FDA-Cleared Digital Treatments are Shaping the Future of Mental Healthcare

Over 130 million adults in the US and UK suffer from insomnia, anxiety, or both—yet nearly 70% are treated with prescription drugs alone. Alarmingly, over 75% of “rescue” prescriptions exceed the recommended 30-day use, despite risks of dependence. Meanwhile, fewer than 10% receive cognitive behavioral therapy (CBT), the first-line treatment backed by clinical guidelines.^1,2 This may be the most glaring case within our medical system where the widespread, ongoing practice is so divergent from what’s indicated by data and clinical guidelines. 

Digital mental health treatments (DMHTs) offer a promising path forward. Mental health is emerging as the leading use case for DMHTs due to three key factors:

1. High prevalence – Conditions like insomnia and anxiety affect 1 in 3 people.
2. Ineffective, undesired treatments – Commonly prescribed medications yield mixed results and significant side effects, while 75% of patients say they would prefer a non-drug option.
3. Shifting priorities – Mental health is now a top concern for employers, health systems, and policymakers.

Big Health’s DMHTs for insomnia and anxiety – SleepioRx³ for insomnia and DaylightRx⁴ for anxiety, received FDA clearance in fall 2024. Medicare reimbursement through new CMS codes was also authorized last year for qualifying DMHTs like SleepioRx and DaylightRx. These milestones combined opened the gates to broad adoption of effective, accessible, patient-preferred treatment for the most pervasive mental health conditions. 

Since then, Big Health has been building the infrastructure to exponentially expand access to our proven digital therapies. By partnering with teletherapy providers, health systems, and provider groups, Big Health aims to deliver its FDA-cleared therapeutics at scale to make a material and positive impact for the tens of millions of people suffering from insomnia and anxiety. 

To date, nearly 500,000 people have used our solutions, which in clinical studies, have an average remission rate of over 70% across all programs.^5,6,7 Most of this usage came through employer sponsored benefit plans – which remain an important and growing access point – but massive need and demand still exist. This is about to change.

The business case for new distribution channels for Big Health’s solutions is compelling and clear, with the undeniable efficacy of prescribing FDA-cleared DMHTs. Healthcare systems and provider groups represent a key opportunity, and the integration of DMHTs into their offerings is a natural evolution. A prime example is our partnership with Henry Ford Health (HFH), which has adopted SleepioRx for insomnia patients in their primary care and sleep clinics. The challenges faced by HFH and its insomnia patients –– long wait times to see a provider, undesired side effects from medication, and limited non-drug options –– are consistent with broader patterns in healthcare.

The impact of SleepioRx on HFH patients has been significant and measurable. In phase 1 of our rollout, we saw strong adoption rates –– and anticipate even higher engagement in subsequent phases due to ongoing implementation improvements. The average time from provider order to SleepioRx program initiation was just one day. Of those offered SleepioRx, 39% chose to enroll,⁸ indicating strong patient interest compared to other treatments. For example, other digital solutions have seen enrollment rates of only 22%. Among those who enrolled in SleepioRx, 79% experienced symptom improvement.⁸ Big Health is in advanced discussions with several additional health systems, who will begin phase 1 of programs with SleepioRx and DaylightRx this year –– watch this space for announcements soon!

Telehealth/teletherapy has also become mainstream and serves as a natural access point for DMHTs, with providers increasingly recognizing that DMHTs fill a crucial gap in their offerings. As adoption grows and symptom remission improves, we anticipate that Big Health’s FDA-cleared DMHTs will be widely accepted and integrated into teletherapy programs, further enhancing patient care.

We stand at a pivotal moment in the treatment of two of the most widespread mental health challenges. Effective digital treatments combined with regulatory approval and reimbursement opportunities opens the door to revolutionize care for insomnia, anxiety, and beyond. Big Health’s mission—to bring millions back to good mental health—has never been more tangible than it is today.  By remaining steadfast with our strategy, we will reach more patients and have a real impact across key sectors of our society. We will keep you updated along the way. 

^{1. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33. doi: 10.7326/M15-2175. Epub 2016 May 3. PMID: 27136449.}

^{2. Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986. PMID: 33164742; PMCID: PMC7853203.}

^{3. SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia/insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider. Patients should read the instructions for use for full information.}

^{4. DaylightRx is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. DaylightRx is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older. Patients should read the instructions for use for full information.}

^{5. Espie, C. A., Kyle, S. D., Williams, C., Ong, J. C., Douglas, N. J., Hames, P., & Brown, J. S. (2012). A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep, 35(6), 769–781.}

^{6. Carl, J. R., Miller, C. B., Henry, A. L., Davis, M. L., Stott, R., Smits, J. A. J., Emsley, R., Gu, J., Shin, O., Otto, M. W., Craske, M. G., Saunders, K. E. A., Goodwin, G. M., & Espie, C. A. (2020). Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depression and anxiety, 37(12), 1168–1178. https://doi.org/10.1002/da.23079}

^{7. Unpublished RCT data, Dec 2023. Stat reflects a 25% improvement in scores on a validated screening measure. Screening tools alone are not sufficient to diagnose depression.} 

^{8. Internal Data. Feb 2025.}

^{DOC-3843 Effective March 2025}