Hydroxyzine for Chronic Insomnia in Adults
Hydroxyzine is not recommended for the treatment of chronic insomnia in adults. The American Academy of Sleep Medicine explicitly advises against over-the-counter antihistamines, including hydroxyzine, due to lack of efficacy data, safety concerns, and problematic side effects such as daytime sedation and delirium risk, particularly in older patients and those with advanced illness 1, 2.
Why Hydroxyzine Should Be Avoided
Guideline Recommendations Against Antihistamines
The American Academy of Sleep Medicine does not recommend antihistaminergic drugs for insomnia treatment based on insufficient evidence of efficacy and concerning safety profile 1, 3.
Over-the-counter antihistamines like hydroxyzine lack robust efficacy data for insomnia and carry significant safety concerns including daytime sedation, anticholinergic effects, and delirium risk, especially in elderly patients 1, 4.
The European Insomnia Guideline (2023) explicitly states that antihistaminergic drugs are not recommended for insomnia treatment 3.
Limited and Mixed Evidence
A systematic review of hydroxyzine for insomnia identified only 5 small studies (207 total patients) with mixed efficacy across sleep onset, sleep maintenance, and sleep quality measures 5.
The evidence base is insufficient to support hydroxyzine as a reliable treatment option, with most studies failing to report comprehensive safety outcomes 5.
Significant Safety Concerns from FDA Labeling
The FDA label for hydroxyzine highlights multiple serious risks 6:
QT prolongation and Torsade de Pointes have been reported, requiring caution in patients with cardiac risk factors, recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias 6.
Potentiation of CNS depression when used with other sedatives, narcotics, or barbiturates, requiring dose reduction of concomitant medications 6.
Acute Generalized Exanthematous Pustulosis (AGEP), a serious skin reaction that requires immediate discontinuation 6.
Increased sedation and confusion in elderly patients, who should be started on low doses and observed closely due to greater frequency of decreased hepatic, renal, or cardiac function 6.
Patients must be warned against driving or operating machinery due to drowsiness, and advised against simultaneous use of alcohol or other CNS depressants 6.
Recommended Treatment Algorithm Instead
First-Line: Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I should be the initial treatment for all adults with chronic insomnia before any pharmacological intervention, with superior long-term efficacy and minimal adverse effects compared to medications 1, 2.
CBT-I includes stimulus control therapy, sleep restriction therapy, relaxation techniques, and cognitive restructuring, deliverable through individual therapy, group sessions, telephone-based programs, or web-based modules 1, 2.
Second-Line: FDA-Approved Pharmacotherapy
If CBT-I is insufficient or unavailable, the American Academy of Sleep Medicine recommends 1:
For sleep onset insomnia:
For sleep maintenance insomnia:
- Low-dose doxepin 3-6 mg (particularly appropriate for elderly patients with favorable safety profile) 1, 4
- Eszopiclone 2-3 mg 1
- Suvorexant (orexin receptor antagonist) 1
For combined sleep onset and maintenance:
Third-Line: Sedating Antidepressants
Consider sedating antidepressants for patients with comorbid depression or anxiety after first-line agents have failed 1.
Low-dose doxepin (3-6 mg) is specifically recommended with strong evidence for sleep maintenance 1, 4.
Critical Pitfalls to Avoid
Do not use hydroxyzine or other antihistamines as they lack efficacy data and carry unacceptable safety risks including anticholinergic effects, daytime sedation, and delirium 1, 4, 3.
Do not skip CBT-I in favor of immediate pharmacotherapy, as behavioral interventions provide more sustained long-term benefits 1, 2.
Do not use long-acting benzodiazepines (like diazepam) due to increased risks without clear benefit, particularly in elderly patients 1, 4.
Do not combine multiple sedative medications as this significantly increases fall risk, cognitive impairment, and complex sleep behaviors 1.
Special Consideration: Short-Term Use Only
If hydroxyzine were to be considered despite guideline recommendations, it should only be for very short-term use (up to 4 weeks maximum) in patients for whom previous therapy was ineffective, not tolerated, or contraindicated 5.
However, given the availability of safer and more effective FDA-approved alternatives with better evidence, there is no compelling reason to choose hydroxyzine over guideline-recommended options 1, 3.