At what age can melatonin (melatonin) be considered for pediatric sleep disorders?

Melatonin Use in Children: Age Considerations and Guidelines

Melatonin can be considered for use in children as young as 2 years of age, particularly for those with neurodevelopmental disorders and sleep problems, though it should only be used after behavioral interventions have failed. 1

Age-Based Recommendations

Children Under 2 Years

• Not recommended due to limited safety data in this age group
• No established guidelines support use in this population

Children 2-6 Years

• Can be considered for children with:
  • Neurodevelopmental disabilities 2, 1
  • Autism spectrum disorders 2
  • Delayed sleep-wake phase disorder (DSWPD) 2
• Starting dose: 0.15 mg/kg taken 1.5-2 hours before habitual bedtime 1
• For children with psychiatric comorbidities: 3 mg if <40 kg 2

Children 6-12 Years

• Appropriate for:
  • Primary sleep disorders 3
  • DSWPD with or without psychiatric comorbidities 2
  • Sleep problems associated with neurodevelopmental conditions 2, 1
• Dosing: 3-5 mg based on weight (3 mg if <40 kg; 5 mg if >40 kg) 2

Adolescents (12+ Years)

• Similar indications as younger children
• Dosing: 3-5 mg, typically taken 30-60 minutes before desired bedtime 2, 1

Treatment Algorithm

1. First step: Non-pharmacological interventions

   • Implement sleep hygiene practices
   • Behavioral interventions should be tried first in all cases 4
   • Document these attempts before initiating melatonin 5

2. When to consider melatonin:

   • After failure of behavioral interventions (documented in only 68% of cases) 5
   • For specific conditions:
     • Autism spectrum disorders
     • ADHD
     • Other neurodevelopmental disorders
     • DSWPD

3. Dosing protocol:

   • Start with lowest effective dose
   • For sleep onset issues: immediate-release formulation 1
   • For sleep maintenance: sustained/prolonged-release 1
   • Timing: 30-60 minutes before desired bedtime for most conditions 1
   • For DSWPD: 1.5-2 hours before habitual bedtime 1

4. Monitoring and follow-up:

   • Assess efficacy at 2-4 weeks 4
   • Monitor for side effects (documented in only 43-46% of cases) 5
   • Schedule periodic treatment breaks to assess continued need 1, 6
   • Stop treatment at least once yearly (preferably during summer) 6

Safety Considerations

• Melatonin ingestions in children increased 530% from 2012-2021, becoming the most frequently ingested substance among children reported to poison control centers 7
• Most common adverse effects: morning drowsiness, headache, dizziness 1, 6
• Potential concerns with long-term use:
  • Effects on growth hormone regulation
  • Possible impacts on reproductive development 1
  • Limited long-term safety data beyond 6 months 6

Clinical Pearls

• Look for USP verification on melatonin products to ensure dose accuracy 1
• Higher doses (≥10 mg) increase risk of adverse effects 1
• Regular monitoring for efficacy and side effects is essential but often neglected in clinical practice 5
• Melatonin has shown efficacy in reducing sleep latency by 14.88 minutes and increasing total sleep time by 18.97 minutes in children with various conditions 4

Melatonin appears safe and effective for children as young as 2 years with specific sleep disorders, particularly those with neurodevelopmental conditions, but should be used judiciously with appropriate monitoring and periodic reassessment of continued need.