Fluoxetine and Sleep terror - a phase IV clinical study of FDA data

Summary:

Sleep terror is reported as a side effect among people who take Fluoxetine (fluoxetine hydrochloride), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Xyrem, and have Narcolepsy.

The phase IV clinical study analyzes which people have Sleep terror when taking Fluoxetine. It is created by eHealthMe based on reports of 94,370 people who have side effects when taking Fluoxetine from the FDA, and is updated regularly.

What is Fluoxetine?

Fluoxetine has active ingredients of fluoxetine hydrochloride. It is often used in depression. eHealthMe is studying from 98,824 Fluoxetine users. Check the latest studies of Fluoxetine.

What is Sleep terror?

Sleep terror (felling of terror in sleep) is found to be associated with 303 drugs and 387 conditions by eHealthMe. Check the latest studies of Sleep terror.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.



On Aug, 18, 2026

94,370 people reported to have side effects when taking Fluoxetine.
Among them, 35 people (0.04%) have Sleep terror.

Could Fluoxetine cause Sleep terror?

Among these 35 people:

How long have people been on Fluoxetine when they have Sleep terror? *

  • < 1 month: 75 %
  • 1 - 6 months: 25 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Sleep terror when taking Fluoxetine? *

  • female: 50 %
  • male: 50 %

What is the age of people who have Sleep terror when taking Fluoxetine? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 4 %
  • 20-29: 16 %
  • 30-39: 24 %
  • 40-49: 0.0 %
  • 50-59: 28 %
  • 60+: 28 %

What are other drugs people take besides Fluoxetine? *

  1. Xyrem: 8 people, 22.86%
  2. Prozac: 4 people, 11.43%
  3. Mirtazapine: 4 people, 11.43%
  4. Abilify: 3 people, 8.57%
  5. Clonazepam: 3 people, 8.57%
  6. Hydrocodone Bitartrate And Acetaminophen: 3 people, 8.57%
  7. Meloxicam: 3 people, 8.57%
  8. Depo-Estradiol: 3 people, 8.57%
  9. Cortisone Acetate: 3 people, 8.57%
  10. Celecoxib: 3 people, 8.57%

What are other side effects people have besides Sleep terror? *

  1. Aggression: 8 people, 22.86%
  2. Hyperhidrosis (abnormally increased sweating): 7 people, 20.00%
  3. Nausea (feeling of having an urge to vomit): 6 people, 17.14%
  4. Nightmares (unpleasant dreams): 6 people, 17.14%
  5. Sleep Walking (walking during sleep): 5 people, 14.29%
  6. Pain In Extremity: 5 people, 14.29%
  7. Weight Increased: 4 people, 11.43%
  8. Appetite - Increased (increased appetite is when you want to eat much more often or in larger quantities than your body requires): 4 people, 11.43%
  9. Drowsiness: 4 people, 11.43%
  10. Fatigue (feeling of tiredness): 4 people, 11.43%

What are the existing conditions these people have? *

  1. Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 8 people, 22.86%
  2. Cataplexy (loss of muscle tone accompanied by full conscious awareness): 6 people, 17.14%
  3. Swelling: 3 people, 8.57%
  4. Back Pain: 3 people, 8.57%
  5. Parkinson's Disease: 2 people, 5.71%
  6. Hypotonia (low muscle tone): 2 people, 5.71%
  7. Drowsiness: 2 people, 5.71%
  8. Depressed Mood: 2 people, 5.71%
  9. Bipolar Disorder (mood disorder): 2 people, 5.71%
  10. Adjustment Disorder: 2 people, 5.71%

* Approximation only. Some reports may have incomplete information.

Do you take Fluoxetine and have Sleep terror?

- Check whether Sleep terror is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
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Related studies:

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

Sleep terror treatments and more:

How severe was Sleep terror and when was it recovered:

Expand to all the drugs that have ingredients of fluoxetine 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+

Browse all side effects of Fluoxetine:

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

Browse all the drugs that are associated with Sleep terror:

Browse all the conditions that are associated with Sleep terror:


How the study uses the data?

The study uses data from the FDA. It is based on fluoxetine hydrochloride (the active ingredients of Fluoxetine) and Fluoxetine (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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