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Clinical Trial
[Treatment with ramelteon for sleep disturbance in severely disabled children and young adults].
- Akie Miyamoto, Ikue Fukuda, Hajime Tanaka, Ryuuji Oka, Akiko Araki, and Kazuhiko Cho.
- Department of Pediatrics, Asahikawa Habilitation Center for Disabled Children, Asahikawa, Hokkaido. akiem@potato4.hokkai.net
- No To Hattatsu. 2013 Nov 1; 45 (6): 440-4.
ObjectiveThe aim of this study was to determine the efficacy and safety of ramelteon for severely disabled children and young adults who had already been treated for sleep disturbance with melatonin at a dose of 3 mg.MethodsEleven patients, who were aged between 3-25 years and included 4 patients with cerebral palsy, -took 3-8 mg of ramelteon at bedtime, after a one-week of washout period. Sleep states were evaluated using sleep diaries recorded by caregivers or using actigraphs.ResultsRamelteon was effective in 8 out of the 11 patients. Ramelteon was tolerated well except for mild daytime sleepiness in three patients.ConclusionsThis preliminary study showed the efficacy and safety of ramelteon for sleep disturbance in severely disabled children and young adults. Further trials are necessary to determine optimal dosage and safety of ramelteon in children.
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