Addyi and Middle insomnia - a phase IV clinical study of FDA data

Summary:

Middle insomnia is reported as a side effect among people who take Addyi (flibanserin), especially for people who are female, 30-39 old, have been taking the drug for < 1 month also take Vitamin D, and have Libido decreased.

The phase IV clinical study analyzes which people have Middle insomnia when taking Addyi. It is created by eHealthMe based on reports of 1,419 people who have side effects when taking Addyi from the FDA, and is updated regularly.

What is Addyi?

Addyi has active ingredients of flibanserin. eHealthMe is studying from 1,423 Addyi users. Check the latest studies of Addyi.

What is Middle insomnia?

Middle insomnia (difficulty returning to sleep after awakening either in the middle of the night) is found to be associated with 986 drugs and 971 conditions by eHealthMe. Check the latest studies of Middle insomnia.

On Aug, 01, 2026

1,419 people reported to have side effects when taking Addyi.
Among them, 49 people (3.45%) have Middle insomnia.

Among these 49 people:

How long have people been on Addyi when they have Middle insomnia? *

What is the gender of people who have Middle insomnia when taking Addyi? *

female: 100 %
male: 0.0 %

What is the age of people who have Middle insomnia when taking Addyi? *

What are other drugs people take besides Addyi? *

What are other side effects people have besides Middle insomnia? *

Drowsiness: 8 people, 16.33%
Dizziness: 6 people, 12.24%
Fatigue (feeling of tiredness): 6 people, 12.24%
Dry Mouth: 5 people, 10.20%
Feeling Abnormal: 5 people, 10.20%
Insomnia (sleeplessness): 5 people, 10.20%
Hypotension (abnormally low blood pressure): 4 people, 8.16%
Poor Quality Sleep: 4 people, 8.16%
Drug Ineffective: 4 people, 8.16%
Headache (pain in head): 4 people, 8.16%

What are the existing conditions these people have? *

Libido Decreased (loss of interest in sex): 20 people, 40.82%
Loss Of Libido (loss of sexual urge): 4 people, 8.16%
Insomnia (sleeplessness): 3 people, 6.12%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 3 people, 6.12%
Birth Control: 1 person, 2.04%
Depression: 1 person, 2.04%
Headache (pain in head): 1 person, 2.04%
High Blood Cholesterol: 1 person, 2.04%
High Blood Pressure: 1 person, 2.04%
Hypersensitivity: 1 person, 2.04%

* Approximation only. Some reports may have incomplete information.

Do you take Addyi and have Middle insomnia?

- Check whether Middle insomnia 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 Addyi:

Addyi (1,423 reports)

Middle insomnia treatments and more:

Middle insomnia (21,952 reports)

Browse all side effects of Addyi:

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 Middle insomnia:

Middle insomnia (986 drugs)

Browse all the conditions that are associated with Middle insomnia:

Middle insomnia (971 conditions)

How the study uses the data?

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