Effectiveness of melatonin in children with attention-deficit/hyperactivity disorder who developed sleep problems after starting methylphenidate

Methylphenidate (MPH) is a first-line treatment for ADHD, but it is frequently associated with sleep-onset difficulties. This study investigated whether adding melatonin to the treatment regimen of children with ADHD who developed these sleep problems is an effective and safe strategy for improving sleep quality.

The researchers conducted a naturalistic study using a clinical database of 74 children (mean age 11.6 years) who were already receiving MPH for ADHD and subsequently developed sleep-onset delays. Patients were treated with melatonin (mean dose 1.85 mg/day) for at least four weeks. The primary outcome was the Clinical Global Impression Improvement (CGI-I) score, where a score of 1 or 2 indicated a positive response to treatment. The study also examined whether factors such as age, gender, or psychiatric comorbidities influenced the effectiveness of the melatonin.

After four weeks of melatonin treatment, 45 out of 74 patients (60.8%) were classified as responders, showing significant improvement in their sleep-onset difficulties. The effectiveness of the treatment was consistent regardless of the child's gender, age (pre-pubertal vs. adolescent), or the presence of common comorbidities such as mood disorders, anxiety, learning disabilities, or disruptive behavior disorders. Furthermore, the treatment was well-tolerated, with no reported side effects.

Sleep disturbances are a common and distressing side effect of stimulant medication in children with ADHD, often leading to the discontinuation of otherwise effective ADHD treatment. This study suggests that melatonin is a viable, safe, and effective add-on therapy that can help manage these sleep issues without requiring the cessation of MPH. By addressing sleep problems, clinicians may improve the overall quality of life for both the child and their family, while maintaining the benefits of ADHD symptom management.