Digital Therapeutics developer Big Health this week received Food and Drug Administration clearance for SleepioRx, a prescription treatment for insomnia.
Big Health already sells a wellness version of the app, called Sleepio, to employers and health plans that make the product available to their members. The app delivers a specialized type of cognitive behavioral therapy for insomnia and the company boasts that it is backed by dozens of studies.
SleepioRx is not the first FDA-cleared insomnia digital therapeutic. Pear Therapeutics developed a product called Somryst, which was acquired by Nox Health after Pear filed for bankruptcy in 2023.
