What over-the-counter (OTC) sleep aid options are available for pediatric populations?

Over-the-Counter Sleep Options for Children

Melatonin is the only over-the-counter option with strong evidence for pediatric sleep problems, starting at 1 mg given 30-60 minutes before bedtime for children over 2 years old. 1, 2

First-Line Approach: Behavioral Interventions Before Medication

Before considering any OTC medication, behavioral strategies should be implemented as they have robust evidence and avoid medication side effects 2:

• Establish consistent bedtime routines with fixed sleep and wake times, which reduces insomnia with an effect size of 0.67 2, 3
• Implement a bedtime routine including bath, massage, and quiet activities, which can improve sleep within just 3 nights 4
• Remove all screens from the bedroom and eliminate screen use before bed, as bedroom screen devices significantly worsen sleep problems and behavioral difficulties 5
• Create a sleep-promoting environment: quiet, darkened, warm bedroom with consistent wake times and daytime exercise 6, 7

Melatonin: The Evidence-Based OTC Option

Melatonin has the strongest evidence base and is the safest pharmacological choice for pediatric insomnia 1, 2:

Dosing Strategy

• Start with 1 mg administered 30-60 minutes before bedtime in children over 2 years 1, 2
• Titrate by 1 mg every 2 weeks if ineffective, up to maximum doses of:
  • 1 mg in infants
  • 2.5-3 mg in older children
  • 5-6 mg in adolescents 1, 3

Expected Benefits

• Reduces sleep onset latency by 16-60 minutes with an effect size of 1.7 2, 3
• Improves sleep duration, number of night wakings, and bedtime resistance 1
• Generally well-tolerated with mild side effects 2, 3

Timing Considerations

• For advancing bedtime: 0.5 mg given 3-4 hours before desired bedtime 1
• For sedating effect: Higher doses (as above) given 30 minutes before bed 1

Antihistamines: Limited Evidence and Significant Concerns

Antihistamines like diphenhydramine are commonly used but have minimal evidence supporting their effectiveness 1:

• Only 26% of children show improvement in global sleep assessments with sedating antihistamines 1
• Children develop tolerance to sedating properties while antimuscarinic and anticholinergic side effects persist 1
• More recent studies show no reduction in nighttime awakenings with diphenhydramine in healthy children 1
• Not recommended as first-line therapy due to limited efficacy and side effect profile 1

What to Avoid

Do NOT use these OTC or prescription options in children 1, 2:

• Benzodiazepines: Risk of respiratory depression, ataxia, excessive sedation, memory impairment, paradoxical disinhibition, and addiction 1, 2
• Chloral hydrate: Discontinued in the US due to hepatotoxicity and respiratory depression risk 1
• Second-generation antipsychotics (like quetiapine): Significant metabolic syndrome risk, should not be prescribed for sleep alone 1

Follow-Up and When to Escalate

Schedule follow-up within 2-4 weeks after starting any intervention 2, 3:

• Expect improvement within 4 weeks for most interventions 2, 3
• Monitor for daytime sleepiness which can impair school performance and requires dose adjustment 2, 3
• Reassess if no benefit within 4 weeks and consider alternative approaches or referral 2

Refer to Sleep Specialist If:

• Insomnia not improving with behavioral interventions plus melatonin 2
• Severe insomnia causing significant daytime impairment or safety concerns 2
• Suspected underlying sleep disorders (sleep apnea, restless legs syndrome) 2
• Child already taking multiple sleep medications 2

Critical Pitfalls to Avoid

• Never start with medication when behavioral interventions have strong evidence and avoid side effects 2
• Don't implement behavioral strategies without adequate parent education and hands-on support, as this leads to failure 2
• Avoid using antihistamines as first-line despite their OTC availability, given limited efficacy 1
• Never use benzodiazepines for chronic pediatric insomnia due to serious risks 2