Effects of melatonin in children with attention-deficit/hyperactivity disorder with sleep disorders after

Gabriele Masi1, Pamela Fantozzi1, Arianna Villafranca1

  • 1IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Calambrone, Pisa, Italy, gabriele.masi@fsm.unipi.it.

Insights

Melatonin effectively treats sleep problems in children with attention-deficit/hyperactivity disorder (ADHD) who experience insomnia after starting methylphenidate (MPH). This safe treatment option shows positive results regardless of patient age or comorbidities.

Area of Science:

  • Pediatric Neurology
  • Sleep Medicine
  • Pharmacology

Background:

  • Methylphenidate (MPH) is a first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in children.
  • MPH treatment is frequently associated with the development of sleep disorders, impacting treatment adherence and quality of life.
  • Melatonin, known for its hypnotic and chronobiotic effects, is a potential therapeutic agent for circadian rhythm sleep disorders.

Purpose of the Study:

  • To investigate the efficacy and safety of melatonin in managing sleep problems in pediatric patients with ADHD receiving MPH.
  • To determine if patient demographics (gender, age) or comorbidities influence melatonin's effectiveness for MPH-induced sleep disturbances.

Main Methods:

  • A clinical database review of 74 children (mean age 11.6 years) treated with MPH.
  • Sleep onset delay severity was assessed using a seven-point Likert scale (Clinical Global Impression Severity score) at baseline and after 4 weeks.
  • Melatonin's effectiveness was evaluated using the Clinical Global Impression Improvement (CGI-I) score, with responders defined as those scoring 1 or 2.

Main Results:

  • A significant reduction in sleep disorder severity was observed, from 3.41 at baseline to 2.13 post-treatment (P<0.001).
  • Melatonin treatment resulted in a 60.8% response rate, with 45 patients showing significant improvement.
  • Treatment response was not influenced by gender, age, or the presence of comorbidities, including disruptive behavior, mood, anxiety, or learning disorders.

Conclusions:

  • Melatonin is a safe and effective option for managing sleep problems in children with ADHD who develop insomnia secondary to MPH treatment.
  • The benefits of melatonin are consistent across different patient subgroups, including varying ages and those with comorbidities.
  • Melatonin offers a well-tolerated therapeutic strategy, with no reported side effects in this cohort.
Abstract

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