A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial

INTERVENTION: Switching brotizolam (0.25 mg/day) to eszopiclone (1‐3 mg/day) Switching brotizolam (0.25 mg/day) to suvorexant (15‐20 mg/day) CONDITION: major depressive disorder PRIMARY OUTCOME: The mean change in ISI and PSQI total scores from baseline at weeks 2 and 4. SECONDARY OUTCOME: 1. The rate of remission in ISI and PSQI at 4 weeks.; 2. The mean change in 6 components in PSQI scores from baseline at weeks 2 and 4; sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction.; 3. The mean change in BDI total scores from baseline at weeks 2 and 4.; 4. The mean change in each items scores of BDI from baseline at weeks 4.; 5. The mean change in DSST and DS scores from baseline at week 4.; 6. The mean change in GAD‐7 total scores from baseline at weeks 2 and 4.; 7. The mean change in ISI and PSQI scores for each anxiety symptom from baseline at weeks 2 and 4. INCLUSION CRITERIA: Major depressive patients with insominia unresponssive to the treatment with brotizolam for at least 2 weeks.