Take Sleep Back. Move Life Forward.

Health care professionals and their patients have a 21st century option to improve sleep. NightWare is a prescription digital therapeutic system for the reduction of sleep disturbance related to Nightmare Disorder or nightmares from post-traumatic stress disorder (PTSD). It is the first and only FDA-cleared, prescription digital therapeutic that improves sleep in adults 22 and older with Nightmare Disorder or nightmares related to PTSD.


Breakthrough Device

In 2020, the FDA designated NightWare a Breakthrough Device. It's the agency's way to acknowledge new treatments are needed for a condition that is life threatening or irreversibly debilitating where there is an unmet medical need and preliminary clinical evidence demonstrating the treatment may result in substantial improvement on a clinically significant endpoint.  It also allows the FDA to expedite the development and review of these devices.
PRODUCT

A LOW-RISK TREATMENT

According to a Nov. 6, 2020 FDA news 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."

- Carlos Peña, Ph.D.
Dir., Office of Neurological and Physical Medicine Devices
FDA Center for Devices and Radiological Health

FDA RELEASE

A Commitment to Evidence-based Medicine

NightWare’s safety and efficacy is supported by data from our ongoing randomized, double-blind, placebo-controlled^ clinical trial. We are generating a larger body of evidence by completing our pivotal trial by expanding to additional study sites and conducting new studies.

CLINICAL TRIAL
^A sham device that did not provide an active intervention.


Image
Image

A Passion To Deliver Value

The NightWare prescription digital therapeutic system uses intuitive Apple® products. We designed NightWare for patients who suffer from severe nightmares that are adversely impacting their sleep. It's also important to us to provide physicians with an additional product that can help them improve sleep quality for their patients experiencing nightmares associated with PTSD and trauma.

As an FDA-cleared Class II medical device, NightWare:

Image
Helps patients with Nightmare Disorder improve their sleep within two weeks1
Image
Is designed to reduce sleep disturbances without waking the patient
Image
Tailors the therapy based on each patient’s sleep patterns, adjusting treatment interventions as the device learns more about a patient's unique sleep patterns
Image
Delivers a low-risk treatment that has no known drug interactions
Image
Improves sleep quality quickly
Image
Can be used with other treatments for nightmares and can be used with existing therapies for PTSD

“Nearly three of four people with PTSD experience nightmares, and they affect up to eight percent of the general population.” 2

OUR STORY, OUR FOCUS

Learn about our company and why we are dedicated to improved sleep.
ABOUT

BREAKTHROUGH DEVICE

Discover the Four Steps to Better Sleep and learn more about NightWare.
PRODUCT
SIGN UP FOR ALERTS
If you would like to receive news and alerts from the company, please provide your email below and we will keep you informed of important developments.

By selecting “SIGN UP FOR ALERTS,” I agree that: (1) The information I’ve provided will be used by NightWare, Inc. and its contracted third parties to email me helpful information about nightmares and PTSD and related treatments, products and services, and for marketing and information. (2) NightWare will not sell my name or contact information to any third party for its marketing use. (3) I am at least 18 years of age.