Hydroxyzine for Sleep: Age Range and Clinical Guidance
Hydroxyzine can be used for short-term insomnia treatment in adults (≥18 years) at doses of 25–100 mg at bedtime, but it is explicitly not recommended as a first-line agent due to limited efficacy data, anticholinergic side effects, and lack of long-term safety evidence. 1, 2
Age-Specific Dosing and Indications
Adults (≥18 years)
- Hydroxyzine 25–50 mg at bedtime is the typical starting dose for short-term insomnia in adults when first-line treatments have failed or are contraindicated; doses up to 100 mg have been studied but carry higher anticholinergic burden. 2
- The medication is approved for anxiolytic use in both Europe and the United States and has few contraindications in the general adult population, though it should be reserved for cases where standard hypnotics are inappropriate. 1
Pediatric Use (Children and Adolescents)
- Hydroxyzine is used in pediatric populations primarily for anxiolysis and sedation during medical procedures (e.g., nuclear medicine imaging), not for chronic insomnia treatment. 1
- In children, hydroxyzine is administered as a sedative antihistamine for procedural anxiety, but specific dosing for sleep disorders in pediatric patients is not established in guidelines, and its use should be limited to acute, situational anxiety rather than ongoing sleep management. 1
Older Adults (≥65 years)
- Hydroxyzine should be avoided in older adults due to strong anticholinergic effects that cause confusion, urinary retention, constipation, falls, daytime sedation, and delirium—risks that are unacceptable in this population. 3
- The 2019 Beers Criteria issue a strong recommendation against antihistamines (including hydroxyzine) in elderly patients because anticholinergic toxicity outweighs any modest sleep benefit. 3
Efficacy and Evidence Quality
- A systematic review of five randomized controlled trials (n=207 adults) found mixed efficacy for hydroxyzine in improving sleep onset, sleep maintenance, and sleep quality, with the most common adverse effect being dry mouth. 2
- The overall quality of evidence is low to moderate, and hydroxyzine should be considered only as a short-term option when previous therapies (e.g., cognitive-behavioral therapy for insomnia [CBT-I], FDA-approved hypnotics) have been ineffective, not tolerated, or contraindicated. 2
- Hydroxyzine is not included in major insomnia treatment guidelines (American Academy of Sleep Medicine, American College of Physicians) as a recommended agent, reflecting the lack of robust long-term data. 3, 4
Safety Precautions and Monitoring
Anticholinergic Toxicity
- Monitor for dry mouth, constipation, urinary retention, confusion, and cognitive impairment, especially in older adults and those on other anticholinergic medications. 3
- Combining hydroxyzine with other anticholinergants (e.g., tricyclic antidepressants, bladder antimuscarinics) compounds toxicity risk and should be avoided. 3
Cardiac Safety
- Hydroxyzine prolongs the QTc interval and should not be combined with other QT-prolonging drugs (e.g., trazodone, certain antipsychotics, macrolide antibiotics) due to additive arrhythmia risk, including torsades de pointes. 1
- Obtain a baseline ECG and monitor QTc if hydroxyzine is used in patients with cardiac risk factors (age >65 years, female sex, electrolyte abnormalities, bradycardia, concurrent QT-prolonging medications). 1
Central Nervous System Depression
- Hydroxyzine produces sedation and should not be combined with other CNS depressants (e.g., benzodiazepines, opioids, alcohol) because additive effects markedly increase the risk of respiratory depression, falls, and cognitive impairment. 1
- In pediatric populations, hydroxyzine is used for procedural sedation but requires monitoring by qualified personnel according to hospital protocols. 1
Priapism Risk
- Alpha-adrenergic antagonism by hydroxyzine can precipitate priapism, particularly when combined with antipsychotics (e.g., risperidone) that also block alpha-1 receptors; patients should be counseled to seek emergency care for prolonged erections. 5
Duration of Use and Discontinuation
- Hydroxyzine should be prescribed for short-term use only (typically ≤4 weeks), as long-term efficacy and safety data are lacking. 2, 6
- A Finnish nationwide study found that sleep medicines (including antihistamines) are often prescribed to older adults without appropriate instructions on temporary use, leading to inappropriate long-term dispensing. 6
- Reassess after 1–2 weeks to evaluate efficacy on sleep onset, sleep maintenance, and daytime functioning; if insufficient, switch to a guideline-recommended hypnotic rather than continuing hydroxyzine. 2
First-Line Alternatives (Guideline-Recommended)
Non-Pharmacologic Therapy
- Cognitive-behavioral therapy for insomnia (CBT-I) is the standard of care and must be initiated before or alongside any medication, as it provides superior long-term outcomes with sustained benefits after discontinuation. 3, 4
Pharmacologic First-Line Options
- For sleep-onset insomnia: Ramelteon 8 mg (no abuse potential, no DEA scheduling) or zaleplon 10 mg (5 mg if ≥65 years) for rapid sleep initiation with minimal next-day sedation. 3, 4
- For sleep-maintenance insomnia: Low-dose doxepin 3–6 mg (minimal anticholinergic effects, no abuse potential) or suvorexant 10 mg (orexin-receptor antagonist with lower cognitive impairment risk). 3, 4
- For combined sleep-onset and maintenance: Eszopiclone 2–3 mg (1 mg if ≥65 years) or zolpidem 10 mg (5 mg if ≥65 years), both with moderate-quality evidence for efficacy. 3, 4
Common Pitfalls to Avoid
- Using hydroxyzine as a first-line agent bypasses evidence-based treatments (CBT-I, FDA-approved hypnotics) with superior efficacy and safety profiles. 3, 4
- Prescribing hydroxyzine to older adults exposes them to unacceptable anticholinergic toxicity (confusion, falls, urinary retention) that outweighs any sleep benefit. 3
- Combining hydroxyzine with QT-prolonging drugs (e.g., trazodone, antipsychotics) markedly increases arrhythmia risk and should be avoided. 1
- Failing to implement CBT-I before or alongside hydroxyzine results in less durable benefit and contravenes guideline recommendations. 3, 4
- Continuing hydroxyzine long-term without reassessment leads to tolerance, anticholinergic side effects, and inappropriate chronic use. 2, 6