What is the recommended dosage of melatonin (melatonin) for pediatric patients?

Melatonin Dosing in Pediatric Patients

For typically developing children with sleep onset insomnia, start with weight-based dosing of 0.15 mg/kg (approximately 1.6-4.4 mg) administered 1.5-2 hours before bedtime for children without psychiatric comorbidities, or use 3 mg if <40 kg and 5 mg if >40 kg for children with psychiatric comorbidities. 1, 2

Age-Specific Dosing Algorithm

Children ≥6 Years Without Comorbidities

• Initial dose: 0.15 mg/kg taken 1.5-2 hours before habitual bedtime 1, 2
• This typically translates to approximately 1.6-4.4 mg depending on weight 1
• Effectiveness can be assessed after as little as 6 nights of treatment 2, 3
• The American Academy of Sleep Medicine considers this approach to have moderate-level evidence for Delayed Sleep-Wake Phase Disorder 1

Children ≥6 Years With Psychiatric Comorbidities

• Weight-based approach: 3 mg if <40 kg OR 5 mg if ≥40 kg 1, 2
• Administer at 18:00-19:00 (earlier than non-comorbid children) 2, 3
• Continue for 4 weeks to evaluate effectiveness 2
• Fast-release formulation is recommended over prolonged-release 1, 2

Children 2-6 Years

• Low-dose melatonin administered 30-60 minutes before bedtime is appropriate 4
• European expert guidance supports use in children over 2 years old when behavioral interventions have failed 4
• Most Italian pediatricians prescribe 1 mg/day in this age group 5

Children <2 Years

• Limited evidence exists for this age group 6
• Use should be highly individualized and reserved for cases where behavioral interventions have been exhausted 4

Dosing Considerations and Titration

Starting low is critical: Lower doses may actually be more effective than higher doses due to receptor desensitization that occurs with doses ≥10 mg 1, 2. The American Academy of Sleep Medicine notes that higher doses can disrupt normal circadian signaling mechanisms 1.

If initial dose is ineffective after 1-2 weeks:

• Increase by 3 mg increments 1
• Maximum dose typically should not exceed 12-15 mg 2
• Reassess timing of administration before increasing dose 1

Timing of Administration

• For sleep onset insomnia: 30-60 minutes before bedtime 4
• For circadian rhythm disorders: 1.5-2 hours before habitual bedtime 1, 2
• For children with psychiatric comorbidities: Earlier administration (18:00-19:00) may be more effective 2, 3

Treatment Duration

• Initial trial: 6 nights to 4 weeks depending on comorbidities 2
• Short-term use: 1 month is most common in clinical practice 5
• Extended use: If needed beyond several months, periodic attempts to reduce frequency and dose are indicated 1
• Consider tapering to every other or every third night rather than daily use for long-term management 1

Safety Profile in Pediatrics

Melatonin is generally safe in children when dosed appropriately: No serious adverse reactions have been documented across pediatric age groups 1, 2, 3. The most common side effects are:

• Morning sleepiness (1.66%) 3
• Headache (0.74%) 3
• Gastrointestinal upset (more common at higher doses) 1, 2

Pubertal development concerns have not been substantiated: A study of children using melatonin (mean dose ~3 mg) for approximately 3 years showed no significant differences in Tanner stages compared to non-users 1.

Critical Caveats and Contraindications

Use with extreme caution in:

• Patients taking warfarin (potential drug interaction) 1, 2, 3
• Patients with epilepsy (case reports of potential interactions) 1, 2, 3

Product quality concerns: Melatonin is regulated as a dietary supplement in the US, raising concerns about purity and reliability of stated doses 1, 2. Choose United States Pharmacopeial Convention Verified formulations when possible for more reliable dosing 1, 2.

Behavioral interventions must come first: Melatonin should only be used after sleep hygiene measures and behavioral therapies have been attempted 4. The American Academy of Sleep Medicine emphasizes that melatonin should be part of a comprehensive approach, not a single intervention 3.

Special Populations

Children with Autism Spectrum Disorders

• Melatonin has shown effectiveness for improving sleep duration, latency, and reducing night wakings 1
• Use the same weight-based dosing as for children with psychiatric comorbidities (3-5 mg based on weight) 1, 2

Children in ICU Settings

• Mean dose used is 3 mg 7
• Typically started within 48 hours of PICU admission 7
• May reduce burden of positive delirium scores, particularly with ≥7 days of therapy 7

Formulation Selection

Immediate-release is preferred over prolonged-release for sleep onset problems, as slow-release formulations appear less effective for sleep onset 2. Prolonged-release melatonin (2 mg) has shown benefit primarily in elderly patients, not in pediatric populations 2.