Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial.

ABSTRACT:

Objective

To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders.

Design

12 week double masked randomised placebo controlled phase III trial.

Setting

19 hospitals across England and Wales.

Participants

146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours' continuous sleep.

Interventions

Immediate release melatonin or matching placebo

SUBMITTER: Gringras P 

PROVIDER: S-EPMC3489506 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature