Pharmacologic class (EPC) · 2 drug pages

Melatonin receptor agonist: adverse event reports filed with FDA

8,851 reports list a drug in this class as a suspect or interacting product, 2005–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

8,851
reports across the class: 0% of all reports; 160
reports, 12 months to June 2026: 363 in the 12 months before; 14.3%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Melatonin receptor agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 8,851 adverse event reports received by FDA, 0% of the database, from October 2005 to May 2026.

160 reports arrived in the 12 months to June 2026, down 56% from 363 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 14.3% of the class's reports are marked serious, 2.8% record death among the outcomes and 6.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (26.7%), insomnia (10.3%) and middle insomnia (8.8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
HetliozTasimelteon	brand	5,638	150	10.2%	Drug ineffective
RozeremRamelteon	brand	3,213	10	21.4%	Drug ineffective

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected26.7%2,359
Insomniadifficulty sleeping10.3%912
Middle insomnia8.8%777
Somnolencedrowsiness7.9%696
Initial insomnia6.6%584
Headachehead pain5.8%516
Product dose omission issuea dose was missed5.2%462
Nightmarenightmares4.4%388
Fatiguetiredness4.2%375
Poor quality sleep4%355
Abnormal dreamsunusual dreams3.8%338
Feeling abnormalfeeling odd or not right3%267
Nauseafeeling sick3%263
Dizzinesslight-headedness or unsteadiness2.9%256
Sleep disordera sleep problem2.2%197
Therapeutic product effect decreased2.2%191
Inappropriate schedule of product administrationthe product was taken at the wrong times2.1%185
Anxietyanxiety2%179
Incorrect product administration duration1.9%165
Malaisegeneral feeling of being unwell1.7%147
Deaththe patient died; cause not stated by this term1.6%143
Product dose omissiona dose was missed1.5%137
Hypersomniasleeping too much1.4%122
Vomitingbeing sick1.3%118
Falla fall1.3%115

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death2.8%250

Life-threatening0.5%47

Hospitalisation (initial or prolonged)6.1%537

Disability0.2%21

Congenital anomaly0%3

Other serious7.2%638

Not serious85.7%7,586

Patient age

Under 20%3

2 to 110.1%10

12 to 170.5%41

18 to 4410.7%943

45 to 6423.1%2,045

65 to 749.4%834

75 and over6.9%613

Age not given49.3%4,362

Who reported

Physician19.4%1,713

Pharmacist5.4%478

Other health professional17.6%1,557

Lawyer0%0

Consumer or non-health professional53.7%4,751

Not given4%352

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Melatonin receptor agonist reports

Which drugs are in the Melatonin receptor agonist class on this site?

Hetlioz and Rozerem. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

8,851 reports through June 2026, 160 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (26.7%), insomnia (10.3%), middle insomnia (8.8%), somnolence (7.9%) and initial insomnia (6.6%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.