Ever since the first case which was reported by Palm and colleagues in 1991, there have been more than two dozen papers that describe the use of melatonin in children who have sleep disturbances. Some studies were published by Jan and colleagues of the Children’s Hospital Visually Impaired Program. This takes place in the Children’s Hospital in British Columbia. It was in 1994 that they published a study consisting of 15 children with ages 6 months to 14 years old who were given melatonin for sleep disturbances. Practically all the subjects have failed to become responsive to conventional therapy which will include nonpharmacologic measures in order to improve sleep hygiene. Among the 15 children, nine of them have mental retardation, two are suffering from ADHD and nine children can either be ocular or cortical vision impairment. The study being conducted was a double-blind crossover randomized design with every child receiving melatonin at a dose of 2.5 to 5 mg or placebo during bedtime for a period of seven to ten days. After a 4 to 5 day wash-out period, it has been switched to alternative arm. The care providers of the subject were keeping sleep diaries with them. Patients who responded to the therapy remained on melatonin after the study has been completed and had follow ups at three and six months.
Among the 15 children, 13 had favorable responses to melatonin with enhancement in the sleep duration. All of the subjects have experienced clinical gain with enhanced mood and behavior at daytime. Children who have delayed sleep onset have experienced the most remarkable response. Doses ranging from 2.5 to 10 mg are considered to be effective. There are no additional benefits with higher doses or during the administration of a second dose at nighttime. Ten patients stayed on with the therapy after the study has been completed for a period of up to a year. So far, no adverse effects which could be related to melatonin were reported.
IN 1997 in order to create their first case report, Palm and colleagues published the results of an open study regarding melatonin in eight children who are blind and young adults. The age range of the patients is from 3 to 23 years old and all are suffering from significant sleep disturbances. The serum and urine concentrations of melatonin were assessed in 5 patients before the start of the treatment which reveal the delays during the time of peak concentrations which would range from 03:00 to 12:00.