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The purpose is to evaluate the effect and safety of ramelteon 8 mg/day for 8 weeks in the treatment of insomnia in patients with concurrent depression in an exploratory manner. This phase 4, open-label, exploratory study included outpatients aged 20 to < 65 years with sleep-onset insomnia and major depressive disorder taking stable antidepressant medication. Following a 1-week run-in, 26 eligible patients received ramelteon 8 mg/day plus their usual antidepressants for 8 weeks. Outcomes included sleep parameters measured by actigraphy and sleep diary, 3-Dimensional Sleep Scale (3DSS), 17-item Hamilton Rating Scale for Depression (HAM-D17), Patient Global Impression (PGI), adverse events, and body weight. Actigraphy- and diary-measured sleep latency improved at the end of ramelteon treatment (mean decrease − 6.8 and − 11.5 min, respectively), but neither change reached statistical significance in this exploratory study. Other subjective measures indicated improved sleep, including diary-measured total sleep time (mean change + 41.2 min; p = .0220) and number of nocturnal awakenings (− .4; p = .0420), and 3DSS total scores for sleep quality and quantity (p < .01). Most patients (88.5%) reported improvement in PGI. HAM-D17 total scores improved at end of treatment (mean change − 4.0; p < .0001). One patient discontinued ramelteon due to moderate somnolence. Ramelteon coadministered with antidepressants was well tolerated. Results from this exploratory study suggest that ramelteon may be effective and well tolerated in the treatment of sleep-onset insomnia in patients with concurrent depression.

Effect of ramelteon coadministered with antidepressant in patients with insomnia and major depressive disorder: an exploratory study