[Treatment with ramelteon for sleep disturbance in severely disabled children and young adults].

Objective: The 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.

Methods: Eleven 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.

Results: Ramelteon was effective in 8 out of the 11 patients. Ramelteon was tolerated well except for mild daytime sleepiness in three patients.

Conclusions: This 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.