Big Health (Sleepio, Daylight)

Big Health

First FDA-cleared DTx for anxiety (DaylightRx) and insomnia (SleepioRx) with Medicare coverage.

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

HIPAAYes
BAA AvailableYes
SOC 2Unknown
HITRUSTUnknown

Always verify compliance directly with the vendor.

Target Audience

Roles

PsychiatristPsychologist

Settings

Integrated CareMulti-Site / Enterprise

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