Summary: The US Food and Drug Administration (FDA) has cleared SleepioRx, a digital therapeutic developed by Big Health for the treatment of chronic insomnia. SleepioRx employs cognitive behavioral therapy for insomnia (CBT-I) to address the cognitive and behavioral factors that sustain insomnia. The therapeutic has demonstrated efficacy in clinical trials, showing up to 76% of patients achieving healthy sleep and continued improvements up to three years post-treatment.
Key Takeaways:
- FDA Clearance: The FDA has cleared SleepioRx, a prescription digital therapeutic for chronic insomnia.
- Efficacy: Clinical trials have shown SleepioRx to be highly effective, with up to 76% of patients achieving healthy sleep and substantial reductions in time to fall asleep and time spent awake at night.
- Long-Lasting Benefits: Follow-up data indicates that the benefits of SleepioRx are long-lasting, with participants continuing to experience improved sleep quality up to three years after treatment.
Big Health, a developer of digital treatments for mental health conditions, has been granted clearance by the US Food and Drug Administration (FDA) for its flagship digital therapeutic, SleepioRx.
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. Sleepio is a prescription device delivering cognitive behavioral therapy for insomnia and can be made available on the order of a licensed healthcare provider.
SleepioRx treats insomnia disorder by delivering evidence-based techniques targeting the cognitive and behavioral factors that maintain insomnia and chronic sleep problems. Patient experience is tailored based on symptoms and daily sleep tracking. In addition to core therapeutic components, there is in-the-moment therapeutic content for help falling asleep. SleepioRx is a 90-day treatment.
Efficacy of Sleepio Digital Therapeutic
SleepioRx has been evaluated in over 25 clinical trials and demonstrated efficacy in addressing chronic sleep issues and insomnia disorder, with up to 76% of patients achieving healthy sleep. Participants using SleepioRx have experienced up to 54% reduction in time to fall asleep, spent 62% less time awake at night, and were 45% better functioning the next day.
Follow-up data indicate that the benefits conferred by SleepioRx are long-lasting, with participants continuing to experience improvements in sleep up to three years after using SleepioRx. SleepioRx has demonstrated effectiveness in racially and socioeconomically diverse samples through longitudinal research in partnership with the Henry Ford Health System.
The 2025 Medicare Physician Fee Schedule proposed rule included a proposal to pay for FDA-cleared digital mental health treatments. This establishes a promising pathway to scale access to SleepioRx and similar digital therapeutics that are deployed in clinical practice and can help address the significant unmet mental health need nationwide.
“The FDA’s clearance of SleepioRx is a landmark milestone for Big Health and provides accessible, guideline-recommended, first-line treatment for insomnia,” says Big Health CEO Yael Berman in a release. “This clearance, coupled with the new proposed reimbursement codes, will for the first time motivate US healthcare providers to prescribe safe and effective treatment alternatives to traditional medication.”
SleepioRx was developed based on Big Health’s existing digital care program, Sleepio, which has been providing support to those with sleep difficulties for over a decade. Big Health will continue to offer Sleepio and its broader suite of clinically proven digital care programs to millions of members covered by employers, health plans, and international health systems.
Photo caption: SleepioRx
Photo credit: Big Health
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