Reaction profile

The FDA adverse-event record for difficulty sleeping

Name: Difficulty sleeping - FDA Animal Adverse Reaction
Creator: PlainBreed
License: https://open.fda.gov/license/

12 FDA reports name difficulty sleeping, a lower-volume reaction in the CVM extract (VeDDRA 1412). Plate stamps and neighbourhood peers follow.

#2380 of 2,481
by report volume (all reactions): 12
reports citing this reaction: 0.0%
death-coded share: Human
most-affected species

Compiled by PlainBreed

Verify with FDA CVM →

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. Difficulty sleeping has 12 reports now versus 12 in that prior snapshot: 0 the same number of (0.0%).

Report change: +0
Death-coded reports: +0
Death-coded share: +0.0 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 Difficulty sleeping changes

FDA AER · VeDDRA plate

Code 1412 VOL-TRACE

VOL-TRACE · DEATH-RARE · BOTTOM-DECILE · PHOTO-FINISH · SPECIES-HUMAN · DRUG-LEAD · DESK-NARROW · BOOK-FULL

VOL-TRACE 12 reports
DEATH-RARE 0.0%
BOTTOM-DECILE #2380/2481
PHOTO-FINISH Agitated state of mind
SPECIES-HUMAN Human · 12
DRUG-LEAD Afoxolaner · 2
DESK-NARROW 1 breeds
BOOK-FULL 8/8 fields

Nearest volume peer: Agitated state of mind (±0 reports)

Instrument codes from this reaction’s FDA CVM adverse-event extract: volume band, death-coded share, corpus rank, photo-finish peer, lead species, lead drug, breed desk, and book completeness. Not a clinical diagnosis.

Lower-volume neighbourhood around Difficulty sleeping

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

FDA AER report volume · neighbourhood around Difficulty sleeping

Difficulty sleeping: low death-coded share in the FDA AER plate

Signature read: 12 reports place Difficulty sleeping in the lower third of FDA AER volume (#2380 of 2,481). Report volume is lower-third scale: 12 named reports in the openFDA extract. Death-coded share is lower-third: 0 of 12 reports (0.0% of named reports). Nearest volume peer: Agitated state of mind (±0 reports). Lead species Human (12). Lead co-reported drug Afoxolaner (2).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Afoxolaner 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

Human 12

Breeds Most Affected

Unknown 12

Associated Drugs

Afoxolaner 2

Fluralaner 13.64% 12-Week Chew 2

Spinosad 1

Antacid (Unknown) 1

Imidacloprid + Moxidectin 1

Unknown Thyroid Supplement 1

Vitamins 1

Prednisone 1

Shampoo 1

Estrogen 1

Selamectin 1

Enrofloxacin 1

Ivermectin(1.55%)/Praziquantel(7.75%) Paste 1

Ivermectin 0.5% Pour-On 1

Fluralaner Spot-On Solution 1

Rabacfosadine 1

Buprenorphine 1

Unknown Medication 1

Tilmicosin 1

Lisinopril 1

What to do with this reaction

Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
Browse the full reaction directory to compare report counts across reaction types. All reactions

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 Difficulty sleeping (#2380 of 2,481 by report volume); death-coded 0.0%. PlainBreed reaction plate · report volume stamp 12 · 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 →