Which Mental Health Apps Are FDA-Approved?

Table of ContentsView AllTable of ContentsHow Does the FDA Approve Apps?What Does It Mean If an App Is FDA-Approved?Which Apps Are FDA-Approved?

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Table of Contents

How Does the FDA Approve Apps?

What Does It Mean If an App Is FDA-Approved?

Which Apps Are FDA-Approved?

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In recent years, thousands of apps have been released to help people manage their mental health.These appsare designed for various issues, includingstress,anxiety,sleep, anddaily functioning. In addition, there is a whole category of apps specifically to help autistic people communicate and address sensory issues.

Although anincrease in telehealthhas significantly improved access to care for many Americans,a shortage of qualified professionals makes it difficult for people to get the services they need.

While no app is a substitute for therapy services, apps can supplement therapy and offer additional support.

According tothe FDA’s website, “The FDA encourages the development of mobile medical apps (MMAs) that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices—including mobile medical apps.”

Essentially, technology has allowed access to resources for health and wellness that were never possible before. At the same time, though, anyone can create an app. The FDA’s role is to ensure that these apps do what they claim to do, provide support based on evidence, and benefit the people using them.

The FDA regulates apps that function as medical devices, so if an app merely provides education about mental health, it is not eligible for FDA approval. However, if an app provides a therapeutic intervention (for example), the creators might seek FDA approval to certify their app.

It can take years for an app to be approved, and the FDA might approve a specific function of the app rather than the app in its entirety.

If an app is FDA-approved, this means that the developers went through the process of requesting this approval and demonstrated that their app meets the criteria for software as a medical device.

For the software to be considered a medical device, it must be “intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

The FDA thoroughly vets apps before approving them, and it has high standards to provide this approval. Typically, an app that receives FDA approval will require a prescription and be used in conjunction with therapy or other treatment services.

As of November 2024, the FDA has approved six mental health apps, listed below.

Rejoyn

Rejoyn is the first FDA-approved app to treat depression, including major depressive disorder (MDD). It was designed specifically for people age 22 and older who need depression support and treatment beyond just their antidepressant. This app is meant to be used in conjunction with medication and outpatient treatment.

Approved in April of 2024, a prescription is required in order to sign up and use Rejoyn. Along with short, 3- to 4-minute cognitive behavioral therapy (CBT) exercises and lessons, Rejoyn is unique in focusing on improving working memory in those with MDD, the deficits of which are thought to be connected to significant MDD symptoms.

Rejoyn was FDA-approved after a clinical trial including over 350 adults who had not experienced a remission of depression symptoms on their antidepressant alone. After six weeks of using this app, users scored much lower on standard depression scale ratings, indicating that Rejoyn is a helpful resource in the compound treatment of depression.

EndeavorRx

EndeavorRxis a video game designed to treat ADHD in children ages 8-17 andreceived FDA approval in 2020. To subscribe to the app, you must have a prescription from a healthcare provider that verifies your diagnosis and the need for treatment. The app uses a science fiction backdrop to practice focus and attention using an evidence-based protocol.

The app is designed to be played for 25 minutes a day, five days a week, for at least four consecutive weeks in order to improve attention; a 30-day prescription costs $99. The game provides fun but challenging activities that teach the player to sustain attention, prioritize and selectively focus, and attend to multiple stimuli at a time.

EndeavorRx is the first-ever video game to receive FDA approval to treat attention-deficit/hyperactivity disorder (ADHD). Before receiving approval, the creators of EndeavorRx completed four peer-reviewed studies to show that the game effectively improves ADHD symptoms.

NightWare

It is not available on any app store and requires a prescription from a healthcare provider.

Clients wear the device (an Apple Watch), which senses nightmares or disturbing dreams and uses vibration to wake the client and end the dream. Research showed improvement in anxiety symptoms, reduced nightmares, and overall improved sleep quality when wearing the NightWare device.

