Host: The Japanese Pharmacological Society
Name : The 97th Annual Meeting of the Japanese Pharmacological Society
Number : 97
Location : [in Japanese]
Date : December 14, 2023 - December 16, 2023
We have developed a SaMD to implement dCBT for insomnia with the aim of promoting cognitive behavioral therapy recommended by guidelines in the treatment of insomnia. After consulting with the PMDA, we have conducted a clinical trial under the GCP ordinance. The clinical trial was conducted at several medical institutions in Japan from May 2021 for patients with insomnia according to ICSD-3 diagnostic criteria. Patients were randomized to a therapeutic app group or a sham app group, with an 8-week treatment intervention followed by a 2-week follow-up. The primary endpoint, change (mean ± SD) in the Athens Insomnia Scale (AIS), was -6.7 ± 4.4 (95% CI -7.6 to -5.8) for the treatment app versus -3.3 ± 4.0 (95% CI -4.1 to -2.5), p < 0.001, indicating a significant treatment effect. Furthermore, at 10 weeks after the intervention, the AIS values were 5.9 ± 4.0 (95% CI, 5.1 to 6.7) for the therapeutic app and 9.7 ± 4.9 (95% CI, 8.7 to 10.6) for the sham app, p < 0.001. The results of the clinical trial confirmed that the treatment effect was maintained without the side effect of rebound insomnia, a withdrawal symptom that is an issue with sleeping pills. Based on the results of the clinical trial in Japan, the product was approved as a SaMD for insomnia on February 15, 2023.
