What are the safe and effective pharmacologic and non‑pharmacologic options for children who have difficulty falling or staying asleep?

Managing Sleep Problems in Children

First-Line Approach: Behavioral Interventions

Begin with behavioral interventions as the primary treatment for all children with sleep difficulties, as these have strong evidence (effect size 0.67) and avoid medication side effects. 1, 2, 3

Core Behavioral Strategies

• Establish consistent bedtime routines with fixed sleep and wake times, which reduces insomnia with an effect size of 0.67. 1, 2, 3
• Implement visual schedules to help children understand bedtime expectations and reduce anxiety about the sleep process, particularly effective for children who prefer routine. 1, 3
• Use bedtime fading by temporarily moving bedtime later to match the child's natural sleep onset, then gradually shift earlier in 15-30 minute increments. 1, 3
• Provide hands-on parent education about sleep hygiene, proper sleep-onset associations, and consistent limit-setting—this is crucial for success. 1, 3
• Maintain sleep diaries to objectively track sleep onset, duration, and night wakings. 1, 3
• Counsel families to avoid co-sleeping, as parental presence is a predictor of nighttime awakenings even in healthy children. 4, 2

Environmental Modifications

• Ensure a quiet, darkened, and warm bedroom with consistent wake times and daytime exercise. 5
• For children with atopic dermatitis, consider wet wrap therapy (wet gauze or cotton pajamas) to maintain skin hydration and provide a physical barrier against scratching. 4

Pharmacological Interventions: When Behavioral Approaches Are Insufficient

Melatonin: The Evidence-Based Choice

Melatonin is the only pharmacological option with strong evidence and the safest profile for pediatric insomnia. 1, 2, 3

Dosing Strategy

• Start with 1 mg given 30-60 minutes before bedtime for children over 2 years old. 1, 2, 3
• Titrate by 1 mg every 2 weeks if ineffective, up to age-appropriate maximum doses: 1 mg in infants, 2.5-3 mg in older children, and 5 mg in adolescents. 4, 2
• For phase advancement (advancing bedtime earlier), use 0.5 mg given 3-4 hours before bedtime. 4, 2

Expected Efficacy

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

Antihistamines: Not Recommended

• Sedating antihistamines improve global sleep in only 26% of children with limited data supporting their use. 4, 2
• Children develop tolerance to sedating properties while anticholinergic side effects persist (dry mouth, constipation, urinary retention). 4, 2
• Should not be used as first-line therapy due to limited efficacy and unfavorable side effect profile. 2

Medications to Avoid

• Benzodiazepines: Risk of respiratory depression, ataxia, excessive sedation, memory impairment, paradoxical disinhibition, and addiction. 2, 3
• Chloral hydrate: Discontinued in the US due to hepatotoxicity and respiratory depression risk. 2
• Second-generation antipsychotics: Should not be prescribed for sleep alone due to significant metabolic syndrome risk. 2

Critical Pre-Treatment Assessment

Medical Screening

• Screen for comorbid sleep-disordered breathing (pediatric obstructive sleep apnea), asthma, or allergic rhinitis before initiating any sleep intervention. 4, 2
• Evaluate for gastrointestinal disorders and epilepsy as underlying contributors. 1
• Assess for restless leg syndrome/periodic limb movement disease in children with persistent sleep disturbances. 4

Psychiatric and Medication Review

• Screen for psychiatric comorbidities, particularly anxiety disorders and ADHD, as they directly contribute to sleep difficulties. 1
• Review current medications to identify potential exacerbators of insomnia symptoms. 1

Important Caveat

• Do not rely solely on caregiver reports in young children, as they are unable to accurately keep sleep logs and caregiver estimates are variable in quality. 2

Follow-Up and Monitoring

• Schedule follow-up within 2-4 weeks after initiating any intervention. 1, 2, 3
• Expect improvement within 4 weeks for most interventions. 2, 3
• Monitor for treatment-emergent daytime sleepiness, which can impair school performance and requires dose adjustment. 1, 3
• Reassess diagnosis and consider alternative approaches if no benefit is seen within 4 weeks. 3

When to Refer to a Sleep Specialist

• Insomnia not improving with initial behavioral interventions and melatonin trial. 1, 3
• Particularly severe insomnia causing significant daytime impairment or placing the child at risk while awake at night. 1, 3
• Suspected underlying primary sleep disorders such as sleep apnea or restless legs syndrome. 1, 3
• Children taking multiple medications for sleep when initially assessed. 3

Common Pitfalls to Avoid

• Starting with medication when behavioral interventions have strong evidence and avoid medication side effects. 3
• Implementing behavioral strategies without adequate parent education and support, which leads to failure. 3
• Using benzodiazepines for chronic insomnia due to risk of disinhibition and behavioral side effects. 3
• Treating behavioral issues without identifying underlying sleep disorders, as aggression, impulsivity, and inattention may be secondary to sleep disturbance. 4