NightWare was approved as a treatment for nightmares in 2020 in adults age 22 and older.

ReSET

This app is not approved for treating alcohol abuse in the absence of additional substance abuse, and it is not approved for opioid treatment.

ReSET-O

As with the original reSET app, reSET-O requires a prescription and is intended for collaborative use between clients and treatment providers. Unlike the reSET app, reSET-O did not have peer-reviewed research showing that it decreased opioid use in users at the time of approval. However, reSET-O users had a higher rate of retention in outpatient programs compared to those who did not use reSET-O to supplement their treatment.

The FDA granted approval for reSET-O throughpremarket registration.

Somryst

Somryst uses six lessons based in CBT-I that individuals can complete at their own pace over the course of nine weeks. It provides specific instructions based on evidence-based treatment for insomnia to help clients sleep better.

What Does This Mean for the Mental Health Field?These apps can provide support and symptom management for clients in between sessions, hoping to reinforce work done in therapy. Some, like Nightware, provide a therapeutic intervention that a traditional therapist cannot do.By regulating mental health apps, the FDA is implementing standards for these kinds of resources. This ensures that users know the risks and benefits of the apps and can rely on an evidence base for these claims. In addition, providers can make confident recommendations knowing that the FDA vetted these resources first.

What Does This Mean for the Mental Health Field?

These apps can provide support and symptom management for clients in between sessions, hoping to reinforce work done in therapy. Some, like Nightware, provide a therapeutic intervention that a traditional therapist cannot do.By regulating mental health apps, the FDA is implementing standards for these kinds of resources. This ensures that users know the risks and benefits of the apps and can rely on an evidence base for these claims. In addition, providers can make confident recommendations knowing that the FDA vetted these resources first.

These apps can provide support and symptom management for clients in between sessions, hoping to reinforce work done in therapy. Some, like Nightware, provide a therapeutic intervention that a traditional therapist cannot do.

By regulating mental health apps, the FDA is implementing standards for these kinds of resources. This ensures that users know the risks and benefits of the apps and can rely on an evidence base for these claims. In addition, providers can make confident recommendations knowing that the FDA vetted these resources first.

If you feel that an app discussed in this article would benefit your treatment, talk to your healthcare provider(s) about your options.

12 SourcesVerywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Hoffman DA.Increasing access to care: telehealth during COVID-19.J Law Biosci. 2020;7(1):lsaa043. doi:10.1093/jlb/lsaa043Food and Drug Administration.Policy for device software functions and mobile medical applications: guidance for industry and Food and Drug Administration staff.International Medical Device Regulators Forum.Software as a Medical Device (SaMD): key definitions.Pivotal clinical trial results.Clinical data: Rejoyn helped reduce symptoms of MDD.(n.d.). https://www.rejoynhcp.com/clinical-dataCanady VA.FDA approves first video game Rx treatment for children with ADHD.Ment Health Wkly. 2020;30(26):1-7. doi:10.1002/mhw.32423Anderson M.Prescription-strength gaming: ADHD treatment now comes in the form of a first-person racing game - [news].IEEE Spectr. 2020;57(8):9-10. doi:10.1109/MSPEC.2020.9150542NightWare.A modern option for your patients.Food and Drug Administration.FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults.Food and Drug Administration.FDA permits marketing of mobile medical application for substance use disorder.Pear Therapeutics.Clinical evidence.Food and Drug Administration.FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs.Morin CM.Profile of Somryst prescription digital therapeutic for chronic insomnia: overview of safety and efficacy.Expert Rev Med Devices. 2020;17(12):1239-1248. doi:10.1080/17434440.2020.1852929

