Big Health, a developer of digital treatments for mental health issues, has received approval from the US Food and Drug Administration (FDA) for its flagship product, SleepioRx.
Designed to address chronic insomnia and insomnia disorder, SleepioRx is a digital therapeutic that complements standard care for adults aged 18 and older.
It is based on Big Health’s existing digital care programme, Sleepio, which provides support to those struggling with sleep.
Sleepio is a prescription device that provides Cognitive Behavioural Therapy for Insomnia (CBT-I) and can be prescribed by a licensed healthcare provider.
SleepioRx addresses insomnia disorder by employing evidence-based methods that target the cognitive and behavioural factors contributing to persistent sleep issues.
The treatment personalises the patient experience by adapting to symptoms and daily sleep patterns.
In addition, the product offers real-time support to aid in falling asleep. The digital therapeutic programme is designed as a 90-day treatment.
Big Health CEO Yael Berman said: “The FDA’s clearance of SleepioRx is a landmark milestone for Big Health and provides accessible, guideline-recommended, first-line treatment for insomnia.
“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.”
The digital treatments developer has evaluated SleepioRx in over 25 clinical trials.
As per the results from these studies, the therapeutic was found effective in managing chronic sleep issues and insomnia disorder. Up to 76% of users achieved healthier sleep patterns with SleepioRx.
Participants reported up to a 54% reduction in the time it takes to fall asleep, 62% less time spent awake during the night, and a 45% improvement in daytime functioning.
Long-term follow-up shows that the benefits of SleepioRx persist, with continued improvements in sleep up to three years after treatment.
Additionally, sleep technology has demonstrated effectiveness across racially and socioeconomically diverse populations through longitudinal research conducted in collaboration with the Henry Ford Health System.
The 2025 Medicare Physician Fee Schedule proposed rule suggests covering FDA-cleared digital mental health treatments. This could expand access to SleepioRx and similar digital therapies.
In January 2022, the digital therapeutics company raised $75m in a Series C funding round to support further growth and development.
