Neuroscience

Sleep disorder

Psychiatry

Strengths and Difficulties Questionnaire

Autism

Placebo

Alternative medicine

Pediatrics

Psychology

Insomnia

Psychotherapist

Quality of life (healthcare)

Melatonin

Mental health

Medicine

Clinical psychology

Autism spectrum disorder

Pathology

Journal of Autism and Developmental Disorders

A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2–17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2–5 mg) in improving sleep duration and onset. Treatment effects on child behavior and caregiver’s quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers’ quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers’ quality of life.

Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver’s Quality of Life