NightWare

by NightWare  · Based in United States → — Take Sleep Back. Move Life Forward.
Psychiatry Sleep Medicine
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Overview

NightWare is an FDA-cleared prescription digital therapeutic system designed to reduce sleep disturbance due to nightmares in adults with 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 these conditions. The system uses a proprietary, patented artificial intelligence (AI) algorithm running on a dedicated, closed-system kit that includes a preprogrammed Apple Watch and iPhone. The Apple Watch monitors the user’s heart rate and movement in real-time. The AI analyzes this biometric data to create a unique sleep profile and calculate a “stress index.” When the system detects the onset of a nightmare, it delivers gentle, vibrotactile interventions (vibrations) through the Apple Watch to interrupt the nightmare without fully waking the user. NightWare is intended for home use and should be used in conjunction with prescribed medications and other recommended therapies for PTSD, as it is not a standalone treatment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared Class II Medical Device
  • AI-powered personalized therapy (Machine Learning)
  • Vibrotactile feedback to interrupt nightmares without waking the user
  • Real-time heart rate and movement monitoring
  • Dedicated closed-system Apple Watch and iPhone kit
  • Non-pharmacological treatment option
  • Improves sleep quality in as little as two weeks
  • Low-risk treatment with no known drug interactions
  • Adapts to individual sleep patterns over time
  • Can be used with other treatments for nightmares and PTSD

Use Cases

  • Temporary reduction of sleep disturbance due to nightmares in adults with Nightmare Disorder
  • Temporary reduction of sleep disturbance due to nightmares in adults with PTSD
  • Improving sleep quality in patients experiencing frequent and disturbing nightmares
  • Providing a non-pharmacological treatment option for nightmares
  • Adjunctive therapy for PTSD management
  • Home use for ongoing nightmare management

What Physicians Need to Know

Therapeutic Modality
NightWare is a prescription digital therapeutic that uses a patented algorithm and haptic feedback via an Apple Watch to interrupt nightmares in real-time without waking the patient. It is designed to be used as part of a comprehensive treatment plan for PTSD, alongside therapy and medication, and its mechanism of action is distinct from pharmacologic and behavioral approaches like Image Rehearsal Therapy or Cognitive Behavioral Therapy (CBT).
Crisis Detection & Escalation
NightWare is not a crisis intervention tool. For individuals in crisis, it directs users to contact the Veterans Crisis Line.
PHQ-9/GAD-7 Integration
In an open-label pilot study, the Patient Health Questionnaire 9 (PHQ-9), a standard questionnaire for depressive symptoms, demonstrated a 6-point improvement with NightWare use. The Pittsburgh Sleep Quality Index (PSQI) is used as a primary outcome measure in clinical trials to assess sleep quality and disturbances.
Patient Safety Guardrails
NightWare is FDA-cleared (Class II medical device) and prescription-only. It is contraindicated for patients who have acted out their nightmares (e.g., sleepwalking, violence). Warnings include contacting a healthcare provider if daytime sleepiness, awakenings not associated with nightmares, persistent/worsening/recurring nightmares, or skin irritation occur. NightWare is not a standalone therapy for PTSD and should be used in conjunction with clinician-directed care as part of a comprehensive PTSD treatment plan.
Between-Session Support
NightWare works automatically while the patient sleeps, continuously monitoring heart rate and movement to detect and interrupt nightmares. It requires no active effort from the patient during sleep.
Outcome Measurement
NightWare's efficacy has been evaluated using the Pittsburgh Sleep Quality Index (PSQI), which assesses sleep quality and disturbances. Clinical trials have shown statistically significant improvement in patient-reported sleep quality in adherent users. An open-label pilot study also showed a 6-point improvement in the PHQ-9.
Provider Dashboard
While not explicitly called a 'provider dashboard,' NightWare's system involves patient data being collected and evaluated to create a custom sleep profile and provide interventions. Patients complete periodic surveys and attend scheduled check-ins with their care team, and their feedback helps track progress.
Cultural Sensitivity
NightWare recognizes that many veterans prefer the term 'PTS' instead of 'PTSD' and aims to support the needs of all veterans.
Physician Tip

NightWare is an FDA-cleared prescription digital therapeutic for adults 22 years or older with nightmare disorder or PTSD-related nightmares. It is crucial to remember that NightWare is an adjunctive therapy and should be integrated into a comprehensive treatment plan, not used as a standalone solution. Screen patients carefully for contraindications, particularly a history of acting out nightmares (e.g., sleepwalking, violence). Advise patients on potential side effects like daytime sleepiness or skin irritation and instruct them to contact you if these occur or if nightmares persist or worsen. Emphasize consistent use for optimal outcomes, as studies indicate stronger effects in adherent users. The device provides objective data on sleep patterns and nightmare interruptions, which can be valuable in monitoring treatment progress.

