Is hydroxyzine (an antihistamine) effective for treating insomnia?

Hydroxyzine for Insomnia Treatment

Hydroxyzine is not recommended as a first-line treatment for insomnia due to limited evidence supporting its efficacy and safety for this indication, and it is not FDA-approved for insomnia treatment. 1

Efficacy and Evidence

Hydroxyzine has mixed efficacy for sleep-related outcomes based on limited evidence:

• A 2023 systematic review identified only 5 studies (207 patients total) evaluating hydroxyzine for sleep, showing mixed results for sleep onset, maintenance, and quality 2
• The FDA label for hydroxyzine does not include insomnia as an approved indication, only mentioning its use as a sedative for premedication and following general anesthesia 1
• The American Academy of Sleep Medicine does not include hydroxyzine in its recommended medications for insomnia treatment 3

Recommended Alternatives for Insomnia

According to the American Academy of Sleep Medicine, better evidence-based options for insomnia include:

• First-line treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I) 3
• For sleep onset insomnia: Zolpidem (10mg adults, 5mg elderly), zaleplon (10mg), or ramelteon (8mg) 3
• For sleep maintenance insomnia: Eszopiclone (2-3mg), doxepin (3-6mg), temazepam (15mg), or suvorexant (10-20mg) 3

Safety Concerns with Hydroxyzine

Several safety concerns exist with hydroxyzine use for insomnia:

• The National Cancer Institute cautions about antihistamine use due to daytime sedation and delirium risk, especially in older patients 4
• A comparative safety study found that sedating antihistamines (including hydroxyzine) had a higher hazard ratio for suicide attempts compared to zolpidem, though not statistically significant (HR = 1.37,95% CI 0.90-2.07) 5
• Common side effects include dry mouth and excessive sedation 2
• Potential drug interactions exist, including a case report of priapism when hydroxyzine was added to risperidone 6

Duration of Treatment Considerations

If hydroxyzine is used despite these concerns:

• Guidelines recommend limiting pharmacological treatment for insomnia to 4-5 weeks when possible 3
• The FDA label notes that hydroxyzine's effectiveness as an antianxiety agent for long-term use (>4 months) has not been assessed by systematic clinical studies 1
• Regular reassessment of the drug's usefulness for the individual patient is necessary 1

Clinical Pitfalls to Avoid

• Avoid long-term use of any sleep medication due to potential for dependence and tolerance 4, 7
• Over-the-counter antihistamines (like hydroxyzine) are not recommended for chronic insomnia due to relative lack of efficacy and safety data 4
• Using the lowest effective dose is crucial to minimize side effects 3
• Elderly patients and those with respiratory conditions require special caution with sedating medications 3

In conclusion, while hydroxyzine may be considered as a short-term option for adults with insomnia when other therapies have failed 2, its use should be limited due to insufficient evidence for efficacy and safety compared to other available treatments that have stronger evidence and FDA approval for insomnia.