Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders.

ABSTRACT:

Background

Clinical evidence is required about the long-term efficacy and safety of melatonin treatment for sleep problems in children with neurodevelopmental disorders (NDDs) who underwent adequate sleep hygiene interventions.

Methods

We conducted a 26-week, multicenter, collaborative, uncontrolled, open-label, phase III clinical trial of melatonin granules in children 6 to 15 years of age who had NDDs and sleep problems. The study consisted of the 2-week screening phase, the 26-week medication phases I and II, and the 2-week follow-up phase. Children received 1, 2, or 4 mg melatonin granules orally in the medication phases. Variables of sleep status including sleep onset latency (SOL), aberrant behaviors listed on the Aberrant Behavior Check List-Japanese version (ABC-J),

SUBMITTER: Yuge K 

PROVIDER: S-EPMC7488027 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature