Melatonin and Initial insomnia - a phase IV clinical study of FDA data

Summary:

Initial insomnia is reported as a side effect among people who take Melatonin (melatonin), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Vitamin D3, and have Narcolepsy.

The phase IV clinical study analyzes which people have Initial insomnia when taking Melatonin. It is created by eHealthMe based on reports of 53,570 people who have side effects when taking Melatonin from the FDA, and is updated regularly.

What is Melatonin?

Melatonin has active ingredients of melatonin. It is often used in insomnia. eHealthMe is studying from 56,198 Melatonin users. Check the latest studies of Melatonin.

What is Initial insomnia?

Initial insomnia (feeling of inadequate or poor-quality sleep) is found to be associated with 813 drugs and 675 conditions by eHealthMe. Check the latest studies of Initial insomnia.

On Oct, 24, 2025

53,570 people reported to have side effects when taking Melatonin.
Among them, 143 people (0.27%) have Initial insomnia.

Among these 143 people:

How long have people been on Melatonin when they have Initial insomnia? *

What is the gender of people who have Initial insomnia when taking Melatonin? *

female: 55.22 %
male: 44.78 %

What is the age of people who have Initial insomnia when taking Melatonin? *

What are other drugs people take besides Melatonin? *

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

Fatigue (feeling of tiredness): 24 people, 16.78%
Stress And Anxiety: 22 people, 15.38%
Drug Ineffective: 20 people, 13.99%
Nausea (feeling of having an urge to vomit): 18 people, 12.59%
Drowsiness: 18 people, 12.59%
Headache (pain in head): 16 people, 11.19%
Middle Insomnia (difficulty returning to sleep after awakening either in the middle of the night): 14 people, 9.79%
Fall: 14 people, 9.79%
Pain: 14 people, 9.79%
Diarrhea: 13 people, 9.09%

What are the existing conditions these people have? *

Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 20 people, 13.99%
Cataplexy (loss of muscle tone accompanied by full conscious awareness): 13 people, 9.09%
Pain: 10 people, 6.99%
Stress And Anxiety: 9 people, 6.29%
Attention Deficit Hyperactivity Disorder (a chronic condition including attention difficulty, hyperactivity, and impulsiveness): 9 people, 6.29%
Parkinson's Disease: 7 people, 4.90%
Muscle Spasms (muscle contraction): 6 people, 4.20%
Primary Progressive Multiple Sclerosis (primary progressive inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 6 people, 4.20%
Fibromyalgia (a long-term condition which causes pain all over the body): 5 people, 3.50%
Dermatitis Atopic (inflammatory, chronically relapsing, non-contagious and pruritic skin disorder): 5 people, 3.50%

* Approximation only. Some reports may have incomplete information.

Do you take Melatonin and have Initial insomnia?

- Check whether Initial 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 Melatonin:

Melatonin (56,198 reports)

Initial insomnia treatments and more:

Initial insomnia (12,139 reports)

Common Melatonin side effects:

Browse all side effects of Melatonin:

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

Common drugs associated with Initial insomnia:

Browse all the drugs that are associated with Initial insomnia:

Initial insomnia (813 drugs)

Common conditions associated with Initial insomnia:

Browse all the conditions that are associated with Initial insomnia:

Initial insomnia (675 conditions)

Drugs similar to Melatonin and Initial insomnia :

How the study uses the data?

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