NightWare operates as a closed system, utilizing a specially provisioned Apple Watch and iPhone to run its proprietary application. It leverages the Apple Watch's heart rate sensor, accelerometer, and gyroscope to monitor sleep patterns and deliver haptic feedback. While it collects biometric data for its algorithm, there is no information suggesting direct integration with broader EHR systems for automated PHQ-9/GAD-7 scoring or session note generation. Patient feedback and progress are typically managed through periodic surveys and direct check-ins with the care team.

Details

Category Mental & Behavioral Health AI, Wearables & Remote Monitoring (RPM)
Pricing Subscription
  • Estimated out-of-pocket cost approximately $7,000; company actively seeking insurance coverage; currently covered by Highmark Health BCBS, VA, and DoD
DeploymentSaaS, Cloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

NightWare received FDA De Novo clearance on November 6, 2020 (DEN200033) as a Class II medical device for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). It was designated a Breakthrough Device by the FDA in 2020, which expedites development and review for conditions with unmet medical needs.
Integrations
EHR Not specified
Specialties Psychiatry, Sleep Medicine

What the Web Says

NightWare is an FDA-cleared digital therapeutic device designed to reduce nightmares, particularly for individuals with PTSD. It works by using an Apple Watch to monitor heart rate and movement, and then delivers gentle vibrations to interrupt a nightmare without fully waking the user. It is a prescription-only device and is intended to be part of a broader treatment plan, not a standalone therapy.

Overall: Positive

Strengths

  • FDA-cleared and backed by clinical trials, showing promising outcomes in reducing nightmare frequency and improving sleep quality.
  • Offers a non-pharmaceutical intervention for nightmares, providing an alternative or complement to medication-based treatments.
  • Particularly useful for veterans and trauma survivors who experience frequent, disruptive nightmares.
  • Adaptive algorithm learns from the user's physiological responses over time, becoming more accurate in identifying distress signals.
  • Relatively easy to implement with little disruption to patients' lives.
  • Can reduce the number of medications a user is taking.

Limitations

  • Requires a physician's prescription and is not available over-the-counter.
  • Requires a dedicated Apple Watch and iPhone, which are provided with the prescription, and the phone's functionality is limited to the NightWare app.
  • High cost (around $7000) and often not covered by insurance, making it an out-of-pocket expense for many.
  • Does not track traditional sleep metrics like REM cycles, deep sleep duration, or snoring; its sole focus is on nightmare intervention.
  • Some users report issues with customer service, particularly regarding availability at night and on weekends, and a lack of detailed documentation.
  • Does not initiate interventions within the first 30 minutes of sleep, which can be a limitation for individuals who experience nightmares soon after falling asleep.

Based on reviews from: Wise Explainer (YouTube), Sleep Review, Thomas Farley (YouTube), Business Insider, UCHealth, Apple, NightWare (Official Website), Reddit, Twin Cities Business, Psychiatric News

