The US Food and Drug Administration (FDA) has granted clearance to Big Health’s DaylightRx, a digital treatment for generalised anxiety disorder (GAD).
DaylightRx is a prescription digital therapeutic that delivers cognitive behavioural therapy (CBT) techniques to patients aged 22 years and above, aiming to improve GAD symptoms alongside usual care.
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It employs a digital formulation of CBT to teach patients techniques for managing chronic worry and anxiety.
The programme includes interactive lessons and guided practice exercises on applied relaxation, stimulus control, cognitive restructuring, and exposure to help integrate these methods into daily life.
Available through a licensed healthcare provider, the treatment spans 90 days.
Clinical trials have shown DaylightRx to be effective in treating GAD, with remission rates exceeding 70% and significant reductions in anxiety lasting six months or more.
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By GlobalDataThis clearance follows Big Health’s recent FDA approval of SleepioRx for insomnia disorder and comes at a time when the 2025 Medicare Physician Fee Schedule has proposed funding FDA-cleared digital mental health treatments, potentially broadening access to these innovative therapies.
DaylightRx builds upon Big Health’s existing digital care programme, Daylight, which has been supporting individuals for over five years.
Big Health plans to continue offering Daylight, alongside its suite of clinically-proven digital care programmes.
Big Health CEO Yael Berman said: “For too long, patients seeking non-drug treatment options for anxiety have had limited choices.
“Now, with our FDA-cleared treatment, we’re offering a powerful alternative with remission rates of over 70%. With this clearance, there is now an accessible non-medication option that patients can trust.”
