A cognitive behavioural therapy (CBT) app designed by the California-based Big Health to combat insomnia has secured clearance from the US Food and Drug Administration (FDA).
A 90-day treatment, SleepioRX tailors itself based on symptoms and daily sleep tracking. Now, the FDA has granted the app approval in the US to enter a global market estimated by GlobalData to be worth approximately $3.22bn last year.
Big Heath claims that the approval comes following more than 25 clinical trials and has demonstrated its efficacy in addressing chronic sleep issues, as well as insomnia disorder, with 76% of patients achieving some form of healthy sleep.
The therapeutic version of the app, SleepioRX, is an iteration of its non-clinical app, Sleepio, and is available on prescription.
Research published in the Journal of the American Medical Association (JAMA) details how approximately 25% of adults in the US have suffered from some form of insomnia, with the indication associated with an increased risk factor for conditions such as stroke or dementia.
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 announcement follows after the UK’s National Institute of Health and Care Excellence (Nice) recommended the use of SleepioRX as an alternative to sleeping pills after clinical evidence showed that the Sleepio app has been comparatively more effective at reducing insomnia.
In July 2023, the company acquired depression therapeutic app developer, Limbix, for an undisclosed amount.
Research by GlobalData shows the telemedicine and virtual care market has seen a significant leap in terms of usage and value since the Covid-19 pandemic, with the market reaching $690m in 2015, and projected to reach $3.8bn by 2030 with mental health expected to be the primary area of growth.
