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

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

Already have an account? Log in

Already have an account? Log in

Individual plans

Group plans

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe

Log In