Abstract
Digital therapeutics (DTx) are products that provide evidence-based interventions driven by high-quality software programs to prevent, manage, or treat a medical disease. DTx are receiving increasing attention as a new therapeutic approach. Several DTx for insomnia are on the market, some of which have received approval by national regulatory agencies. DTx for insomnia are usually based on cognitive behavioral therapy for insomnia. No DTx for other sleep disorders, such as narcolepsy or sleep-related breathing disorders, have received regulatory authority approval as a medical device. DTx have the substantial benefits of being accessible and relatively low-cost. However, several issues related to DTx have not yet been fully resolved, and discussions regarding DTx are still in the early stages. To use DTx for sleep disorders as an effective treatment option in the future, considering the current status of DTx is necessary. This review discusses definitions and background of DTx; specific DTx for insomnia that have been developed; use of DTx for sleep and related psychiatric comorbid symptoms; global regulatory processes for DTx, including prescribing and medical billing issues; and remaining challenges regarding the use of DTx.
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