Digital therapeutics have been at the center of increasing attention in the field of medicine over the past decade. In the field of sleep disorders, digital therapeutics for insomnia are the most actively developed, and have demonstrated their efficacy through clinical trials. Digital therapeutics for insomnia have been certified by regulatory or equivalent national body, including the United States and the United Kingdom, are being actively used in medical settings. In Korea, two digital therapeutics for insomnia received approval from the Ministry of Food and Drug Safety in the year of 2023. While the efficacy of digital therapeutics for insomnia proved their efficacy through clinical trials including real-world evidence, issues regarding adherence, digital literacy, cybersecurity, and integration into the healthcare industry need to be addressed. Sleep Medicine and Psychophysiology 2024; 31(1):22-28
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