Big Health scores a novel deal to bring its digital therapeutics to an entire country

During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively.

1. Qaseem, A., Kansagara, D., Forciea, M. A., Cooke, M., & Denberg, T. D. (2016). Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 165(2), 125-133.2. Riemann, D., Baglioni, C., Bassetti, C., Bjorvatn, B., Dolenc Groselj, L., Ellis, J. G., … & Spiegelhalder, K. (2017). European guideline for the diagnosis and treatment of insomnia. Journal of Sleep Research, 26(6), 675-700.3. Wilson, S., Anderson, K., Baldwin, D., Dijk, D. J., Espie, A., Espie, C., … & Sharpley, A. (2019). British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update. Journal of Psychopharmacology, 33(8), 923-947.4. King’s Technology Evaluation Centre. (2017, November 9). Overview: Health app: SLEEPIO for adults with poor Sleep: Advice. NICE. https://www.nice.org.uk/advice/mib129.5. Espie, C. A., Kyle, S. D., Williams, C., Ong, J. C., Douglas, N. J., Hames, P., & Brown, J. S. (2012). A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep, 35(6), 769-781.6. Carl, J. R., Miller, C. B., Henry, A. L., Davis, M. L., Stott, R., Smits, J. A., … & Espie, C. A. (2020). Efficacy of digital cognitive behavioral therapy for moderate‐to‐severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depression and Anxiety, 37(12), 1168-1178.

DOC-3046 Effective 11/2023