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

Summary:

Initial insomnia is reported as a side effect among people who take Aleve pm (diphenhydramine hydrochloride; naproxen sodium), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Aleve, and have Pain.

The phase IV clinical study analyzes which people have Initial insomnia when taking Aleve pm. It is created by eHealthMe based on reports of 2,081 people who have side effects when taking Aleve pm from the FDA, and is updated regularly.

What is Aleve pm?

Aleve pm has active ingredients of diphenhydramine hydrochloride; naproxen sodium. eHealthMe is studying from 2,094 Aleve pm users. Check the latest studies of Aleve pm.

What is Initial insomnia?

Initial insomnia (feeling of inadequate or poor-quality sleep) is found to be associated with 710 drugs and 690 conditions by eHealthMe. Check the latest studies of Initial insomnia.

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

2,081 people reported to have side effects when taking Aleve pm.
Among them, 20 people (0.96%) have Initial insomnia.

Among these 20 people:

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

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

female: 88.89 %
male: 11.11 %

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

What are other drugs people take besides Aleve pm? *

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

Drug Ineffective: 5 people, 25.00%
Middle Insomnia (difficulty returning to sleep after awakening either in the middle of the night): 3 people, 15.00%
Stress And Anxiety: 2 people, 10.00%
Nausea (feeling of having an urge to vomit): 2 people, 10.00%
Insomnia (sleeplessness): 2 people, 10.00%
Abdominal Discomfort: 2 people, 10.00%
Nightmares (unpleasant dreams): 1 person, 5.00%
Nervousness: 1 person, 5.00%
Indigestion: 1 person, 5.00%
Confusion: 1 person, 5.00%

What are the existing conditions these people have? *

Sleep Disorder: 5 people, 25.00%
Pain: 5 people, 25.00%
Joint Pain: 2 people, 10.00%
Pain In Jaw: 1 person, 5.00%
Muscle Aches (muscle pain): 1 person, 5.00%
Back Pain: 1 person, 5.00%
Abnormal Sleep-Related Event: 1 person, 5.00%

* Approximation only. Some reports may have incomplete information.

Do you take Aleve pm 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 Aleve pm:

Aleve pm (2,094 reports)

Initial insomnia treatments and more:

Initial insomnia (12,139 reports)

How severe was Initial insomnia and when was it recovered:

Initial insomnia in Aleve pm

Expand to all the drugs that have ingredients of diphenhydramine hydrochloride; naproxen sodium:

Initial insomnia and drugs with ingredients of diphenhydramine hydrochloride; naproxen sodium (20 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 Aleve pm:

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 Initial insomnia:

Initial insomnia (710 drugs)

Browse all the conditions that are associated with Initial insomnia:

Initial insomnia (690 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on diphenhydramine hydrochloride; naproxen sodium (the active ingredients of Aleve pm) and Aleve pm (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.