The U.S. Food and Drug Administration (FDA) has Daylight RxDaylightRx is a prescription digital therapeutic that delivers cognitive behavioral therapy to treat Generalized Anxiety Disorder (GAD) in patients 22 years of age and older. DaylightRx is the first FDA-approved digital therapeutic for GAD. The digital therapeutic is prescribed by a licensed healthcare provider to be used as an adjunct to usual care.1
In randomized controlled trials, DaylightRx has been demonstrated to be effective in treating GAD, with remission rates exceeding 70% and patients experiencing significant reductions in anxiety for up to six months or more.2 Specifically, in an online two-arm parallel-group superiority randomized controlled trial of 256 participants with moderate to severe GAD symptoms, a digital treatment reduced anxiety symptoms compared to a wait-list control at post-intervention, reflecting a large effect size (adjusted difference). [95% CI]: 3.22 [2.14, 4.31]d = 1.08). Significant improvements were seen in several domains, including anxiety, depressive symptoms, sleep disturbance, well-being, and participant-specific quality of life. DaylightRx was delivered using participants’ personal smartphones. Online assessments were conducted at baseline, mid-intervention (week 3, from randomization), post-intervention (week 6, primary endpoint), and follow-up (week 10).
“For too long, patients seeking non-drug treatment options for anxiety have had limited options. Now, with an FDA-approved treatment, we offer a powerful alternative with a remission rate of over 70 percent. This approval means there is now a non-drug treatment option patients can trust,” Big Health CEO Yael Berman said in a press release.
DaylightRx works by teaching patients evidence-based techniques over the course of 90 days of treatment to change the thoughts and behaviors that exacerbate chronic worry and anxiety. There are interactive lessons on relaxation applications to reduce tension, stimulus control to reduce the frequency of worry, cognitive restructuring to break the spiral of anxious thoughts, and exposure to reduce the intensity of worry. DaylightRx also includes guided exercises to show patients how to incorporate these techniques into their daily lives.
Big Health also had a company that received FDA approval for the insomnia treatment SleepioRx last year. It’s worth noting that the 2025 Medicare Physician Fee Schedule includes payment proposals for FDA-approved digital mental health treatments, establishing a path to expand access to DaylightRx, SleepioRx and other digital treatments.
What digital therapeutics are you using in your practice? Let us know at [email protected].
References
1. U.S. FDA Grants Clearance for DaylightRx. Big Health. News Release. September 4, 2024. Accessed September 5, 2024. https://www.bighealth.com/news/us-fda-grants-clearance-for-daylightrx
2. Carl JR, Miller CB, Henry AL, et al. Efficacy of digital cognitive behavioral therapy for moderate to severe symptoms of generalized anxiety disorder: A randomized controlled trial. Reduce anxiety2020;37(12):1168-1178.
