Sleepio (SleepioRx)
Big Health
FDA-cleared CBT-I digital therapeutic for chronic insomnia with 76% improvement rate.
About Sleepio (SleepioRx)
SleepioRx (formerly Sleepio) is an FDA-cleared prescription digital therapeutic from Big Health that delivers Cognitive Behavioral Therapy for Insomnia (CBT-I) via a 90-day digital program. Cleared by the FDA in August 2024 for chronic insomnia in adults 18+, SleepioRx has demonstrated 76% patient improvement rates across 26 clinical trials including 18 RCTs. It became the first digital therapeutic to receive NICE guidance confirming clinical and cost effectiveness. Medicare coverage began January 1, 2025 through new CMS Digital Mental Health Treatment (DMHT) G-codes. SleepioRx is distributed through employer wellness programs via PBM integration with partners like Evernorth and CVS Caremark.
Best For
- • Health systems prescribing evidence-based insomnia treatment
- • Employers seeking clinically validated digital sleep health
- • Sleep medicine physicians offering non-pharmacological options
- • Primary care practices treating chronic insomnia
Not Ideal For
- • Solo practitioners (enterprise/B2B model)
- • Patients seeking consumer apps (prescription required)
- • Acute insomnia or sleep apnea treatment
Pricing
Utilization-based (no PEPM fees)
Compliance & Security
Always verify compliance directly with the vendor.
Target Audience
Roles
Settings
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Free EHR with AI assistant and measurement-based care for therapists.