Pharmacologic class (EPC) · 3 drug pages

Orexin receptor antagonist: adverse event reports filed with FDA

12,711 reports list a drug in this class as a suspect or interacting product, 2014–2026.

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.

12,711
reports across the class: 0.1% of all reports; 692
reports, 12 months to June 2026: 565 in the 12 months before; 22%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Orexin receptor antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 12,711 adverse event reports received by FDA, 0.1% of the database, from November 2014 to June 2026.

692 reports arrived in the 12 months to June 2026, up 22% from 565 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 22% of the class's reports are marked serious, 2.1% record death among the outcomes and 7.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (27.9%), nightmare (8.4%) and somnolence (6.9%). 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
BelsomraSuvorexant	brand	9,391	178	17.9%	Drug ineffective
QuviviqDaridorexant	brand	2,315	381	26.3%	Drug ineffective
DayvigoLemborexant	brand	1,005	133	50.2%	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 expected27.9%3,549
Nightmarenightmares8.4%1,072
Somnolencedrowsiness6.9%883
Insomniadifficulty sleeping6.5%821
Abnormal dreamsunusual dreams5.9%753
Headachehead pain4.8%610
Feeling abnormalfeeling odd or not right4.4%565
Hallucinationseeing or hearing things that are not there3.4%437
Fatiguetiredness3.2%401
No adverse eventno adverse event was reported3.1%397
Sleep paralysis3%375
Dizzinesslight-headedness or unsteadiness2.6%332
Anxietyanxiety2.4%303
Wrong technique in product usage processthe product was used in the wrong way2.3%298
Nauseafeeling sick2.2%284
Poor quality sleep2%252
Middle insomnia1.9%236
Suicidal ideationthoughts of suicide1.8%224
Product dose omission issuea dose was missed1.7%212
Adverse eventan unwanted medical event, type not specified1.6%198
Sleep disordera sleep problem1.5%197
Product use issuea problem in how the product was used1.5%188
Malaisegeneral feeling of being unwell1.5%186
Product availability issuethe product was not available1.4%183
Overdosea dose above the recommended amount1.4%177

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death2.1%265

Life-threatening1.4%178

Hospitalisation (initial or prolonged)7.4%943

Disability1.2%147

Congenital anomaly0.1%8

Other serious16.3%2,076

Not serious78%9,916

Patient age

Under 20.1%15

2 to 110%2

12 to 170.2%28

18 to 448.1%1,028

45 to 6414.7%1,873

65 to 7410.4%1,328

75 and over11.6%1,470

Age not given54.8%6,967

Who reported

Physician18.6%2,362

Pharmacist4.3%549

Other health professional6.9%876

Lawyer0%4

Consumer or non-health professional69.4%8,818

Not given0.8%102

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 Orexin receptor antagonist reports

Which drugs are in the Orexin receptor antagonist class on this site?

Belsomra, Quviviq and Dayvigo. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

12,711 reports through June 2026, 692 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 (27.9%), nightmare (8.4%), somnolence (6.9%), insomnia (6.5%) and abnormal dreams (5.9%).

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.