Hetlioz and Tinnitus - a phase IV clinical study of FDA data


Tinnitus is found among people who take Hetlioz, especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months.

The phase IV clinical study analyzes which people take Hetlioz and have Tinnitus. It is created by eHealthMe based on reports of 5,837 people who have side effects when taking Hetlioz from the FDA, and is updated regularly. You can use the study as a second opinion to make health care decisions.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Feb, 07, 2023

5,837 people reported to have side effects when taking Hetlioz.
Among them, 24 people (0.41%) have Tinnitus.

What is Hetlioz?

Hetlioz has active ingredients of tasimelteon. eHealthMe is studying from 5,837 Hetlioz users for its effectiveness, alternative drugs and more.

What is Tinnitus?

Tinnitus (a ringing in the ears) is found to be associated with 3,245 drugs and 2,781 conditions by eHealthMe.

Number of Hetlioz and Tinnitus reports submitted per year:

Could Hetlioz cause Tinnitus?

Time on Hetlioz when people have Tinnitus *:

  • < 1 month: 25 %
  • 1 - 6 months: 50 %
  • 6 - 12 months: 25 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Tinnitus when taking Hetlioz *:

  • female: 62.5 %
  • male: 37.5 %

Age of people who have Tinnitus when taking Hetlioz *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 7.14 %
  • 40-49: 7.14 %
  • 50-59: 28.57 %
  • 60+: 57.14 %

Common drugs people take besides Hetlioz *:

  1. Zantac: 4 people, 16.67%
  2. Valium: 4 people, 16.67%
  3. Zyrtec: 2 people, 8.33%
  4. Zyprexa: 2 people, 8.33%
  5. Ambien: 2 people, 8.33%
  6. Armour Thyroid: 2 people, 8.33%
  7. Biotin: 2 people, 8.33%
  8. Cymbalta: 2 people, 8.33%
  9. Lunesta: 2 people, 8.33%
  10. Melatonin: 2 people, 8.33%

Common side effects people have besides Tinnitus *:

  1. Insomnia (sleeplessness): 9 people, 37.50%
  2. Drug Ineffective: 8 people, 33.33%
  3. Drowsiness: 6 people, 25.00%
  4. Stress And Anxiety: 5 people, 20.83%
  5. Middle Insomnia (difficulty returning to sleep after awakening either in the middle of the night): 4 people, 16.67%
  6. Weakness: 4 people, 16.67%
  7. Hypotension (abnormally low blood pressure): 3 people, 12.50%
  8. Nightmares (unpleasant dreams): 3 people, 12.50%
  9. Heart Palpitations (feelings or sensations that your heart is pounding or racing): 3 people, 12.50%
  10. Coordination Abnormal (abnormal movement): 2 people, 8.33%

Common conditions people have *:

  1. Circadian Rhythm Sleep Disorder (family of sleep disorders affecting, among other things, the timing of sleep): 8 people, 33.33%
  2. Blindness: 3 people, 12.50%
  3. Pain: 2 people, 8.33%
  4. Major Depression (a mood state that goes well beyond temporarily feeling sad or blue. it is a serious medical illness that affects one's thoughts, feelings): 2 people, 8.33%
  5. Diabetes: 2 people, 8.33%
  6. Eye Disorder: 1 person, 4.17%
  7. Asthma: 1 person, 4.17%

* Approximation only. Some reports may have incomplete information.

Do you take Hetlioz and have Tinnitus?

Check whether Tinnitus is associated with a drug or a condition

How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

Related studies

How severe was Tinnitus and when was it recovered:

Expand to all the drugs that have ingredients of tasimelteon:

Alternative drugs to, pros and cons of Hetlioz:

Common Hetlioz side effects:

Browse all side effects of Hetlioz:

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

Tinnitus treatments and more:

COVID vaccines that are related to Tinnitus:

Common drugs associated with Tinnitus:

All the drugs that are associated with Tinnitus:

Common conditions associated with Tinnitus:

All the conditions that are associated with Tinnitus:

How the study uses the data?

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

Who is eHealthMe?

With medical big data and proven AI 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 600+ 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: 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.

Recent studies on eHealthMe: