Digital treatment for insomnia receives FDA clearance

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The U.S. Food and Drug Administration has cleared the first prescription-based digital therapeutic for the treatment of chronic insomnia in adults, according to a press release from the product developer, Pear Therapeutics. Somryst, formerly SHUTi, uses cognitive behavioral therapy and data-based sleep restrictions to treat insomnia.

Somryst uses app technology to provide CBT-I including customized sleep restriction and consolidation recommendations, stimulus control and cognitive restructuring. The company states that it also includes a physician dashboard to track patients’ sleep metrics and progress.

The company reports that Somryst was evaluated in two randomized controlled trials of more than 1,400 adults with insomnia. One trial among 303 patients showed clinically meaningful improvements in the severity of insomnia, sleep onset latency and wake after sleep onset. A second study of 1,149 patients with chronic insomnia and depressive symptoms saw a significant reduction in insomnia severity measurements over one year.

AASM Recommendations for CBT-I

According to the AASM’s Clinical Guideline for the Evaluation and Management of Chromic Insomnia in Adults, CBT-I is recommended as the standard of care for insomnia. The guideline describes behavioral treatments such as sleep restriction and stimulus control as methods to change patients’ beliefs and expectations about sleep.

Read more sleep industry news from the AASM.


American Academy of Sleep Medicine




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