Prescription digital therapeutics are software programs, usually phone or computer apps, that FDA has cleared or authorized as medical devices to treat a condition. A clinician prescribes them, and they are meant to work alongside usual care, not replace it. FDA's November 2025 list includes apps for substance use disorder, insomnia, depression, anxiety, postpartum depression, and ADHD.

Key takeaways

  • FDA regulates these products as devices. Most mental health apps fall under 21 CFR 882.5801, a prescription-only device that delivers condition-specific behavioral therapy alongside clinician-supervised care, or 21 CFR 882.5803 for ADHD.
  • FDA's November 6, 2025 list names reSET, reSET-O, Somryst, MamaLift Plus, Rejoyn, and Daylight under 882.5801, and EndeavorRx, EndeavorOTC, and Prismira under 882.5803.
  • They are add-ons. For behavioral therapy devices under 882.5801, the rule requires labeling that says the device is not a standalone therapy and does not replace a patient's medication.
  • The evidence is mixed. A 348-child trial of EndeavorRx improved a computer-based attention test, but FDA says it may not improve symptoms such as hyperactivity.
  • Medicare has billing codes G0552 to G0554 for these devices when they are part of ongoing behavioral health care. For 2026, the codes were expanded to ADHD devices.

What is a digital therapeutic?

Companies and clinicians use several names for these products, but the idea is consistent. FDA's own regulation describes a prescription-only device that delivers a computer version of behavioral therapy for a specific condition, as an add-on to care supervised by a clinician. In plain terms, the app gives a patient access to therapy tools between visits. FDA's 2025 presentation calls this group "digital mental health therapeutics."

Which digital therapeutics has FDA cleared?

FDA's November 6, 2025 presentation lists these, with the indication abbreviated:

Under 21 CFR 882.5801 (prescription only)

  • reSET: substance use disorders, for people not on opioid replacement therapy.
  • reSET-O: to increase retention of people with opioid use disorder in outpatient treatment, alongside treatment that includes buprenorphine and contingency management.
  • Somryst: chronic insomnia.
  • MamaLift Plus: mild to moderate postpartum depression.
  • Rejoyn: major depressive disorder symptoms, for people also taking antidepressant medication.
  • Daylight: generalized anxiety disorder.

Under 21 CFR 882.5803 (ADHD)

  • EndeavorRx: to improve attention function, as measured by computer-based testing, in children ages 8 to 12 with primarily inattentive or combined ADHD.
  • EndeavorOTC: a similar indication for people 18 and older.
  • Prismira: to improve attention function in adults ages 22 to 55 with primarily inattentive or combined ADHD.

FDA notes these are not the complete indications. The first products were reviewed through the De Novo pathway, which FDA uses for new types of devices. The regulation for reSET was published on December 27, 2017. Later products were cleared through the 510(k) route, which compares a new device to an earlier one. You can search FDA's 510(k) database to check a product's status.

How are they prescribed and used?

Under 882.5801, the device is prescription only. FDA's De Novo summary says EndeavorRx is restricted to prescription use. The software lives on the patient's mobile device and can be used at home. For reSET, FDA's summary describes a 12-week prescription-only treatment for adults 18 and older who are in outpatient care under a clinician's supervision. For the other products, such as EndeavorOTC and Prismira, check the labeling for whether a prescription is required.

Because this is software, there is no tablet to run out of. The practical questions are different: whether you have a prescription, whether your plan covers it, and how you get access. Ask the prescriber how access works for the specific product.

Do digital therapeutics work?

The honest answer is that it depends on the product and the measure.

For EndeavorRx, FDA's review describes a randomized, double-blind study of 348 children ages 8 to 12 who used it for 4 weeks. Children on EndeavorRx improved more than children on a digital control on a computer-based attention measure called TOVA. FDA's indication also says patients "may not display benefits in typical behavioral symptoms, such as hyperactivity." It should be part of a broader program that may include therapy, medication, or educational programs.

For reSET, FDA's labeling limits say it was not shown to work for people whose main substance is opioids. They also say its benefit on abstinence was not studied beyond 12 weeks.

A 2025 independent perspective in npj Mental Health Research raised broader concerns. The authors report that the reSET-O trial failed to show superiority over treatment as usual for abstinence, though it helped with retention. They report that Rejoyn failed to beat its sham digital control in one analysis. They also argue that many 510(k) clearances relied on similarity to earlier devices, and they call for trials of the exact marketed product. These are the authors' views, but they are useful questions to keep in mind.

How are they covered?

Coverage depends on the payer. For Medicare, CMS has billing codes G0552, G0553, and G0554 for digital mental health treatment devices. For calendar year 2026, CMS expanded them to devices classified under 21 CFR 882.5803, the ADHD group. CMS says the billing practitioner furnishes the device as a supply, alongside ongoing behavioral health treatment under a plan of care. It will only pay for use that matches the device's FDA classification. Coverage under private insurance and Medicaid varies, so ask your plan.

What questions should I ask my clinician?

  • Which FDA-cleared product are you suggesting, and what is it meant to add to my plan?
  • What does the evidence show for someone like me?
  • Will my plan cover it, and how do I get access?
  • How long will I use it, and who reviews my progress?

For more on ADHD care, see our ADHD awareness guide and the history of ADHD medication. If your plan also includes a prescription that is hard to find, Needle phones pharmacies for you. It reports which ones say they have your exact drug, strength, and form. You can start at app.findneedle.co.

Frequently asked questions

Is a digital therapeutic the same as any health app?

No. Not every health app has FDA clearance. A cleared digital therapeutic is regulated as a medical device, and FDA's special controls include clinical data, software testing, and labeling requirements. They are also prescribed by a clinician.

Do digital therapeutics replace medication or therapy?

No. The regulation for behavioral therapy devices requires labeling that warns the device is not intended as a standalone therapy and does not replace a patient's medication. EndeavorRx's indication also says it is not meant to be used alone.

Is there an FDA-cleared digital therapeutic for ADHD?

Yes. FDA's 2025 list includes EndeavorRx for children ages 8 to 12, EndeavorOTC for people 18 and older, and Prismira for adults ages 22 to 55. Each is for primarily inattentive or combined ADHD.

Will Medicare pay for a digital therapeutic?

Medicare has codes for digital mental health treatment devices, including ADHD devices as of 2026. Payment depends on how the device is furnished and billed, so check with your clinician and plan.

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