be a mistake in terms of reach,” he says. Overall though, Winter says, “I see very little downside outside of potential cost.”

Current Treatments for Nightmares

Currently, nightmare disorder and nightmares associated with PTSD are treated with a combination of talk therapy and medication, Saltz, who also hosts the “Personology” podcast from iHeartRadio, says. “But the medication traditionally used—prazosin—is not really better than placebo,” she says.

In some cases, “rewriting the ending to nightmares may have some efficacy,” she says, adding that it’s not a perfect solution. “Discussing dreams is helpful in some cases, but can be re-traumatizing in others."

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  1. U.S. Food and Drug Administration. FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults. Updated November 6, 2020.

  2. National Institute of Mental Health. Post-traumatic stress disorder. Updated May 2019.