Cenobamate is used for partial-onset seizures in adults. Dosing in special populations should be adjusted based on hepatic and renal function, age, and physiological status to ensure safety.

I. Use in Pregnancy and Lactation

1. Pregnancy

There are no adequate human pregnancy data; animal studies suggest embryotoxicity and developmental risks.

Based on animal data, it may cause fetal harm.

Pregnant women are encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry to monitor pregnancy outcomes.

2. Lactation

It is unknown whether cenobamate is excreted in human milk.

The benefits of breastfeeding should be weighed against the mother's clinical need for the drug and potential effects on the breastfed infant.

3. Reproductive Potential and Contraception

It may reduce the effectiveness of oral hormonal contraceptives.

Women of reproductive potential should use additional or alternative non-hormonal contraceptive measures.

II. Use in Pediatric and Geriatric Patients

1. Pediatric Patients

Safety and effectiveness have not been established.

Juvenile animal studies showed that administration caused mortality, delayed sexual maturation, neurobehavioral impairment, decreased sperm count, and reduced brain weight, with no no-effect dose identified.

2. Geriatric Patients

Clinical studies did not include sufficient numbers of patients aged 65 years and older to determine safety and effectiveness.

Geriatric patients should be treated cautiously, usually starting at the low end of the dosing range, with attention to hepatic, renal, and cardiac function and concomitant medications.

III. Use in Patients with Hepatic or Renal Impairment

1. Hepatic Impairment

Use with caution in patients with mild to moderate impairment; the maximum recommended dosage is 200 mg once daily, and further dosage reduction may be considered.

Use is not recommended in patients with severe hepatic impairment.

2. Renal Impairment

Use with caution in patients with mild to moderate and severe impairment; dosage reduction may be considered.

Use is not recommended in patients with end-stage renal disease undergoing dialysis.

3. Dosing Principles

Individualized dosing and close monitoring for adverse reactions are required in special populations.

The drug should be gradually withdrawn to avoid increased seizure frequency.