MedDRA preferred term · pauses in breathing during sleep

Sleep apnoea syndrome: adverse event reports recording this term

18,781 reports to FDA record it, 2004–2026; 0.1% of the database.

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.

18,781
reports recording the term: 0.1% of all reports; 710
reports, 12 months to June 2026: 795 in the 12 months before; 83.9%
marked serious by the reporter: 57.4% across all reports; 4.6%
record death among outcomes, as reported: 9.1% across all reports

18,781 reports in FDA's adverse event database record the MedDRA term "Sleep apnoea syndrome" (in plain words, pauses in breathing during sleep): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

710 reports recorded it in the 12 months to June 2026, down 11% from 795 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 83.9% are marked serious, 4.6% include death among the outcomes and 33.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Xyrem, Prednisone and Humira. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

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

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Xyrem	Central nervous system depressant	2,563	4.2%
Prednisone	Corticosteroid	874	0.5%
Humira	—	771	0.1%
Vioxx	—	636	1.6%
Tiotropium bromide	Anticholinergic	481	0.6%
Gabapentin	Anti-epileptic agent	451	0.6%
Albuterol	beta2-Adrenergic agonist	446	2.5%
Fosamax	Bisphosphonate	366	1.1%
Symbicort	Corticosteroid	354	0.9%
Clonazepam	Benzodiazepine	353	0.9%
Apixaban	Factor Xa inhibitor	342	0.7%
Montelukast sodium	Leukotriene receptor antagonist	329	4.9%
Enbrel	Tumor necrosis factor blocker	322	0.1%
Trazodone	—	317	1.8%
Perindopril	—	303	3.7%
Albuterol sulfate	beta2-Adrenergic agonist	295	0.7%
Nasonex	Corticosteroid	294	5.5%
Oxycodone hydrochloride	Opioid agonist	289	0.3%
Bupropion	Aminoketone	288	1.4%
Entresto	Angiotensin 2 receptor blocker	288	0.3%
Ergocalciferol	Provitamin D2 compound	288	2.9%
Breo Ellipta	Corticosteroid	281	1.3%
Metoprolol	beta-Adrenergic blocker	266	1%
Tramadol	—	263	0.6%
Spironolactone	Aldosterone antagonist	259	1.2%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Corticosteroid	2,939	0.4%	0%
Central nervous system depressant	2,741	3.7%	1.6%
Opioid agonist	1,662	0.2%	0.1%
Atypical antipsychotic	1,023	0.1%	0%
Anticholinergic	952	0.6%	0%
beta2-Adrenergic agonist	950	1%	0.1%
Proton pump inhibitor	932	0.2%	0.1%
Nonsteroidal anti-inflammatory drug	927	0.2%	0%
Benzodiazepine	702	0.3%	0.2%
Bisphosphonate	696	0.7%	0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.5%93

2 to 111.9%358

12 to 170.8%146

18 to 4412%2,262

45 to 6427.9%5,234

65 to 7410.2%1,922

75 and over5.4%1,006

Age not given41.3%7,760

Patient sex

Female50.4%9,474

Male43.2%8,119

Not given6.3%1,188

Grey bar: all 20,646,523 reports in the database. 69.1% of these reports give the United States as the country.

Questions about "Sleep apnoea syndrome"

What does "Sleep apnoea syndrome" mean in an adverse event report?

In plain language: pauses in breathing during sleep. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record sleep apnoea syndrome?

18,781 reports through June 2026 (0.1% of all reports), 710 of them in the latest 12 months.

Which drugs appear most often in these reports?

Xyrem (2,563), Prednisone (874), Humira (771), Vioxx (636) and Tiotropium bromide (481). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.