Efficacy and safety of a novel digital cognitive behavioral therapy for insomnia application versus zolpidem: An exploratory randomized controlled trial.

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中文解读

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Original abstract

<h4>Objective</h4>To evaluate the efficacy and safety of a novel, concise 5-week digital cognitive behavioral therapy for insomnia (dCBT-I) application, "IIIP MED: Sleepy Med," compared to zolpidem.<h4>Methods</h4>This exploratory randomized controlled trial enrolled patients with chronic sleep-onset insomnia who remained symptomatic after a 4-week screening period following sleep hygiene education. Participants were randomized to either the fully unguided dCBT-I group or the zolpidem (5 mg/day) group for a 5-week treatment period, followed by a 5-week follow-up. The primary outcome was the change in subjective Sleep Onset Latency (sSOL) from baseline at Week 5. Secondary outcomes included objective sleep parameters via portable electroencephalography (EEG) and safety assessments.<h4>Results</h4>At Week 5, the mean sSOL change was -20.65 min (95% CI: [-32.05, -9.65]) in the dCBT-I group (n = 11) and -22.42 min (95% CI: [-29.37, -15.46]) in the zolpidem group (n = 13), with no significant difference between groups (p = 0.7729). At the Week 10 follow-up, the dCBT-I group (n = 9) demonstrated sustained improvement (-29.02 min, 95% CI: [-51.49, -6.54]), whereas the zolpidem group (n = 12) showed a slight recurrence of symptoms (-16.19 min, 95% CI: [-27.08, -5.31], p = 0.2634). The dCBT-I group showed significantly greater improvement in Dysfunctional Beliefs and Attitudes about Sleep at Week 10. No treatment-related adverse events occurred in the dCBT-I group, while one case of daytime somnolence was reported in the zolpidem group.<h4>Conclusion</h4>The dCBT-I application was associated with an improvement in sSOL over 5 weeks, with no statistically significant between-group difference compared with zolpidem. Furthermore, the improvement in the dCBT-I group was maintained during the 5-week post-treatment follow-up. Given the exploratory design and small sample size (N = 24), the study was underpowered, and these findings should be interpreted with caution. Larger adequately powered confirmatory trials are warranted.<h4>Trial registration</h4>jRCT2032230353.

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