What is the recommended dose of hydroxyzine (an antihistamine) for insomnia?

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Hydroxyzine for Insomnia: Dosage Recommendations

Hydroxyzine is not recommended for the treatment of insomnia based on current clinical practice guidelines, with a recommended dose of 25-50 mg at bedtime when used off-label for short-term sleep issues.

Guideline Recommendations for Insomnia Treatment

  • The American Academy of Sleep Medicine explicitly does not recommend antihistamines like diphenhydramine for sleep onset and sleep maintenance insomnia in adults 1
  • While hydroxyzine is not specifically mentioned in these guidelines, as a first-generation antihistamine it falls into the same category as diphenhydramine, which is explicitly not recommended 1
  • The guidelines instead recommend FDA-approved medications such as:
    • Benzodiazepine receptor agonists (eszopiclone, zaleplon, zolpidem) 1
    • Orexin receptor antagonists (suvorexant) 1
    • Low-dose doxepin for sleep maintenance insomnia 1

Hydroxyzine Dosing When Used Off-Label

  • According to the FDA label, hydroxyzine is approved for anxiety but not specifically for insomnia 2
  • When used off-label for sedation, the FDA label indicates:
    • Adults: 50 to 100 mg as a sedative 2
    • Children: 0.6 mg/kg of body weight 2
  • Recent systematic review evidence suggests doses of 25-50 mg at bedtime have been studied for insomnia, though with mixed efficacy 3

Safety Considerations

  • Common side effects include:

    • Dry mouth (most common reported adverse effect) 3
    • Daytime drowsiness that may persist into the next day 4, 5
    • Potential for impaired reaction times and psychomotor performance 4
  • Important safety concerns:

    • Hydroxyzine causes significant objective sedation and slower reaction times for at least four hours after administration 4
    • Patients may not be aware of their impairment, making this particularly dangerous 4
    • Evening dosing may mitigate some daytime impairment but does not eliminate subjective symptoms 5
    • Potential drug interactions exist, including a case report of priapism when combined with risperidone 6

Clinical Approach to Insomnia Treatment

  • First-line pharmacologic options should include:

    • Zolpidem 10 mg for sleep onset and maintenance insomnia 1, 7
    • Eszopiclone 2-3 mg for sleep onset and maintenance insomnia 1
    • Zaleplon 10 mg for sleep onset insomnia 1
    • Ramelteon 8 mg for sleep onset insomnia 1
    • Low-dose doxepin (3-6 mg) for sleep maintenance insomnia 1
  • If hydroxyzine is used despite these recommendations:

    • Start with 25 mg at bedtime 3
    • May increase to 50 mg if needed and tolerated 3
    • Use for shortest duration possible 3
    • Monitor for next-day impairment 4, 5

Important Caveats

  • Hydroxyzine should be considered only when first-line agents have failed, are contraindicated, or not tolerated 3
  • Patients should be warned about potential next-day impairment even if they don't subjectively feel impaired 4
  • Evening dosing strategy (single bedtime dose rather than divided doses) may help reduce but not eliminate daytime impairment 5
  • Long-term efficacy and safety data for hydroxyzine in insomnia are lacking 3

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Tratamento da Insônia com Zolpidem

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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