Causality assessment · Expected pharmacological effect

Eszopiclone and Amnesia: is the FAERS signal real?

n=270 co-reports · PRR 3.4 · ROR 3.5

Eszopiclone side-effect profile All assessments See in the full list

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Expected pharmacological effect

Eszopiclone ↔ Amnesia

n=270 co-reports · PRR 3.4 · ROR 3.5

Eszopiclone is a non-benzodiazepine hypnotic with the same GABA-A mechanism as zolpidem; amnesia and complex sleep behaviours are labelled effects (270 co-reports here, PRR 3.4), and it uniquely leaves a metallic taste. Next-day impairment and parasomnias led to the same class warnings and dose reductions as for other Z-drugs.

Regulatory basis: eszopiclone (Lunesta) prescribing information — amnesia; boxed warning for complex sleep behaviours; FDA 2014 dose reduction.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Amnesia occurs after dosing
Strength	met	PRR 3.4, modest
Consistency	met	Reproduced in case series
Specificity	partial	Shared with other Z-drugs
Biological gradient	met	Dose-related
Plausibility	met	GABA-A potentiation and sedation
Coherence	met	Fits the pharmacology
Experiment	met	Trials recorded memory effects
Analogy	met	Analogous to zolpidem amnesia

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✓ Trial evidence found — Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia (NCT00645944)

Adverse event	Eszopiclone Group (n=19) · Placebo Group (n=17)
Memory Problems	1/19	1/17

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →