Melatonin treatment for insomnia in pediatric patients with attention-deficit/hyperactivity disorder
1Department of Pharmacy, Duke University Hospital, Durham, NC, USA. isa.m.bendz@gsk.com
Insights
Melatonin effectively treats sleep-onset insomnia in pediatric patients with ADHD. This well-tolerated option shows mild adverse events, but larger trials are needed for optimal dosing and long-term safety.
Area of Science:
- Pediatric Sleep Medicine
- Neurodevelopmental Disorders
- Pharmacology
Background:
- Pediatric insomnia is common in children with attention-deficit/hyperactivity disorder (ADHD), negatively impacting academic and social functioning.
- Standard treatments include behavioral therapy and optimizing ADHD medication, with pharmacotherapy considered as an adjunct.
- Sleep-onset insomnia (SOI) is a specific sleep disorder prevalent in this population.
Purpose of the Study:
- To evaluate the efficacy and safety of melatonin for treating insomnia in pediatric patients diagnosed with ADHD.
- To synthesize current evidence on melatonin's role as an adjuvant therapy for sleep disturbances in children with ADHD.
Main Methods:
- A comprehensive literature search was conducted across MEDLINE, EMBASE, and Scopus databases up to August 2009.
- Included studies comprised randomized trials, safety studies, meta-analyses, and review articles focusing on melatonin, ADHD, and pediatric insomnia.
- Data from identified English-language human studies were summarized to assess treatment outcomes and adverse events.
Main Results:
- Four studies involving children aged 6-14 with ADHD and insomnia demonstrated improvements in sleep onset and latency with melatonin (3-6 mg doses).
- Melatonin was found to regulate circadian rhythm sleep disorders, specifically sleep-onset insomnia.
- Reported adverse events were transient and mild, indicating good tolerability.
Conclusions:
- Melatonin appears to be a well-tolerated and effective treatment for chronic sleep-onset insomnia in pediatric patients with ADHD.
- Further large-scale, well-designed clinical trials are necessary to establish optimal dosing and confirm long-term safety.
- The use of regulated melatonin products is recommended for consistent efficacy and safety.
Objective:
To evaluate the efficacy and safety of melatonin for the treatment of insomnia in pediatric patients with attention-deficit/hyperactivity disorder (ADHD).
Data Sources:
Literature was accessed through MEDLINE (1948-August 2009), EMBASE (1950-August 2009), and Scopus (1960-August 2009) using the terms melatonin, attention-deficit/hyperactivity disorder (ADHD), pediatric, insomnia, sleep disorder, and sleep. In addition, reference citations from publications identified were reviewed for relevant information.
Study Selection And Data Extraction:
All English-language articles and human studies were identified and evaluated. Results from all identified randomized trials (n = 5), safety studies (n = 1), long-term follow-up studies (n = 1), post hoc retrospective analyses (n = 1), meta-analyses (n = 2), review articles (n = 9), and letters (n = 1) were summarized.
Data Synthesis:
Pediatric insomnia is prevalent in children with ADHD and impacts academic performance, social functioning, overall health, and family life. First-line therapy includes ruling out differential diagnoses, optimizing ADHD stimulant treatment, and initiating good sleep hygiene and behavioral therapy. Adjuvant pharmacotherapy is then an option and melatonin is often prescribed. Melatonin regulates circadian rhythm sleep disorders such as sleep-onset insomnia (SOI) in children with ADHD. Four studies in children with ADHD and insomnia showed improvement in sleep onset and sleep latency. Studies included children 6-14 years old and melatonin doses ranged from 3 to 6 mg administered within a few hours of a scheduled bedtime. In all studies, adverse events were transient and mild. The available melatonin studies are limited by small size and short duration; variable SOI criteria, ADHD criteria, and treatment assessments; and lack of generalizability.
Conclusions:
Available data suggest that melatonin is a well-tolerated and efficacious treatment option for pediatric patients with chronic SOI and ADHD. Regulated melatonin products and larger, well-designed trials to establish optimal dosing regimens and long-term safety are needed.
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