Last updated: 2026-09-10

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Press & Coverage

GlobeNewswire
EXIT 156 CAPITAL AND NIGHTWARE ANNOUNCE STRATEGIC
NightWare, Inc. and Exit 156 Capital announced a strategic investment by Exit 156 in NightWare's Series C financing to advance treatment of PTSD-related nightmare disorder. The investment will accelerate NightWare's VA Pathfinder Innovation Pilot, scale commercial employer-group insurance pilots, advance hardware development, and expand its patient management program.
2026-04
Business Wire
Media Alert: NightWare Launches Campaign to Disrupt Sleep - Business Wire
NightWare launched an equity crowdfunding campaign on StartEngine to expand access to its FDA-cleared digital therapeutic device for PTSD-related nightmares. The device uses an AI algorithm to identify and disrupt nightmares without waking the user.
2024-12
NightWare
NightWare Announces Leadership Transition and Strategic Investment Plan
NightWare announced a leadership transition with Matthew Tucker taking over as CEO from Grady Hannah, alongside a strategic investment plan to bolster growth and market expansion. The company remains committed to completing its Randomized Controlled Trial (RCT) and re-engaging with payers for coverage.
2024-07
UCHealth
Is NightWare effective in reducing sleep disturbances and lowering cardiovascular risk for people with PTSD? - UCHealth
UCHealth is studying NightWare, an FDA-approved prescription digital therapeutic, to determine if it can reduce sleep disturbances and improve cardiovascular health in people with PTSD. The device monitors heart rate and body movement to disrupt nightmares without waking the user.
2023-01
PubMed
A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans - PubMed
A randomized, sham-controlled clinical trial investigated the efficacy of a wearable device for trauma-related nightmares in 65 veterans, showing preliminary evidence that the active system improved self-reported sleep quality, especially in compliant users. The study was published in the Journal of Clinical Sleep Medicine.
2023-02
Apple Newsroom
Veterans find relief from nightmares with NightWare and Apple Watch
This article highlights how veterans are finding relief from PTSD-related nightmares using NightWare in conjunction with Apple Watch and iPhone. A study in the Journal of Clinical Sleep Medicine showed improved self-reported sleep quality for NightWare users.
2022-11
PR Newswire
FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults - PR Newswire
The U.S. Food and Drug Administration (FDA) permitted marketing of NightWare, a new device for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older with nightmare disorder or PTSD. The device provides gentle vibrations through an Apple Watch based on heart rate and motion during sleep.
2020-11
Psychiatric News
Digital Nightmare Therapy Receives Breakthrough Designation | Psychiatric News
The FDA granted Breakthrough Therapy status to NightWare, a smartwatch-based therapeutic for trauma-related nightmares and nightmare disorder. The app monitors heart rate and movement, using mild vibrations to rouse users if a nightmare is detected without fully waking them.
2019-07

Videos

Product demos, reviews, and walkthroughs for NightWare.

View all on YouTube

Frequently Asked Questions

NightWare uses AI to analyze real-time biometric data from a smartwatch, identifying when a patient is experiencing a nightmare. It then delivers subtle vibratory stimuli to disrupt the nightmare without waking the patient. The AI continuously learns and adapts to individual sleep patterns and nightmare triggers to optimize its effectiveness over time.
NightWare has received FDA de novo authorization as a digital therapeutic for nightmare reduction in adults with PTSD. Prescribing physicians must ensure compliance with HIPAA regulations regarding patient data privacy and security, as the device collects and transmits sensitive health information. The manufacturer is responsible for cybersecurity measures protecting the platform and data.
Clinical alternatives include prazosin (an alpha-1 adrenergic antagonist), other pharmacotherapies, and psychotherapy such as Imagery Rehearsal Therapy (IRT). NightWare offers a non-pharmacological, non-invasive option. Clinical trials have demonstrated its safety and effectiveness in reducing nightmare distress and improving sleep quality in adults with PTSD.
The cost of NightWare can vary, and reimbursement by insurance providers is evolving as digital therapeutics gain traction. Physicians should verify coverage with individual patient's insurance plans. The financial implications for healthcare systems may include reduced costs associated with managing severe PTSD symptoms and improved patient outcomes.
NightWare's primary limitation is that it is indicated for adults 22 years or older with PTSD who are undergoing clinical care for PTSD. Potential side effects are generally mild and may include sleep disturbance if the vibrations are too disruptive, though the system is designed to minimize this. It may be less effective in patients with severe sleep disorders unrelated to PTSD or those who do not tolerate the vibratory stimuli.
Integration with EHR systems can vary depending on the specific EHR platform and NightWare's interoperability features. Physicians can typically access patient usage data and progress reports through a secure provider portal, allowing them to monitor treatment adherence and effectiveness. This data can inform clinical decision-making and facilitate discussions with patients about their sleep quality and nightmare frequency.
NightWare provides resources and support for healthcare professionals, including training materials, user guides, and customer support. This ensures that physicians and their staff are equipped to properly prescribe the device, guide patients through the onboarding process, and address any technical or clinical questions that may arise during treatment.

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Suggest an Edit → | Last Verified: 2026-09-09 | First Added: 2026-09-09
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