Medically reviewed by
Dacelin St Martin, MD
Triple board-certified in Sleep Medicine,
Internal Medicine, and Pediatrics.
PTSD-related nightmares affect almost 5 million people in the United States.
In 2019, the FDA approved the app for the Apple Watch to assist patients suffering from PTSD-related nightmares in getting a better night’s sleep. The system becomes the first therapeutic system of its kind to get FDA approval.
How will the watch aid people’s sleep, and how widely will it be available? Let’s find out.
What is NightWare?
Most PTSD patients experience frequent distressing dreams, which can severely disturb sleep patterns and are linked to an increased risk of suicide.
The US Food and Drug Administration (FDA) has officially authorized NightWare, a platform designed to help people with PTSD who suffer from recurring nightmares improve their sleep. The system, an app that runs on Apple Watches, will be available only via prescription.
“Disruptive and persistent traumatic nightmares linked with PTSD are considerably underreported and under treated, and there are no consistently effective therapy choices,” says retired US Army General and NightWare adviser Peter Chiarelli.
Chiarelli explains, “A device like the NightWare therapeutic platform, which performs the necessary mind reconnaissance to identify and interrupt post-traumatic stress-related nightmares, represents a game-changing step forward in how we can begin to properly help our veterans and active service members suffering from this debilitating condition.”
The NightWare system is an innovative program that combines an Apple Watch and a paired smartphone to understand a user’s sleep habits for ten nights.
How Does it Work?
After creating a unique sleep profile, the system monitors heart rate and body movement data to determine whether a user is having a nightmare. If a nightmare is identified, the technology sends gentle vibrations through the Apple Watch to gently break the nightmare without awakening the user.
A randomized clinical trial that collected sleep scores over 30 days showed that NightWare improved sleep scores compared to a non-vibrating sham device.
However, the FDA’s clearance is subject to several conditions. Because the gadget is being advertised as a remedy for a medically diagnosed ailment, it will only be available with a healthcare provider’s prescription.
The FDA further emphasizes that NightWare should not be used as a stand-alone therapy but as part of a larger treatment plan that includes either drugs or psychotherapy.
NightWare is not the first prescription-only app to receive approval from the FDA, which is currently designing a regulatory regime for future software-based medical devices known as “prescription digital therapies.”
If your sleep is disrupted due to PTSD-induced nightmares, talk to your doctor about a prescription for NightWare.
- FDA Food & Drug Administration. (2020, November 6). FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults. Retrieved September 28, 2022, from https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-device-designed-reduce-sleep-disturbance-related-nightmares-certain-adults
- Javidi, H., & Yadollahie, M. (2012). Post-traumatic Stress Disorder. The international journal of occupational and environmental medicine, 3(1), 2–9.
- Commissioner, O. of the. (n.d.). FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults. U.S. Food and Drug Administration. Retrieved September 28, 2022, from https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-device-designed-reduce-sleep-disturbance-related-nightmares-certain-adults
- 29, C. M. C. O., McCann, C., McCann [email protected], A. the A. R. C., McCann [email protected], C., says:, L. E., IV, R. H., Morris, J. E., Herman, B., & Mast, J. (2022, September 13). Realizing the promise of Prescription Digital Therapeutics. STAT. Retrieved September 28, 2022, from https://www.statnews.com/2019/10/29/prescription-digital-therapeutics-realizing-promise