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Melatonin is Effective in Decreasing Sleep Latency in Children with ADHD on Stimulants


  • In school-age children with ADHD on stimulant medications, is melatonin a safe and effective intervention for decreasing sleep onset latency as compared to sleep hygiene alone?

Clinical Bottom Lines

1. Melatonin has been shown more effective than sleep hygiene alone at decreasing sleep latency.
2. Though not FDA regulated, melatonin has not been associated with any severe adverse effects in any present studies.
3. Melatonin may be effective at decreasing night-to-night variability, but more studies are needed to support this.
4. Melatonin has not been shown to be effective at improving ADHD symptoms independent of the effect it has on the child's sleep.
5. Melatonin has been shown to improve total nighttime sleep. Describe clinical actions to be taken based on the results of your critical appraisal

Summary of Key Evidence

1. Thirty-three children, ages 6-14 years, with ADHD treated with stimulants, were enrolled in a 2-phase, double-blind, randomized crossover study.
2. In the 28 patients who completed the 10-day sleep hygiene phase of the study, there was a statistically signficant decrease in the mean sleep-onset latency (SOL) measured by the parents somnologs (91.7 minutes to 69.3 minutes) and by actigraphs (98.1 minutes to 73 minutes).
3. In the 19 patients who successfully completed the 30-day crossover portion of the study, there was a statistically significant difference between the mean SOL in the children treated with placebo (62.1 minutes) and children treated with melatonin nightly (46.4 minutes).
4. There was no consistent statistically significant differences in the secondary variables such as night-to-night variability, total nighttime sleep, clinician assessement of sleep, and ADHD symptoms.
5. In the 17 children who were enrolled in the 3 month open-label study, there was not a statistically significant decrease in the SOL (though it did decrease from 46.4 minutes to 31 minutes which could be clinically significant). There was improvement in the total sleep time by 23 minutes.

Additional Comments

  • Study limitations included small sample size, relatively short trial, potential drawbacks of crossover study design, and limited ability to form generalizations due to the strict inclusion criteria.
    Study was performed in 6-14 year olds which may have a wide variation in sleep patterns at baseline.
    Large-scale studies are needed to fully evaluate the safety of this medication as it is not FDA regulated.


1. Li Weiss et al. Sleep Hygiene and Melatonin Treatment for Children and Adolescents with ADHD and Initial Insomnia. J Am Acad Child Adolesc Psychiatry 2006; 45: 512-519.
2. Littner et al. Practice Parameters for the Role of Actigraphy in the Study of Sleep and Circadian Rhythms: An Update for 2002. Sleep 2003; 26: 337-41. 3. Altman, Douglas. Practical Statistics for Medical Research. CRC Press, 1991. List references here

CAT Author: Anna Little, MD

CAT Appraisers: James Gurney, MD

Date appraised: 10/29/2008

Last updated June 15, 2009
Department of Pediatrics and Communicable Diseases
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