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# FDA OKs Somryst Prescription Digital Therapeutic
- URL: https://www.fdaweb.com/fda-oks-somryst-prescription-digital-therapeutic/
- Published: 2020-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:08:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146428

FDA has authorized Pear Therapeutics’ Somryst nine-week prescription digital therapeutic to treat patients age 22 and older with chronic insomnia. Pear [says](https://www.marketwatch.com/press-release/pear-therapeutics-obtains-fda-authorization-for-somrysttm-a-prescription-digital-therapeutic-for-the-treatment-of-adults-with-chronic-insomnia-2020-03-26?tesla=y&ref=fdaweb.com) it is the first product submitted through FDA’s 510(k) pathway and simultaneously reviewed through the agency’s software precertification pilot program.

Somryst reportedly can be used on a smartphone or tablet to deliver digital cognitive behavioral therapy including algorithm-driven sleep restriction and consolidation recommendations, providing patients with treatment when and where they need it.

The company’s submission to FDA was supported by two clinical trials that demonstrated in patients in the treatment arm clinically meaningful improvements in insomnia severity, sleep onset latency, and wake after sleep onset at the end of treatment as well as at six and 12 months.