Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 9/7/2025

Hydroxyzine for Insomnia Treatment

Efficacy and Safety Concerns

  • The American Academy of Sleep Medicine recommends against the use of hydroxyzine as a first-line treatment for insomnia due to its limited efficacy data, potential for daytime sedation, and risk of adverse effects, particularly in older adults 1, 2
  • Hydroxyzine and other over-the-counter antihistamines are not recommended for the treatment of chronic insomnia due to lack of demonstrated efficacy and safety concerns 1, 3
  • The National Cancer Institute warns about the cautious use of antihistamines for sleep due to risks of daytime sedation and delirium, especially in older patients 2, 3

Adverse Effects

  • First-generation antihistamines like hydroxyzine are associated with significant sedative effects including drowsiness and performance impairment, even without subjective awareness of these effects 4
  • Hydroxyzine can cause anticholinergic effects including dry mouth and eyes, constipation, urinary retention, and increased risk for narrow-angle glaucoma 4
  • Older adults are particularly susceptible to psychomotor impairment from first-generation antihistamines, with increased risk of falls and subdural hematomas 4
  • The American Academy of Sleep Medicine recommends Cognitive Behavioral Therapy for Insomnia (CBT-I) as the first-line treatment for chronic insomnia before considering pharmacological options 5, 6
  • When pharmacotherapy is necessary, benzodiazepine receptor agonists (such as zolpidem) or ramelteon are recommended as first-line agents 5, 7
  • Sedating antidepressants such as trazodone, mirtazapine, and doxepin are preferred non-scheduled options over antihistamines, especially when comorbid depression/anxiety exists 6

Clinical Approach to Insomnia

  • The American Academy of Sleep Medicine recommends beginning with CBT-I as the foundation of treatment, and if pharmacotherapy is needed, using short/intermediate-acting benzodiazepine receptor agonists (zolpidem, eszopiclone) or ramelteon as first-line agents 5, 6
  • Sedating antidepressants (doxepin, mirtazapine, trazodone) are recommended as second-line agents 6, 8

Important Considerations

  • The American Academy of Sleep Medicine explicitly does not recommend over-the-counter antihistamine sleeping aids due to lack of efficacy and safety data 5
  • If medication is prescribed for insomnia, it should be at the lowest effective dose for the shortest period possible 3
  • Regular follow-up is essential to assess efficacy, monitor for side effects, and evaluate the ongoing need for medication 5, 8

Special Populations

  • In older adults, hydroxyzine and other first-generation antihistamines should be used with extreme caution due to increased sensitivity to adverse effects 4, 9

REFERENCES

5

clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an american academy of sleep medicine clinical practice guideline. [LINK]

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2017

6

Non-Scheduled Drugs for Managing Insomnia [LINK]

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

7

Tratamento da Insônia com Zolpidem [LINK]

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

8

Management of Insomnia in Patients with Hypertension and Kidney Disease [LINK]

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

9

clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an american academy of sleep medicine clinical practice guideline. [LINK]

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2017