Real‐world, open‐label study to evaluate the effectiveness of mirtazapine on sleep quality in outpatients with major depressive disorder

Introduction The objective of this study was to evaluate the effect of mirtazapine on sleep quality in real-world outpatients with major depressive disorder (MDD). Methods Demographic characteristics of MDD outpatients were collected and the Pittsburgh Sleep Quality Index (PSQI) was assessed before and after treatment. Results In 3,924 MDD outpatients after treatment, sleep efficiency was significantly higher (P < 0.001), global PSQI score was significantly lower (P < 0.01), the reduction rates of sleep latency (P < 0.01) and global PSQI score (P < 0.001) were notably higher, and the proportion of using sleep medications (P < 0.05) was significantly lower in the mirtazapine group. In 3,455 MDD outpatients with insomnia after treatment, the reduction of sleep latency (P < 0.001), the prolongation of sleep duration (P < 0.001), and the increase in habitual sleep efficiency (P < 0.001) were more obvious, the reduction rates of sleep latency (P < 0.05) and global PSQI score (P < 0.001) were significantly higher, and the proportion of using sleep medications (P < 0.001) was significantly lower in the mirtazapine group. In 469 MDD outpatients without insomnia after treatment, the reduction of sleep latency (P < 0.05), the increase in sleep duration (P < 0.001) and habitual sleep efficiency (P < 0.001), and the reduction rate of global PSQI score (P < 0.05) were significantly greater in the mirtazapine group. Discussion This real-world study suggests that mirtazapine improves sleep quality of MDD outpatients, and decreases the concomitant use of sleep medications.