Reaction profile

The FDA adverse-event record for not sleeping

1,198 FDA reports name not sleeping, a high-volume reaction in the CVM extract (VeDDRA 140). Plate stamps and neighbourhood peers follow.

#339 of 2,481
by report volume (all reactions)
1,198
reports citing this reaction
6.8%
death-coded share
Dog
most-affected species

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Not sleeping has 1,198 reports now versus 1,165 in that prior snapshot: 33 more (2.8%).

Report change
+33
Death-coded reports
+1
Death-coded share
−0.1 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Not sleeping changes

FDA AER · VeDDRA plate

Code 140 VOL-MID

VOL-MID · DEATH-PAR · UPPER-Q · PHOTO-FINISH · SPECIES-DOG · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-MID 1,198 reports
  • DEATH-PAR 6.8%
  • UPPER-Q #339/2481
  • PHOTO-FINISH Hind limb paralysis
  • SPECIES-DOG Dog · 744
  • DRUG-LEAD Buprenorphine · 398
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Hind limb paralysis (±5 reports)

Upper-third report volume drives the scale stamps on this plate; death-coded share and co-report peers follow. Not a clinical diagnosis.

High-volume neighbourhood around Not sleeping

Upper-third volume poles plus nearest peers, not a full reaction corpus board reprint.

Vomiting · highest174348Skin lump · near1212Not sleeping · this reaction1198Hind limb paralysis · near1193Bone and joint disord… · near1189Eosinophilia · near1183Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Not sleeping

Not sleeping: low death-coded share in the FDA AER plate

Signature read: 1,198 reports place Not sleeping in the upper third of FDA AER volume (#339 of 2,481). Report volume is upper-third scale: 1,198 named reports in the openFDA extract. Death-coded share is lower-third: 81 of 1,198 reports (6.8% of named reports). Nearest volume peer: Hind limb paralysis (±5 reports). Lead species Dog (744). Lead co-reported drug Buprenorphine (398).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Buprenorphine appears in filings alongside this reaction; that is association, not causation. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Dog 744
Cat 452
Horse 1
Unknown 1

Breeds Most Affected

Domestic Shorthair 240
Cat (unknown) 74
Retriever - Labrador 60
Crossbred Canine/dog 55
Shih Tzu 37
Chihuahua 32
Maltese 32
Terrier - Yorkshire 30
Retriever - Golden 30
Domestic Longhair 30

Associated Drugs

Buprenorphine 398
Milbemycin Oxime + Spinosad 102
Isoflurane 95
Maropitant Citrate 81
Robenacoxib 80
Dexmedetomidine 65
Gabapentin 60
Propofol 57
Ketamine 56
Afoxolaner 56
Cefovecin Sodium 54
Butorphanol 51
Carprofen 47
Trilostane 44
Pyrantel Pamoate;Sarolaner 43
Ivermectin + Pyrantel As Pamoate Salt 41
Midazolam 41
Bedinvetmab 39
Spinosad 37
Fipronil 9.8%/S-Methoprene 8.8%/Cyphenothrin 5.2% Squeeze-On 37

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Not sleeping, both floored at ≥50 reports so the neighborhoods stay in the advertised mass (the volume chart above is the unfloored photo-finish strip).

Similar report volume

Nearest other reactions by FDA report count (1,198 here).

Similar death-coded share

Nearest other reactions by death-coded share (6.8% here), distinct from the volume row.

What to do with this reaction

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Not sleeping (#339 of 2,481 by report volume); death-coded 6.8%. PlainBreed reaction plate · report volume stamp 1,198 · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →