Unisom and Death - a phase IV clinical study of FDA data

Summary:

Death is reported as a side effect among people who take Unisom (doxylamine succinate), especially for people who are male, 60+ old, also take Aspirin, and have Multiple myeloma.

The study is created by eHealthMe based on reports of 3,362 people who have side effects when taking Unisom from the FDA, and is updated regularly.

What is Unisom?

Unisom has active ingredients of doxylamine succinate. It is often used in insomnia. eHealthMe is studying from 3,875 Unisom users. Check the latest studies of Unisom.

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 Sep, 03, 2026

3,362 people reported to have side effects when taking Unisom.
Among them, 19 people (0.57%) died.

Among these 19 people:

What is the gender of people who died when taking Unisom? *

female: 31.58 %
male: 68.42 %

What is the age of people who died when taking Unisom? *

What are other drugs people take besides Unisom? *

What are other side effects people have before they died? *

Hallucinations (sensations that appear real but are created by your mind): 2 people, 10.53%
Spinal Fracture (fracture in one of vertebrae): 2 people, 10.53%
Respiratory Acidosis (respiratory failure or ventilatory failure, causes the ph of blood and other bodily fluids to decrease): 2 people, 10.53%
Rashes (redness): 2 people, 10.53%
Fall: 2 people, 10.53%
Fluid Intake Reduced: 1 person, 5.26%
Chronic Kidney Disease: 1 person, 5.26%
Chronic Obstructive Pulmonary Disease (a progressive disease that makes it hard to breathe): 1 person, 5.26%
Confusional State: 1 person, 5.26%
Drug Exposure During Pregnancy: 1 person, 5.26%

What are the existing conditions these people have? *

Multiple Myeloma (cancer of the plasma cells): 3 people, 15.79%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 2 people, 10.53%
Tobacco Withdrawal Symptoms: 1 person, 5.26%
Hand Fracture: 1 person, 5.26%
Agitation (state of anxiety or nervous excitement): 1 person, 5.26%
Back Pain: 1 person, 5.26%
Blood Disorder: 1 person, 5.26%
Cataplexy (loss of muscle tone accompanied by full conscious awareness): 1 person, 5.26%
Delusion (a false belief or opinion): 1 person, 5.26%
Drug Dependence: 1 person, 5.26%

* Approximation only. Some reports may have incomplete information.

Related studies:

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

Unisom (3,875 reports)

Expand to all the drugs that have ingredients of doxylamine succinate:

Death and drugs with ingredients of doxylamine succinate (294 reports)

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 Unisom:

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 Death:

Death (3,106 drugs)

Browse all the conditions that are associated with Death:

Death (3,686 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on doxylamine succinate (the active ingredients of Unisom) and Unisom (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.