A prescription digital therapeutic for ADHD is a game-style software program that the FDA has cleared to improve attention function, for a stated age group and with a stated prescription status. A wellness app can look similar on a screen. Per the FTC’s health products guidance, the FDA has primary responsibility for claims in labeling and the FTC has primary responsibility for claims in advertising, and a product’s ads must be truthful and substantiated whatever its FDA status. This guide covers what each cleared product is for, what the studies found, and how to check the exact product before you decide.
What is digital therapeutics (DTx)?
Digital therapeutics, often shortened to DTx, are software applications for clinical use. AmeriHealth Caritas Next’s AmeriHealth Caritas Next clinical policy describes them that way and says they have been proposed to improve attention problems. A PubMed-indexed review describes digital therapeutics for ADHD as an emerging complementary option to psychosocial interventions (the PubMed review of EndeavorRx and related apps).
The U.S. Substance Abuse and Mental Health Services Administration has also published an advisory that introduces digital therapeutics and their use in behavioral health. It covers the research, regulatory and reimbursement issues, plus selection and implementation considerations (SAMHSA’s advisory on digital therapeutics).
Examples of digital therapeutics for ADHD
- EndeavorRx, a video game that the policy says is indicated for children ages 8 to 17 and available by prescription only.
- EndeavorOTC, which the policy says is indicated for people 18 and older and available over the counter.
- Prismira, a game app that the policy says is indicated for ages 22 to 55 and available by prescription only. The policy says Prismira is now marketed as LuminosityRx.
How do digital therapeutics work?
The programs are built around a game. The STARS-ADHD trial describes its product, AKL-T01, as an investigational digital therapeutic designed to target attention and cognitive control through a video game-like interface (the STARS-ADHD trial record on PubMed). The AmeriHealth policy identifies that trial as the primary study behind EndeavorRx.
A second study, indexed on PubMed in 2021, takes a neuroscience angle. Its authors say there is growing evidence that modulating the brain circuits related to attention can improve behavior, and they used game-based programs aimed at a brain signal called midline frontal theta, which they describe as a key neural marker of attention (the 2021 PLoS One study). In plain terms, the game is designed to engage attention, and the studies measure both attention test results and that brain signal before and after the program.
How is a prescription digital therapeutic different from a wellness app?
The main difference is the regulatory record behind the product. A cleared prescription program has an FDA record that names its use. A wellness or brain-training app has no such clearance for its health claims, so its ads carry the claims. The FTC says health claims must be supported by competent and reliable scientific evidence, and that the same principles apply to any health-related product. The FTC has settled or adjudicated more than 200 cases about false or misleading health claims since 1998, and those cases include health-related apps (the FTC’s health products compliance guidance).
| Question | Prescription digital therapeutic | Wellness or brain-training app |
|---|---|---|
| What it rests on | An FDA 510(k) clearance for a named use, age group and prescription status | Advertising claims, which the FTC says need competent and reliable scientific evidence |
| Published evidence | Controlled trials in children, such as STARS-ADHD (2020) | For computer-based brain-training apps, the National Institute on Aging says there is not enough evidence that they have the same impact on cognitive abilities as the ACTIVE study’s training. That statement is about older adults’ memory and thinking. |
When a product’s ad says more than its FDA record lists, the FTC guidance is clear that the health claim needs its own scientific support. Ask the maker for that support in writing.
Which outcomes are authorized by the FDA?
According to AmeriHealth Caritas Next’s clinical policy, the FDA has issued 510(k) clearance to three digital therapeutic devices to improve attention function in people with primarily inattentive or combined type ADHD. The policy says these devices are used as part of a program that may include clinician-directed therapy, medication, and/or educational programs. It also says patients may show improved attention without benefits in other symptoms such as hyperactivity.
| Product (name as the policy gives it) | Ages | How it is obtained | FDA 510(k) record | Date |
|---|---|---|---|---|
| EndeavorRx | 8 to 17 | Prescription only | K231337, summary approval letter | Decision date December 14, 2023 |
| EndeavorOTC | 18 and older | Over the counter | K233496, summary approval letter | Decision date June 14, 2024 |
| Prismira (now marketed as LuminosityRx) | 22 to 55 | Prescription only | K243729, summary approval letter | Date prepared June 15, 2025 |
As of October 30, 2026, these are the letters the policy cites. Check the FDA record for the exact product and its current version before you rely on any row.
