Donepezil Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Alzheimer's Disease

Mild to moderate Alzheimer's Disease:

Initial dose: 5 mg orally once a day

The dosages of donepezil shown to be effective in controlled clinical trials of the treatment of mild to moderate Alzheimer's disease are 5 mg or 10 mg administered orally once per day. The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. However, there has been some evidence to suggest that a daily oral dose of 10 mg of donepezil might provide additional benefit for some patients. Accordingly, whether or not to use a dose of 10 mg is a matter of prescriber and patient preference.

Moderate to severe Alzheimer's disease:

Donepezil has been shown to be effective in controlled clinical trials at doses of 10 mg and 23 mg administered orally once daily. Results of a controlled clinical trial in moderate to severe Alzheimer's Disease that compared donepezil 23 mg orally once daily to 10 mg orally once daily suggest that a 23 mg dose of donepezil provided additional benefit.

Donepezil should be taken in the evening, just prior to retiring. Donepezil can be taken with or without food. The orally disintegrating tablet should be allowed to dissolve on the tongue followed by a glass of water.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Donepezil is primarily metabolized by the liver. If a decision is made to use donepezil in a patient with liver disease, the drug should be used with caution and the patient should be monitored closely.

Dose Adjustments

Titration: The recommended starting dose of donepezil is 5 mg once daily. Evidence from the trials in mild to moderate Alzheimer's disease indicates that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events compared to the 5 mg dose. In trials using a 6 week titration, the type and frequency of these same adverse events were similar between the 5 mg and 10 mg dose groups. Therefore, because donepezil steady state is achieved about 15 days after it is started and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg once daily can be administered once patients have been on a dose of 10 mg once daily for at least 3 months.

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Donepezil should be taken in the evening, just prior to retiring.

Donepezil can be taken with or without food and should be swallowed whole with water. Donepezil should not be split or crushed.

The 23 mg tablet should not be crushed or chewed because this may increase its rate of absorption.

Donepezil ODT tablets should be allowed to dissolve on the tongue followed by a glass of water.

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