Should donepezil be tapered slowly or stopped abruptly when discontinuing?

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Donepezil Discontinuation: Abrupt vs. Tapering

Donepezil can be discontinued abruptly without tapering, as the beneficial effects of donepezil abate over 6 weeks following discontinuation without evidence of a rebound effect. 1

Evidence for Abrupt Discontinuation

The FDA drug label for donepezil specifically addresses discontinuation, stating that:

  • Following 6 weeks of placebo washout, the beneficial effects of donepezil abate without evidence of a rebound effect 1
  • Clinical trials have successfully used abrupt discontinuation protocols with 3-week and 6-week washout periods 1

This is the highest quality evidence available, coming directly from the FDA-approved drug labeling, which is based on the original clinical trials for donepezil.

Potential Concerns with Abrupt Discontinuation

While the FDA label supports abrupt discontinuation, some research suggests caution:

  • A small open-label study in patients with Dementia with Lewy Bodies and Parkinson's Disease with Dementia found that sudden withdrawal of donepezil produced acute cognitive and behavioral decline 2
  • This decline was reversed when donepezil was restarted, suggesting that the deterioration was related to the loss of therapeutic effect rather than a withdrawal syndrome 2

Tapering Approach (If Preferred)

If tapering is preferred due to individual patient factors, the following approach can be considered, based on medication tapering guidelines:

  • Reduce the dose by 5-10% every 1-2 weeks 3
  • For patients on 10mg daily, consider:
    • Reducing to 5mg daily for 2-4 weeks
    • Then discontinuing completely

Monitoring During Discontinuation

Regardless of whether donepezil is discontinued abruptly or tapered:

  • Monitor for cognitive decline, which would represent loss of therapeutic effect rather than withdrawal 1, 2
  • Be prepared to restart the medication if significant cognitive or behavioral deterioration occurs 2
  • Schedule follow-up within 4-6 weeks of discontinuation to assess cognitive status

Clinical Context

The decision to discontinue donepezil should be based on:

  • Lack of therapeutic benefit
  • Intolerable side effects
  • Patient/family preference
  • Advanced disease stage where benefits no longer outweigh risks

Summary

Based on the highest quality evidence (FDA drug labeling), donepezil can be discontinued abruptly without a formal tapering schedule. The beneficial effects will gradually diminish over approximately 6 weeks following discontinuation, without evidence of withdrawal symptoms or rebound effects. If there are specific concerns about individual patient factors, a gradual tapering approach can be considered, but is not required based on the available evidence.

References

Guideline

Medication Tapering Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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