Big Health (Sleepio, Daylight)
Big Health
First FDA-cleared DTx for anxiety (DaylightRx) and insomnia (SleepioRx) with Medicare coverage.
Decision Summary
- Larger organizations
- Integrated Care, Multi-Site / Enterprise
- Custom pricing - contact vendor
- Enterprise pricing - contact vendor
- No listed EHR integrations
About Big Health (Sleepio, Daylight)
Big Health offers FDA-cleared prescription digital therapeutics for two of the most prevalent mental health conditions: chronic insomnia (SleepioRx) and generalized anxiety disorder (DaylightRx). SleepioRx, cleared in August 2024, delivers Cognitive Behavioral Therapy for Insomnia (CBT-I) as a 90-day treatment, with clinical trials showing 76% of patients achieve improvement. DaylightRx, cleared in September 2024, is the first FDA-cleared digital treatment for GAD, with 71% improvement rates. Both products received Medicare coverage effective January 2025 through new CMS Digital Mental Health Treatment (DMHT) G-codes - a landmark achievement for the DTx industry. Big Health's employer-focused model features utilization-based pricing with no PEPM fees, billing through PBM integration. The company raised $23.7M in February 2026 to accelerate adoption and has supported over 750,000 individuals.
Best For
- • Employers seeking clinically validated digital mental health for insomnia and anxiety
- • Health plans implementing FDA-cleared digital therapeutics
- • Health systems prescribing evidence-based insomnia and anxiety treatment
- • Benefits consultants recommending proven digital health solutions
Not Ideal For
- • Solo practitioners (enterprise/B2B model)
- • Organizations seeking comprehensive MBC platforms
- • Practices treating conditions beyond insomnia and GAD
Pricing
Utilization-based (no PEPM fees)
Compliance & Security
Always verify compliance directly with the vendor.
Target Audience
Roles
Settings
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