A randomized, placebo‐controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities

Abstract

The purpose of this study was to determine the efficacy of controlled-release (CR) melatonin in the treatment of delayed sleep phase syndrome and impaired sleep maintenance of children with neurodevelopmental disabilities including autistic spectrum disorders. A randomized double-blind, placebo-controlled crossover trial of CR melatonin (5 mg) followed by a 3-month open-label study was conducted during which the dose was gradually increased until the therapy showed optimal beneficial effects. Sleep characteristics were measured by caregiver who completed somnologs and wrist actigraphs. Clinician rating of severity of the sleep disorder and improvement from baseline, along with caregiver ratings of global functioning and family stress were also obtained. Fifty-one children (age range 2-18 years) who did not respond to sleep hygiene intervention were enrolled. Fifty patients completed the crossover trial and 47 completed the open-label phase. Recordings of total night-time sleep and sleep latency showed significant improvement of approximately 30 min. Similarly, significant improvement was observed in clinician and parent ratings. There was additional improvement in the open-label somnolog measures of sleep efficiency and the longest sleep episode in the open-label phase. Overall, the therapy improved the sleep of 47 children and was effective in reducing family stress. Children with neurodevelopmental disabilities, who had treatment resistant chronic delayed sleep phase syndrome and impaired sleep maintenance, showed improvement in melatonin therapy.

Complementary and Alternative Medicine in Autism: An Evidence-Based Approach to Negotiating Safe and Efficacious Interventions with Families

“…Importantly, treatment was also effective in reducing family stress. 60 A cohort study demonstrated encouraging results for both safety and improvement of parentally reported sleep difficulties; adverse effects were uncommon, with either enuresis or morning somnolence reported in 3 of 107 children. 61 There have been conflicting results regarding seizures and melatonin.…”

Trends in Inpatient Pediatric Polysomnography for Laryngomalacia and Craniofacial Anomalies

“…This is likely reflective of the known associations between neurologic disease and a variety of sleep disorders, including sleep-related breathing disorders, 29 hypersomnia, 30,31 insomnia, 32 circadian rhythm sleep disorders, 33 and parasomnias. 34 Similarly, sleep disorders are also thought to be common in children with cerebral palsy.…”

Melatonin for the management of sleep disorders in children and adolescents

“…There is also evidence that melatonin may be helpful in treating sleep problems in children with intractable epilepsy (16), neurodevelopmental disabilities (17)(18)(19), and with Angelman syndrome (20).…”