Hydroxyzine and Sleeping difficulty - a phase IV clinical study of FDA data

Summary:

Sleeping difficulty is reported as a side effect among people who take Hydroxyzine (hydroxyzine hydrochloride), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Xolair, and have Pain.

The phase IV clinical study analyzes which people have Sleeping difficulty when taking Hydroxyzine. It is created by eHealthMe based on reports of 51,890 people who have side effects when taking Hydroxyzine from the FDA, and is updated regularly.

What is Hydroxyzine?

Hydroxyzine has active ingredients of hydroxyzine hydrochloride. It is often used in stress and anxiety. eHealthMe is studying from 54,057 Hydroxyzine users. Check the latest studies of Hydroxyzine.

What is Sleeping difficulty?

Sleeping difficulty (difficult sleeping) is found to be associated with 4,231 drugs and 5,349 conditions by eHealthMe. Check the latest studies of Sleeping difficulty.



On Oct, 04, 2025

51,890 people reported to have side effects when taking Hydroxyzine.
Among them, 1,809 people (3.49%) have Sleeping difficulty.

Could Hydroxyzine cause Sleeping difficulty?

Among these 1,809 people:

How long have people been on Hydroxyzine when they have Sleeping difficulty? *

  • < 1 month: 62.96 %
  • 1 - 6 months: 23.46 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 8.64 %
  • 5 - 10 years: 2.47 %
  • 10+ years: 2.47 %

What is the gender of people who have Sleeping difficulty when taking Hydroxyzine? *

  • female: 74.58 %
  • male: 25.42 %

What is the age of people who have Sleeping difficulty when taking Hydroxyzine? *

  • 0-1: 0.0 %
  • 2-9: 3.3 %
  • 10-19: 1.49 %
  • 20-29: 8.16 %
  • 30-39: 9.42 %
  • 40-49: 20.02 %
  • 50-59: 22.68 %
  • 60+: 34.93 %

What are other drugs people take besides Hydroxyzine? *

  1. Xolair: 155 people, 8.57%
  2. Singulair: 150 people, 8.29%
  3. Metformin: 150 people, 8.29%
  4. Furosemide: 136 people, 7.52%
  5. Benadryl: 133 people, 7.35%
  6. Omeprazole: 131 people, 7.24%
  7. Prilosec: 130 people, 7.19%
  8. Prednisone: 129 people, 7.13%
  9. Vitamin D3: 123 people, 6.80%
  10. Clonazepam: 117 people, 6.47%

What are other side effects people have besides Sleeping difficulty? *

  1. Fatigue (feeling of tiredness): 549 people, 30.35%
  2. Nausea (feeling of having an urge to vomit): 502 people, 27.75%
  3. Pain: 488 people, 26.98%
  4. Drug Ineffective: 468 people, 25.87%
  5. Headache (pain in head): 447 people, 24.71%
  6. Rashes (redness): 371 people, 20.51%
  7. Depression: 353 people, 19.51%
  8. Joint Pain: 320 people, 17.69%
  9. High Blood Pressure: 318 people, 17.58%
  10. Weight Increased: 303 people, 16.75%

What are the existing conditions these people have? *

  1. Pain: 210 people, 11.61%
  2. Depression: 180 people, 9.95%
  3. High Blood Pressure: 170 people, 9.40%
  4. Urticaria (rash of round, red welts on the skin that itch intensely): 113 people, 6.25%
  5. Diabetes: 113 people, 6.25%
  6. High Blood Cholesterol: 93 people, 5.14%
  7. Quit Smoking: 77 people, 4.26%
  8. Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 73 people, 4.04%
  9. Sleep Disorder: 70 people, 3.87%
  10. Constipation: 67 people, 3.70%

* Approximation only. Some reports may have incomplete information.

Do you take Hydroxyzine and have Sleeping difficulty?

- Check whether Sleeping difficulty is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously



Related studies:

Effectiveness of, long term effects of, and alternative drugs to Hydroxyzine:

Sleeping difficulty treatments and more:

How severe was Sleeping difficulty and when was it recovered:

Expand to all the drugs that have ingredients of hydroxyzine hydrochloride:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Common Hydroxyzine side effects:

Browse all side effects of Hydroxyzine:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Common drugs associated with Sleeping difficulty:

Browse all the drugs that are associated with Sleeping difficulty:

Common conditions associated with Sleeping difficulty:

Browse all the conditions that are associated with Sleeping difficulty:

Drugs similar to Hydroxyzine and Sleeping difficulty :

Related publications that referenced our studies


How the study uses the data?

The study uses data from the FDA. It is based on hydroxyzine hydrochloride (the active ingredients of Hydroxyzine) and Hydroxyzine (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.



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