Scale access to FDA-cleared mental health treatments

SleepioRx¹ and DaylightRx² are FDA-cleared digital treatments for insomnia disorder and generalized anxiety disorder, respectively, delivering guideline-recommended cognitive behavioral therapy (CBT) through video and audio lessons in mobile apps. Designed by sleep and anxiety experts, the treatments help patients understand unhealthy patterns and address the thoughts and behaviors that sustain insomnia and anxiety. CBT techniques delivered in an engaging and interactive format help patients overcome insomnia and anxiety, quickly.
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1. 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.
2. 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.

SleepioRx has been tested to the highest standards of clinical evidence in 26 clinical trials, including 18 randomized controlled trials (RCTs). Across these studies, SleepioRx outperforms rigorous controls, including sham-placebo, usual care, and sleep hygiene, with up to 76% of SleepioRx patients achieving healthy sleep by post-treatment.^1-4 Data suggest that patients continue to experience benefits 1 year or longer after starting SleepioRx.^5,6

DaylightRx has been evaluated across 2 rigorous RCTs and one single-arm trial. DaylightRx has demonstrated superiority compared to an active psychoeducation control, with 71% of DaylightRx participants achieving GAD remission based on clinical interview compared to 35% of control participants,⁷ with consistent results observed on self-reported measures.⁸ Results from these trials demonstrate that benefits conferred by DaylightRx are maintained until at least 6 months.⁷
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1. Espie et al. (2012). SLEEP, 35(6), 769-781.
2. Tamm et al. (2025). JAMA Network Open, 8(2), e2461502-e2461502.
3. Tarnai et al. (2025). Aging and Mental Health, 1-7
4. Internal RCT data, August 2023.
5. Luik et al. (2020). Journal of Sleep Research, 29(4), e13018.
6. Cheng et al. (2021). SLEEP, 44(4), zsaa258.
7. Internal RCT data, September 2023.
8. Carl et al. (2020). Depression & Anxiety, 37(12), 1168-1178.

You can place an order and start distributing SleepioRx or DaylightRx to your qualifying patients in three simple steps:
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Step 1: Big Health provides providers with a website for ordering, along with unique access codes. Print and digital referral materials are also available if needed.
Step 2: The provider identifies qualifying patients, explains SleepioRx or DaylightRx, and enters a unique access code and the patient's phone number on the website.
Step 3: The patient receives a text message with instructions for accessing, downloading and signing up for SleepioRx or DaylightRx.

The Centers for Medicare & Medicaid Services (CMS) has finalized three new Digital Mental Health Treatment (DMHT) codes in the Calendar Year (CY) 2025 Medicare Physician Fee Schedule as of January 1, 2025, allowing providers a reimbursement opportunity for prescribing DMHTs like SleepioRx and DaylightRx to Medicare patients. While we are actively engaging other insurance carriers to expand coverage, these DMHT codes are not a guarantee of reimbursement.

Licensed providers who are able to offer behavioral therapy or behavioral health care within their scope of practice can order SleepioRx or DaylightRx and bill for the codes.This includes the following practitioners:
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- Psychiatrists & other doctors (MDs, DOs)
- Clinical psychologists
- Clinical social workers (LCSWs, LICSWs)
- Advanced practice nurses/Nurse practitioners (NPs)
- Physician assistants (PAs)
- Marriage & family therapists (LMFTs)
- Mental health counselors

Check commercial payer policies for restrictions. The billing practitioner or a colleague should oversee patient care and adjust treatment as needed. They may also supervise non-qualifying practitioners in providing these services.