Effect of ramelteon coadministered with antidepressant in patients with insomnia and major depressive disorder: an exploratory study
2019
The purpose is to evaluate the effect and safety of
ramelteon8 mg/day for 8 weeks in the treatment of
insomniain 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
insomniaand major depressive disorder taking stable antidepressant medication. Following a 1-week run-in, 26 eligible patients received
ramelteon8 mg/day plus their usual antidepressants for 8 weeks. Outcomes included sleep parameters measured by
actigraphyand
sleep diary, 3-Dimensional Sleep Scale (3DSS), 17-item
Hamilton Rating Scalefor
Depression(HAM-D17), Patient Global Impression (PGI), adverse events, and body weight.
Actigraphy- and diary-measured sleep latency improved at the end of
ramelteontreatment (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
ramelteondue to moderate
somnolence.
Ramelteoncoadministered with antidepressants was well tolerated. Results from this exploratory study suggest that
ramelteonmay be effective and well tolerated in the treatment of
sleep-onset
insomniain patients with concurrent depression.
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