Subsys and Insomnia exacerbated - a phase IV clinical study of FDA data

Summary:

Insomnia exacerbated is reported as a side effect among people who take Subsys (fentanyl), especially for people who are female, 40-49 old, have been taking the drug for 6 - 12 months also take Oxycontin, and have Breakthrough pain.

The phase IV clinical study analyzes which people have Insomnia exacerbated when taking Subsys. It is created by eHealthMe based on reports of 9,232 people who have side effects when taking Subsys from the FDA, and is updated regularly.

What is Subsys?

Subsys has active ingredients of fentanyl. eHealthMe is studying from 9,239 Subsys users. Check the latest studies of Subsys.

What is Insomnia exacerbated?

Insomnia exacerbated (severe sleeplessness) is found to be associated with 2,678 drugs and 976 conditions by eHealthMe. Check the latest studies of Insomnia exacerbated.

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, 26, 2026

9,232 people reported to have side effects when taking Subsys.
Among them, 13 people (0.14%) have Insomnia exacerbated.

Could Subsys cause Insomnia exacerbated?

Among these 13 people:

How long have people been on Subsys when they have Insomnia exacerbated? *

What is the gender of people who have Insomnia exacerbated when taking Subsys? *

female: 53.85 %
male: 46.15 %

What is the age of people who have Insomnia exacerbated when taking Subsys? *

What are other drugs people take besides Subsys? *

What are other side effects people have besides Insomnia exacerbated? *

Depression: 6 people, 46.15%
Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 5 people, 38.46%
Pain: 4 people, 30.77%
Weakness: 3 people, 23.08%
Migraine (headache): 3 people, 23.08%
Injection Site Bruising: 2 people, 15.38%
Drug Withdrawal Syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation): 2 people, 15.38%
Nausea And Vomiting: 2 people, 15.38%
Mobility Decreased (ability to move is reduced): 2 people, 15.38%
Weight Increased: 2 people, 15.38%

What are the existing conditions these people have? *

Breakthrough Pain: 6 people, 46.15%
Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 2 people, 15.38%
Peripheral Swelling: 2 people, 15.38%
Pain: 2 people, 15.38%
Eye Swelling: 2 people, 15.38%
Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 1 person, 7.69%
Migraine With Aura (headache with vision weakness): 1 person, 7.69%
Headache (pain in head): 1 person, 7.69%

* Approximation only. Some reports may have incomplete information.

Do you take Subsys and have Insomnia exacerbated?

- Check whether Insomnia exacerbated is associated with a drug or a condition
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Related studies:

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

Subsys (9,239 reports)

Browse all side effects of Subsys:

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 Insomnia exacerbated:

Insomnia exacerbated (2,678 drugs)

Browse all the conditions that are associated with Insomnia exacerbated:

Insomnia exacerbated (976 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on fentanyl (the active ingredients of Subsys) and Subsys (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.