Approved: New Device for Nightmares

FDA approves Nightware for sleep problems linked to nightmares

(RxWiki News) The US Food and Drug Administration (FDA) has approved a device for sleep problems related to nightmares.

This device is called Nightware. The FDA approved it to temporarily reduce sleep disturbances tied to nightmares.

Nightware is approved for adults who are at least 22 years old and have been diagnosed with nightmare disorder or have nightmares related to post-traumatic stress disorder (PTSD).

When someone experiences a shocking, scary or dangerous event, they can develop PTSD. And those with PTSD may experience sleep problems and nightmares.

How does Nightware work? This device uses an Apple Watch and an Apple iPhone that connect to the Nightware platform. The Apple Watch monitors your body movement and heart rate during sleep.

Using heart rate and movement data, the device can detect when you may be having a nightmare. That's when it provides vibrations through the Apple Watch. These vibrations are meant to arouse you enough to end the nightmare.

"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,” said Dr. Carlos Peña, director of the FDA's Office of Neurological and Physical Medicine Devices, in a press release.

This device is only available by prescription.

The FDA noted that Nightware is not to be used on its own as a treatment for PTSD. Instead, this device is to be used in combination with medications for PTSD, as well as with other recommended therapies for sleep problems linked to PTSD.

Nightware is not recommended for those who have been known to “act out” during nightmares through behaviors like sleepwalking.

The watch that comes in the Nightware kit is to be worn every night before going to sleep. The watch is not to be worn during activities like reading or watching TV, as you may experience false alerts.

The FDA recommended contacting a health care provider in the following situations:

  • You experience daytime sleepiness
  • If the watch vibrations fully wake you instead of only arousing you enough to end a nightmare
  • If your nightmares continue or they seem to be getting worse
  • If you experience skin irritation where the watch is worn

Do not drive or operate heavy machinery if you feel drowsy.

This approval was granted to Nightware, Inc.