What does the research show?
The strongest studies cited in these sources are in children. The table covers the trials and review that the sources describe.
| Study | Who was studied | What changed | Scope and limits |
|---|---|---|---|
| STARS-ADHD randomized controlled trial, The Lancet Digital Health, 2020 | 348 children aged 8 to 12 with confirmed ADHD and no disorder-related medication, out of 857 evaluated across 20 US research institutions | Mean change on the TOVA attention score was 0.93 for the AKL-T01 group and 0.03 for the control group | Sponsored by Akili Interactive Labs. The authors say future research is needed. |
| 2021 PLoS One clinical trial | 25 children aged 8 to 12 with ADHD, measured before and after a four-week at-home program on an iPad | The brain signal, objective attention tests and parent-reported symptoms all improved | Measures were taken before and after in the same children. Registered as NCT03844269. |
| Systematic review of serious games, 2025 | 35 studies with 1,408 participants, all children with ADHD, published between 2010 and January 2024 | The review says evidence suggests serious games may contribute to improvements in attention, hyperactivity-impulsivity, social skills and executive functions. Motor-skill findings were inconclusive. | Children only. The review’s authors say the findings support the potential of serious games as a digital therapeutic. |
AmeriHealth Caritas Next’s policy weighs this wider evidence more cautiously. It says EndeavorRx appears safe and well tolerated and offers short-term improvement in inattention and hyperactivity, but that its effectiveness in real-world settings and over the long term is unclear. It also says low evidence quality limits conclusions about effectiveness for digital interventions generally, and that Prismira, to date, has no independently published studies supporting its clinical use. The policy also cites a 2024 meta-analysis that found medication had outcomes superior to digital therapeutics for inattention and hyperactivity-impulsivity.
What are the side effects?
In the STARS-ADHD trial, the authors reported no serious adverse events and no discontinuations. Treatment-related adverse events were mild: frustration in 5 of 180 children (3%) and headache in 3 of 180 (2%) in the AKL-T01 group. The AmeriHealth policy reports that intervention-emergent adverse effects happened in 7% of the test group (12 children) and 2% of controls (3 children). Ten of those 12 effects were frustration, headache and emotional reaction. These figures come from trials that ran for a few weeks, and the policy says future research should address safety assessments.
The age and prescription rows in the table above show who each product is cleared for. If you fall outside that range, ask your clinician whether a digital therapeutic fits your situation.
Is a digital therapeutic covered by insurance, and what does it cost?
AmeriHealth Caritas Next’s clinical policy classifies EndeavorRx and Prismira as investigational and not medically necessary under its plan, and it lists medication (stimulants and non-stimulants) and behavior management as alternative covered services. The policy also says that plan benefits control if they conflict with the policy. Coverage therefore depends on your own plan. The policy also says current guidelines for treating pediatric ADHD do not include digital therapeutics.
Prices and bundles change, so check today’s price directly with the maker, and check coverage with your plan before you assume a cost.
What should I do before I choose?
Use these steps to verify the right device or tool for you:
- Get the exact product name and its FDA 510(k) number from the maker or your prescriber.
- Open the FDA letter for that number and read the stated use, age range and prescription status.
- Compare that stated use with what the product’s ads promise.
- Ask your clinician whether a digital therapeutic fits alongside your current care. The AmeriHealth policy lists medication and behavior management as alternative covered services. For related reading, see our guides on parent training for ADHD and neurofeedback for ADHD.
If you are weighing medication, our guide on atomoxetine for ADHD covers one medication’s benefits and side effects.
Before you order
- The exact product name and its FDA 510(k) number.
- The age range and prescription status for your situation.
- Whether your plan covers it.
- Today’s price, checked directly with the maker.
- The maker’s refund terms, requested in writing before you pay.
As of October 30, 2026, the FDA clears these products through its 510(k) process, and the linked letters are its records for the three products above. The FTC’s Health Products Compliance Guidance, as of October 5, 2026, explains how advertising law applies to health claims for apps and other products. This is information, not legal advice.
By the Global MH Summit Research Team
This article is for general information purposes only and does not constitute medical advice. Consult your doctor or qualified healthcare provider before making changes to your health routine.