Related Experiment Video
Updated: Jan 27, 2026

The Adventures of Fundi Intervention Based on the Cognitive and Emotional Processing in Attention Deficit Hyperactive Disorder Patients
Published on: June 12, 2020
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.
Purpose:
Methylphenidate (MPH), the first-line medication in children with attention-deficit/hyperactivity disorder (ADHD), is associated with increased risk of sleep disorders. Melatonin has both hypnotic and chronobiotic properties that influence circadian rhythm sleep disorders. This study explores the effectiveness of melatonin in children with ADHD who developed sleep problems after starting MPH.
Patients And Methods:
This study, based on a clinical database, included 74 children (69 males, mean age 11.6±2.2 years) naturalistically treated with MPH (mean dosage 33.5±13.5 mg/d). The severity of sleep disorder (sleep onset delay) was recorded at baseline and after a follow-up of at least 4 weeks using a seven-point Likert scale according to the Clinical Global Impression Severity score. Effectiveness of melatonin on sleep (mean dosage 1.85±0.84 mg/d) after 4 weeks was assessed using a seven-point Likert scale according to the Clinical Global Impression Improvement (CGI-I) score, and patients who scored 1 (very much improved) or 2 (much improved) were considered responders.
Results:
Clinical severity of sleep disorders was 3.41±0.70 at the baseline and 2.13±1.05 after the follow-up (P<0.001). According to the CGI-I score, 45 patients (60.8%) responded to the treatment with melatonin. Gender and age (children younger and older than 12 years) did not affect the response to melatonin on sleep. Patients with or without comorbidities did not differ according to sleep response. Specific comorbidities with disruptive behavior disorders (oppositional defiant disorder or conduct disorder), affective (mood and anxiety) disorders and learning disabilities did not affect the efficacy of melatonin on sleep. Treatment was well tolerated, and no side effects related to melatonin were reported.
Conclusion:
In children with ADHD with sleep problems after receiving MPH treatment, melatonin may be an effective and safe treatment, irrespective of gender, age and comorbidities.
Related Concept Videos
Attention-Deficit/Hyperactivity Disorder
Diagnostic Criteria and Symptoms
To diagnose ADHD, symptoms must manifest before age 12 and be evident across multiple settings....
Substance Use Disorders Affecting Sleep
Understanding the concepts of physical dependence,...
REM Sleep Behavior Disorder
RBD is significantly associated with...
Treatment Strategies for Psychological Disorders
Psychological therapies focus on modifying emotions, thoughts, and behaviors through talking, interpreting, listening, rewarding, challenging, and modeling. Clinical psychologists, counselors, and social workers commonly practice psychotherapy. Clinical...
Intrinsically Disordered Proteins
Other Disorders of Digestive System

