STAT+: Big Health gets FDA nod for its digital therapy for insomnia

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 Somrytst, which was acquired by Nox Health after Pear filed for bankruptcy in 2023.

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