Controlled-release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in

Flavia Cortesi1, Flavia Giannotti, Teresa Sebastiani

  • 1Department of Pediatrics and Developmental Neuropsychiatry, Center of Pediatric Sleep Disorders, University of Rome La Sapienza, Italy. flavia.cortesi@uniroma1.it

Insights

Combining melatonin with cognitive-behavioral therapy appears more effective for treating sleep disorders in children with autism spectrum disorder (ASD). This combination showed a trend towards better outcomes and fewer dropouts compared to individual treatments or placebo.

Area of Science:

  • Pediatric Sleep Medicine
  • Autism Spectrum Disorders (ASD) Research
  • Behavioral Therapy and Pharmacology

Background:

  • Sleep disturbances are common in children with autism spectrum disorders (ASD), impacting their quality of life.
  • Both melatonin and cognitive-behavioral therapy (CBT) have demonstrated effectiveness in managing pediatric sleep issues.
  • Limited research exists on the comparative or synergistic effects of melatonin and CBT for ASD-related sleep disorders.

Purpose of the Study:

  • To evaluate the relative and combined efficacy of controlled-release melatonin and cognitive-behavioral therapy (CBT) in children with ASD.
  • To assess treatment outcomes for sleep onset insomnia and impaired sleep maintenance in this population.

Main Methods:

  • A randomized controlled trial involving 160 children (aged 4-10 years) with ASD and sleep onset insomnia/impaired sleep maintenance.
  • Participants were assigned to four groups: combination melatonin/CBT, melatonin alone, CBT alone, or placebo, for 12 weeks.
  • Treatment response was measured using actigraphy, sleep diaries, and questionnaires, assessing sleep latency, total sleep time, wake after sleep onset, and number of awakenings.

Main Results:

  • All active treatment groups showed significant improvements in sleep parameters from baseline to 12 weeks.
  • Melatonin primarily reduced insomnia symptoms, while CBT slightly improved sleep latency.
  • The combination therapy group exhibited a trend towards superior outcomes, with fewer dropouts and a higher proportion of responders meeting clinical significance criteria (>85% sleep efficiency, <30 min sleep onset latency).

Conclusions:

  • Adding cognitive-behavioral therapy to melatonin treatment may enhance treatment response in children with ASD experiencing sleep disorders.
  • The combination approach shows promise for improving sleep efficiency and reducing sleep onset latency in the short term.
  • Further research is warranted to confirm the long-term benefits and optimal integration of behavioral and pharmacological interventions for pediatric ASD sleep issues.

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