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Melatonin Task Force

Members : Sarah Blunden (Australia),Carlos Bolanos (Colombia), Oliviero Bruni (Italy), Samuele Cortese (United Kingdom), Osman Ipsiroglu (Canada), Lindsay Jeastadt (USA; coordinator), Suresh Kotagal (USA; Chair), Beth Malow (USA), Indra Narang (Canada), Magda L. Nunes (Brazil), Lina Marcela Tavera Saldana (Colombia), Narong Simakajornboon (USA), Barbara Gnidovec Strazisar (Slovenia), and  Guanghai Wang (China)

Interim Report June 9, 2023

In April 2022, IPSA formed a task force to review literature on the role of melatonin in improving sleep in children with autism and neurodevelopmental disorders, and make  evidence-based recommendations for the sleep community.

The task force searched for randomized controlled trials published between 2012 and 2022 in children with autism / neurodevelopmental disorders aged 2 through 18 years. Each study was reviewed by two experts. There were a total of 867 subjects in the pool, with two thirds being male. The dose of melatonin ranged from 2.5 mg to 12 mg. Melatonin formulations used were PedPRM (in 4/7 studies), fast release or immediate release (in 2/7) and controlled release in 1/7. Sleep diaries and sleep questionnaires were utilized in all studies, with actigraphy data being also available in 5/7 studies. Duration of the studies was from 12 to 52 weeks. There was significantly reduced initial sleep latency and increased total sleep time in all studies. The most common side effects were fatigue, somnolence and cough, occurring in 6 to 28 percent of subjects. In the longest duration study of 103 weeks, there was no impact on height, weight, body mass index or the Tanner stages of sexual development.

Some caveats are:

  1. The possibility of observer bias cannot be ruled out.
  2.  It is unclear from some of the studies as to which aspect of sleep was most likely to improve, such as delayed sleep onset, multiple night awakenings, etc.
  3. The analysis was not designed to assess which melatonin preparation was most efficacious, e.g. prolonged release melatonin versus the immediate release formulation
  4. The task force recommends a dose of 2- 10 mg at bedtime, with periodic reassessment of the patient’s progress in 2-4 months
  5. There are no studies on use of melatonin in children below the age of two years. As a precaution, melatonin should not be prescribed in this age group
  6. Practitioners may prescribe melatonin for insomnia in children with autism or neurodevelopmental disorders who are two years of age or older.

The full report is currently a work in progress.

Respectfully submitted,Suresh Kotagal, M.D.
Task Force chair.
June 9, 2023.

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