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

Abstract

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.

The Case for the Patient-Centric Development of Novel Digital Sleep Assessment Tools in Major Depressive Disorder

“…A common approach is the investigation of the effect of targeted sleep treatment in patients suffering from a primary diagnosis of MDD. One such example is the use of sleep actigraphy as a primary outcome in a study investigating the effect of the co-administration of ramelteon with an antidepressant in a sample of patients with a diagnosis of MDD and sleep-onset insomnia [ 46 ]. Another notable clinical trial explored the effect of targeted pharmaceutical treatment for insomnia on suicidal ideations in patients with MDD.…”