Is it safe to administer modafinil (provigil) to an elderly patient with advanced age (88 years old)?

From the Guidelines

It is not safe for an 88-year-old to take modafinil without careful medical supervision, as the risks of adverse effects, particularly cardiovascular effects, outweigh any potential benefits, according to the most recent and highest quality study available 1.

Risks and Considerations

The use of modafinil in elderly patients poses several concerns, including:

• Potential cardiovascular effects, such as increased blood pressure and heart rate, which are particularly concerning in elderly patients who may already have heart conditions
• Interactions with many medications commonly prescribed to older adults
• Age-related changes in liver and kidney function, which can significantly affect how medications are processed in the body, making standard adult dosing potentially dangerous for elderly patients

Alternative Approaches

If an elderly person is experiencing excessive daytime sleepiness, they should consult with their healthcare provider, who can:

• Evaluate the underlying cause of the sleepiness
• Recommend non-pharmacological approaches, such as lifestyle changes or behavioral therapies
• Consider prescribing a lower dose of modafinil than typically used in younger adults, with close monitoring for side effects

Evidence-Based Recommendations

The American Society of Clinical Oncology guideline update 1 recommends against the use of wakefulness agents, such as modafinil, to manage symptoms of cancer-related fatigue in adults with advanced cancer or at the end of life, due to the lack of clarity on potential risk for long-term adverse events and limited effectiveness in improving cancer-related fatigue. Additionally, the European Society of Cardiology working group on cardiovascular pharmacotherapy 1 highlights the importance of careful consideration of age-related changes in pharmacokinetics and pharmacodynamics when prescribing medications to older adults, and recommends adjusting doses and monitoring for adverse effects to minimize the risk of harm.

From the FDA Drug Label

In clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging Therefore, consideration should be given to the use of lower doses and close monitoring in this population [see Dosage and Administration (2.4)and Clinical Pharmacology (12.3)].

The use of modafinil in an 88-year-old patient may require caution due to the potential for reduced elimination of the drug and its metabolites. It is recommended to consider using lower doses and close monitoring in this population 2.

From the Research

Safety of Modafinil in Elderly Patients

The safety of modafinil in an 88-year-old patient is a concern due to the potential for adverse effects and interactions with other medications.

• The pharmacokinetics of modafinil are not affected to a clinically significant extent by volunteer age 3.
• However, both the maximum plasma concentration and the elimination half-life of the drug are increased in patients with hepatic or renal impairment 3.
• A study in healthy volunteers found that single night-time doses of modafinil had no significant effects on objective sleep variables or sleep structure in young or elderly healthy volunteers 3.
• Another study found that short-term administration of modafinil did not elicit a significant response with regard to blood pressure in patients with obstructive sleep apnea 4.

Potential Adverse Effects

• Common adverse effects of modafinil include headache, nausea, and nervousness 3, 5, 6.
• Insomnia and dry mouth have also been reported as adverse effects of modafinil 5, 6.
• The incidence or severity of adverse events associated with the use of modafinil did not appear to be dose-related 3.

Considerations for Elderly Patients

• Elderly patients may be more susceptible to the adverse effects of modafinil due to age-related changes in physiology and the potential for interactions with other medications.
• The recommended dosage of modafinil is 200 or 400 mg/day, given once or twice daily (morning and midday) to patients with narcolepsy 3.
• However, the dosage and administration of modafinil in elderly patients should be individualized and monitored closely to minimize the risk of adverse effects.