US FDA Grants Clearance for SleepioRx

Aug 8, 2024 (San Francisco, CA): Big Health, the leading developer of digital treatments for the most common mental health conditions, has been granted clearance by the U.S. 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 (CBT-I) 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. 

Approximately 25% of adults in the U.S. suffer from insomnia, with a cost to U.S. industry of $62.3 billion per year.¹ Poor sleep has also been associated with increased risk for a number of health conditions, including diabetes, obesity, heart disease, and cancer. Individuals who do not get sufficient sleep are also at higher risk of stroke or dementia.²

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 3 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 nation-wide. 

"The FDA's clearance of SleepioRx is a landmark milestone for Big Health and provides accessible, guideline-recommended, first-line treatment for insomnia." Big Health CEO Yael Berman emphasizes, "This clearance, coupled with the new proposed reimbursement codes, will for the first time motivate U.S. 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 accessible, effective support to those struggling with sleep 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. 

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About Big Health

Big Health’s mission is to help millions back to good mental health by providing digital treatments and programs for the most common mental health conditions, including insomnia, anxiety, and depression. Designed by leading experts, Big Health’s clinically proven programs expand access to gold standard behavioral techniques and are backed by over 90 industry-leading research publications and 18 randomized controlled trials. Big Health has been partnering with employers, health plans, and international health systems for over a decade to provide inclusive, scalable, and affordable mental health care.

1. Insomnia costing U.S. workforce $63.2 billion a year in lost productivity, study shows. (2011, September 1). American Academy of Sleep Medicine – Association for Sleep Clinicians and Researchers. 

2. Winer JR, Deters KD, Kennedy G, et al. Association of Short and Long Sleep Duration With Amyloid-β Burden and Cognition in Aging. JAMA Neurology. Published online August 30, 2021. doi:https://doi.org/10.1001/jamaneurol.2021.2876