A Pilot Randomised Controlled Trial of Sublingual Melatonin for Sleep Onset Insomnia in Children With Foetal Alcohol Spectrum Disorder (FASD).

AIM: Children with foetal alcohol spectrum disorder (FASD) present with significant sleep disturbance. This pilot trial aimed to examine the feasibility of conducting a larger randomised controlled trial (RCT) in this population and the potential effectiveness of melatonin to treat onset insomnia.

METHODS

Children with sleep onset delay and a designation of 'at risk' of FASD or a diagnosis of FASD were recruited to a 10-week, double-blind, placebo-controlled, crossover study of melatonin. Sleep outcomes were assessed using actigraphy. The child sleep habit questionnaire (CSHQ) and measures of executive functioning and carer stress were completed at baseline and after each treatment phase.

RESULTS

Fifty-nine children were assessed for eligibility, 18 were ineligible as they were taking sleep medication, and eight children entered the trial. Four received melatonin for 3 weeks followed by placebo for 3 weeks (arm A) and four received placebo followed by melatonin (arm B). Processes involving data collection and retention were acceptable. However, significant issues regarding recruitment were found. Quantitative measures were appropriate with significant reductions in sleep onset latency (n = 6) in the melatonin condition relative to the placebo condition (p = 0.003), and bedtime resistance (n = 8) according to the CSHQ (p = 0.004). No serious adverse events were reported.

CONCLUSIONS

A randomised crossover design was feasible in this population; however, recruitment should be conducted across multiple sites. Melatonin is potentially effective at reducing sleep onset latency and behaviour difficulties at bedtime in children with or 'at risk' of FASD.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (12619001360101).