Saphris and Sedation - a phase IV clinical study of FDA data

Summary:

Sedation is reported as a side effect among people who take Saphris (asenapine maleate), especially for people who are female, 20-29 old, have been taking the drug for < 1 month also take Zyprexa, and have Schizophrenia.

The phase IV clinical study analyzes which people have Sedation when taking Saphris. It is created by eHealthMe based on reports of 8,449 people who have side effects when taking Saphris from the FDA, and is updated regularly.

What is Saphris?

Saphris has active ingredients of asenapine maleate. It is often used in bipolar i disorder. eHealthMe is studying from 8,688 Saphris users. Check the latest studies of Saphris.

What is Sedation?

Sedation is found to be associated with 1,317 drugs and 1,290 conditions by eHealthMe. Check the latest studies of Sedation.

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, 31, 2026

8,449 people reported to have side effects when taking Saphris.
Among them, 893 people (10.57%) have Sedation.

Among these 893 people:

* Approximation only. Some reports may have incomplete information.

Do you take Saphris and have Sedation?

- Check whether Sedation 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 Saphris:

Saphris (8,688 reports)

Sedation treatments and more:

Sedation (52,223 reports)

How severe was Sedation and when was it recovered:

Sedation in Saphris

Expand to all the drugs that have ingredients of asenapine maleate:

Sedation and drugs with ingredients of asenapine maleate (958 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 Saphris:

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 Sedation:

Sedation (1,317 drugs)

Browse all the conditions that are associated with Sedation:

Sedation (1,290 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on asenapine maleate (the active ingredients of Saphris) and Saphris (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.