Real-life course and effectiveness of melatonin treatment for sleep disturbances in children with autism spectrum disorder

Abstract

AbstractObjectiveMelatonin is considered the most effective pharmacological treatment for the sleep disturbances that are reported in >50% of children with autism spectrum disorder (ASD). However, real-life data about the long-term course and effectiveness of melatonin treatment in children with ASD is lacking.MethodsIn this retrospective cohort study, we assessed the adherence to melatonin treatment and its effect on sleep quality and daytime behavior in children with ASD via a parental phone questionnaire of children in the Azrieli National Center for Autism and Neurodevelopment Research (ANCAN) database. Cox regression analysis was used to assess the effect of key demographic and clinical characteristics on treatment adherence.ResultsMelatonin was recommended for ∼8% of children in the ANCAN database. These children were characterized by more severe autistic symptomatology. The median adherence time for melatonin treatment exceeded 88 months, with the most common reason for discontinuation being a lack of effectiveness (14%). Mild side-effects were reported in 14% of children, and 86%, 54%, and 45% experienced improvements in sleep onset, sleep duration and night awakenings, respectively. Notably, melatonin also improved the daytime behaviors of >28% of the children. Adherence to treatment was independently associated with improvements in night awakenings and educational functioning (aHR=0.142, 95%CI=0.036-0.565; and aHR=0.195, 95%CI=0.047-0.806, respectively).ConclusionsOur findings highlight the real-life safety and effectiveness of melatonin treatment in children with ASD. Increasing the awareness of this treatment among families and health providers will help to reduce the burden associated with sleep disturbances in children with ASD and their families.