FDA clears SleepioRx digital therapeutic for insomnia treatment

Big Health has achieved a significant milestone with the FDA granting clearance for its flagship digital therapeutic, SleepioRx. Announced on August 8, 2024, this clearance marks a pivotal step in treating chronic insomnia in adults aged 18 and older. SleepioRx is designed to be used as an adjunct to usual care under the guidance of a licensed healthcare provider.

Chronic insomnia, affecting approximately 25% of adults in the United States, imposes an estimated $62.3 billion annual cost on the US industry. The condition is not only a significant economic burden but also a major contributor to a range of health issues, including diabetes, obesity, heart disease, cancer, stroke, and dementia. The introduction of SleepioRx offers a promising new avenue for addressing these widespread health concerns.

SleepioRx delivers cognitive behavioral therapy for insomnia (CBT-I), an evidence-based treatment that targets the cognitive and behavioral factors maintaining chronic sleep problems. Tailored to individual patient needs, SleepioRx integrates daily sleep tracking to personalize the therapeutic experience. The 90-day treatment program also includes in-the-moment therapeutic content to assist patients in falling asleep.

Clinical evaluations of SleepioRx have been extensive, with over 25 clinical trials demonstrating its efficacy in treating chronic insomnia. Results from these studies are promising:

• up to 76% of patients achieved healthy sleep patterns
• participants experienced up to a 54% reduction in time to fall asleep

Additionally, patients spent 62% less time awake at night and reported a 45% improvement in daytime functioning. Notably, these benefits are long-lasting, with improved sleep quality persisting for up to three years post-treatment.

The effectiveness of SleepioRx has been validated across racially and socioeconomically diverse populations, thanks to longitudinal research conducted in partnership with the Henry Ford Health System. This broad applicability is crucial as healthcare providers seek to address the unmet need for effective mental health treatments across diverse patient groups.

The recent 2025 Medicare Physician Fee Schedule proposal to pay for FDA-cleared digital mental health treatments could further enhance access to SleepioRx. This move by the Centers for Medicare & Medicaid Services (CMS) establishes a promising pathway for scaling the reach of digital therapeutics like SleepioRx within clinical practice, potentially revolutionizing the landscape of mental health treatment.

"The FDA's clearance of SleepioRx is a landmark milestone for Big Health and provides accessible, guideline-recommended, first-line treatment for insomnia,” said Yael Berman, CEO of Big Health, in the press 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 is built upon the success of Big Health’s existing digital care program, Sleepio, which has been delivering accessible and effective sleep support for over a decade. Big Health plans to continue offering Sleepio and its broader suite of clinically proven digital care programs to millions of members covered by employers, health plans, and international health systems.

As Big Health moves forward, the FDA clearance of SleepioRx and the potential reimbursement opportunities promise to expand the reach and impact of digital therapeutics in addressing chronic insomnia, providing patients with more accessible and effective treatment options.