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Dose finding of melatonin for chronic idiopathic childhood sleep onset insomnia: an RCT

Ingeborg M van Geijlswijk1, Kristiaan B van der Heijden, A C G Egberts

  • 1Department of Pharmacy, Faculty of Veterinary Medicine, Utrecht University, Yalelaan 106, 3584 CM, Utrecht, The Netherlands. i.m.vangeijlswijk@uu.nl

Psychopharmacology
|July 30, 2010
PubMed

Insights

Melatonin effectively treats childhood sleep onset insomnia by advancing sleep onset and melatonin release, with timing being more critical than dosage. Doses as low as 0.05 mg/kg are effective when administered correctly.

Area of Science:

  • Pediatric Sleep Medicine
  • Chronobiology
  • Pharmacology

Background:

  • Melatonin pharmacokinetics may differ in children compared to adults.
  • Chronic sleep onset insomnia (CSOI) is prevalent in children.
  • Understanding melatonin's effects in pediatric populations is crucial.

Purpose of the Study:

  • To determine the dose-response relationship of melatonin in advancing dim light melatonin onset (DLMO), sleep onset (SO), and reducing sleep onset latency (SOL).
  • To evaluate melatonin's efficacy in children aged 6-12 years with CSOI.

Main Methods:

  • A randomized, placebo-controlled, double-blind trial involving 72 children with CSOI.
  • Administration of melatonin (0.05, 0.1, 0.15 mg/kg) or placebo for one week.
  • Sleep assessment using logs and actigraphy, measuring shifts in DLMO, SO, and SOL.

Main Results:

  • Melatonin significantly advanced SO and DLMO by approximately 1 hour and reduced SOL by 35 minutes.
  • No significant dose-response relationship was found within the tested dosage range (0.05-0.15 mg/kg).
  • Circadian time of administration (TOA) significantly correlated with treatment effects on DLMO and SO.

Conclusions:

  • Melatonin is effective for treating CSOI in children at a dosage of 0.05 mg/kg.
  • Optimal efficacy is achieved when melatonin is administered 1-2 hours before DLMO and desired bedtime.
  • Timing of administration is a key factor influencing melatonin's effectiveness in pediatric sleep regulation.
Abstract

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