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Aricept

Donepezil

An oral daily medication used to treat dementia associated with Alzheimer's disease.

Generic name
Donepezil
Brand name
Aricept
Route
Oral
Marketed by
Eisai
First FDA approval
25 Nov 1996

Where Donepezil is approved

All regulators →

Of the three regulators tracked here, the first to approve Donepezil was the US, on 25 Nov 1996. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
25 Nov 1996
Aricept
NDA020690 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
12 Aug 1997
Aricept
Notice of Compliance 3745
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Donepezil

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ENNHS England
£6.1m
2,125,745 items dispensed, Aug 2025 to Jul 2026
-18% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$3.2m
308,890 prescriptions in 2025 · donepezil hydrochloride, Donepezil Hydrochloride, Donepezil
-3% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Donepezil works

All drug targets →
  • Acetylcholinesterase inhibitor Inhibitor
    Target: ACHE acetylcholinesterase (Yt blood group)
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on ACHE
Diseases it has been tested for in clinical trials, by furthest phase
  • AphasiaPhase 3
  • Cognitive impairmentPhase 3
  • DrowsinessPhase 3
  • Lewy body dementiaPhase 3
  • Memory impairmentPhase 3
  • Multiple sclerosis symptom measurementPhase 3
  • Psychotic symptomsPhase 3
  • SedationPhase 3
  • Stroke disorderPhase 3
  • Vascular dementiaPhase 3
29 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL502, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6599, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

NICE appraisals of Donepezil

All NICE appraisals →

NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Donepezil. 2 are current, and 2 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.

AppraisalNICE recommendationPublishedStatus
Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease
NICE TA217
Recommended Optimised23 Mar 2011
Updated 20 Jun 2018
Current
Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease
NICE TA111
Optimised Only in research22 Nov 2006Current

NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

Patient leaflets for Donepezil

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Donepezil

ATC code
N06DA02
ChEMBL
CHEMBL502
DrugBank
DB00843
PubChem CID
3152
CAS number
120014-06-4
FDA UNII
8SSC91326P
Wikidata
Q415081
Wikipedia
Donepezil

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

What Aricept is used for

ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. ARICEPT is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease ( 1 )

How it works

12.1 Mechanism of Action Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer’s disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil alters the course of the underlying dementing process.

Compare Aricept with

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 11 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.