12 Sources

Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Hoffman DA.Increasing access to care: telehealth during COVID-19.J Law Biosci. 2020;7(1):lsaa043. doi:10.1093/jlb/lsaa043Food and Drug Administration.Policy for device software functions and mobile medical applications: guidance for industry and Food and Drug Administration staff.International Medical Device Regulators Forum.Software as a Medical Device (SaMD): key definitions.Pivotal clinical trial results.Clinical data: Rejoyn helped reduce symptoms of MDD.(n.d.). https://www.rejoynhcp.com/clinical-dataCanady VA.FDA approves first video game Rx treatment for children with ADHD.Ment Health Wkly. 2020;30(26):1-7. doi:10.1002/mhw.32423Anderson M.Prescription-strength gaming: ADHD treatment now comes in the form of a first-person racing game - [news].IEEE Spectr. 2020;57(8):9-10. doi:10.1109/MSPEC.2020.9150542NightWare.A modern option for your patients.Food and Drug Administration.FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults.Food and Drug Administration.FDA permits marketing of mobile medical application for substance use disorder.Pear Therapeutics.Clinical evidence.Food and Drug Administration.FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs.Morin CM.Profile of Somryst prescription digital therapeutic for chronic insomnia: overview of safety and efficacy.Expert Rev Med Devices. 2020;17(12):1239-1248. doi:10.1080/17434440.2020.1852929

Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Hoffman DA.Increasing access to care: telehealth during COVID-19.J Law Biosci. 2020;7(1):lsaa043. doi:10.1093/jlb/lsaa043Food and Drug Administration.Policy for device software functions and mobile medical applications: guidance for industry and Food and Drug Administration staff.International Medical Device Regulators Forum.Software as a Medical Device (SaMD): key definitions.Pivotal clinical trial results.Clinical data: Rejoyn helped reduce symptoms of MDD.(n.d.). https://www.rejoynhcp.com/clinical-dataCanady VA.FDA approves first video game Rx treatment for children with ADHD.Ment Health Wkly. 2020;30(26):1-7. doi:10.1002/mhw.32423Anderson M.Prescription-strength gaming: ADHD treatment now comes in the form of a first-person racing game - [news].IEEE Spectr. 2020;57(8):9-10. doi:10.1109/MSPEC.2020.9150542NightWare.A modern option for your patients.Food and Drug Administration.FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults.Food and Drug Administration.FDA permits marketing of mobile medical application for substance use disorder.Pear Therapeutics.Clinical evidence.Food and Drug Administration.FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs.Morin CM.Profile of Somryst prescription digital therapeutic for chronic insomnia: overview of safety and efficacy.Expert Rev Med Devices. 2020;17(12):1239-1248. doi:10.1080/17434440.2020.1852929

Hoffman DA.Increasing access to care: telehealth during COVID-19.J Law Biosci. 2020;7(1):lsaa043. doi:10.1093/jlb/lsaa043

Food and Drug Administration.Policy for device software functions and mobile medical applications: guidance for industry and Food and Drug Administration staff.

International Medical Device Regulators Forum.Software as a Medical Device (SaMD): key definitions.

Pivotal clinical trial results.Clinical data: Rejoyn helped reduce symptoms of MDD.(n.d.). https://www.rejoynhcp.com/clinical-data

Canady VA.FDA approves first video game Rx treatment for children with ADHD.Ment Health Wkly. 2020;30(26):1-7. doi:10.1002/mhw.32423

Anderson M.Prescription-strength gaming: ADHD treatment now comes in the form of a first-person racing game - [news].IEEE Spectr. 2020;57(8):9-10. doi:10.1109/MSPEC.2020.9150542

NightWare.A modern option for your patients.

Food and Drug Administration.FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults.

Food and Drug Administration.FDA permits marketing of mobile medical application for substance use disorder.

Pear Therapeutics.Clinical evidence.

Food and Drug Administration.FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs.

Morin CM.Profile of Somryst prescription digital therapeutic for chronic insomnia: overview of safety and efficacy.Expert Rev Med Devices. 2020;17(12):1239-1248. doi:10.1080/17434440.2020.1852929

Hannah Owens, LMSW

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