Is it safe to prescribe hydroxyzine (an antihistamine) for sleep to a 3-year-old child?

Hydroxyzine for Sleep in a 3-Year-Old: Not Recommended

Hydroxyzine should not be prescribed for sleep in a 3-year-old child; melatonin is the safer, evidence-based first-line pharmacological option after behavioral interventions have been attempted. 1, 2, 3

Why Hydroxyzine Is Problematic in Young Children

Limited Evidence and Safety Concerns

• Antihistamines like hydroxyzine are among the most widely prescribed sedatives in pediatric practice, yet the evidence supporting their use for sleep remains limited, particularly in very young children. 2

• A concerning population-based study found that repeat prescriptions of hydroxyzine in children under 5 years were associated with significantly increased rates of neurodevelopmental disorders by age 10, including tics (OR 1.55), anxiety (OR 1.34), and conduct disturbances (OR 1.34), with non-significant trends toward ADHD and emotional disturbances. 4

• The study specifically recommended "the shortest possible duration for hydroxyzine use in preschool-age children" due to these long-term neurodevelopmental concerns. 4

Serious Adverse Effects

• Hydroxyzine can cause significant sedative effects that impair cognitive function and performance, with drivers being 1.5 times more likely to be involved in fatal accidents when taking first-generation antihistamines. 5

• A case report documented supraventricular tachycardia in a 9-year-old child on clinical doses of hydroxyzine, with recurrent palpitations and chest tightness over 5 months that resolved after discontinuation. 6

• Recent forensic data shows hydroxyzine is increasingly identified in impaired driving investigations, with behavioral observations including incoordination, slurred speech, and difficulty following instructions—effects that would be particularly concerning in a developing 3-year-old. 7

Recommended Approach for Pediatric Sleep Problems

First-Line: Behavioral Interventions

• Good sleep practices and behavioral interventions are the first recommended treatments for pediatric insomnia, supported by moderate-to-low level evidence, though they can be challenging to implement. 2

• A thorough sleep history should include sleep diaries, actigraphy, and assessment of precipitating factors such as behavioral concerns, anxiety, or environmental issues. 1

Second-Line: Melatonin

• Melatonin is supported by an increasing body of evidence as the safest pharmacological choice for children with sleep disturbances, including those with neurodevelopmental disabilities. 2, 3

• Pediatric psychiatrists identified melatonin as the most popular first-choice treatment for sleep disturbances in pediatric populations. 1

• Extended-release melatonin formulations can be considered for sleep maintenance issues. 1

When Hydroxyzine Might Be Mentioned (But Still Not Ideal)

• Hydroxyzine appears in guidelines only as a treatment option for insomnia in children with neurodevelopmental disorders like Prader-Willi syndrome, where it is listed alongside melatonin and other antihistamines—not as a preferred agent. 1

• Even in nuclear medicine procedural guidelines for anxiolysis in children, hydroxyzine is noted as "approved for anxiolytic use" but is mentioned alongside the caveat that benzodiazepines are "most often not recommended in children under 16 years" and that nitrous oxide is preferable. 1

Critical Age Consideration

• At 3 years old, this child falls into the preschool age group where the neurodevelopmental concerns from the longitudinal study are most relevant. 4

• Nitrous oxide for anxiolysis has a reported failure rate of 20-30% and is less effective in children under 3 years, suggesting this age group requires particularly careful medication selection. 1

Clinical Algorithm for This Patient

1. Assess and optimize sleep hygiene (consistent bedtime routine, appropriate sleep environment, limiting screen time)
2. Implement behavioral interventions (bedtime fading, positive reinforcement, graduated extinction if appropriate)
3. If pharmacological intervention is necessary, trial melatonin (starting at 0.5-1 mg, 30-60 minutes before bedtime, titrating as needed)
4. Reserve hydroxyzine only for specific indications (pruritus from dermatological conditions, acute anxiety in controlled settings—not chronic sleep management)
5. If sleep problems persist despite melatonin, refer to pediatric sleep medicine specialist to evaluate for underlying sleep pathology before escalating to other medications 1

Important Caveats

• The lack of FDA or European Medicines Agency approval for any sleep medication in children means all pharmacological options are off-label, making safety profiles and evidence quality paramount in decision-making. 2, 3

• Benzodiazepines should only be used for transient insomnia and are not recommended for chronic use in children. 1, 2

• If hydroxyzine were to be used despite these concerns, it should be at the lowest effective dose for the shortest possible duration, with close monitoring for behavioral changes, cardiac symptoms, and excessive sedation. 4, 6, 5