Cenobamate is a novel once-daily oral antiepileptic drug. Correct dosage and administration, strict adherence to precautions, and a healthy lifestyle are critical to ensuring its efficacy and safety.

I. Dosage and Administration of Cenobamate

1. Pre-Treatment Assessment

(1) Prior to initiation, if liver function tests have not been performed within the last 3 months, serum transaminases (ALT and AST) and total bilirubin must be measured to establish a baseline.

(2) Dose adjustment is required in patients with concomitant hepatic impairment.

2. Recommended Initiation and Titration Schedule

This product is administered orally once daily, with or without food. Rapid dose escalation is strictly prohibited. The specific regimen is as follows:

(1) Weeks 1–2: 12.5 mg once daily (starting dose).

(2) Weeks 3–4: 25 mg once daily.

(3) Weeks 5–6: 50 mg once daily.

(4) Weeks 7–8: 100 mg once daily.

(5) Weeks 9–10: 150 mg once daily.

(6) Week 11 and beyond: 200 mg once daily (maintenance dose).

(7) If clinically necessary and well-tolerated, the dose may be further increased from 200 mg, by 50 mg increments every two weeks, to a maximum of 400 mg once daily.

3. Dose Adjustment in Patients with Hepatic Impairment

(1) Mild to moderate hepatic impairment (Child-Pugh Class A or B): Maximum recommended dose is 200 mg once daily; further dose reduction may be considered.

(2) Severe hepatic impairment (Child-Pugh Class C): Use is not recommended.

4. Administration Instructions

(1) Tablets may be swallowed whole or crushed.

(2) Crushed tablets should be mixed with 25 mL of water and administered immediately orally (as a suspension) or via nasogastric tube.

(3) The crushed tablet-water mixture must not be stored and should be used immediately.

5. Discontinuation

Unless rapid discontinuation is required due to severe adverse reactions, the dose should be gradually tapered over at least 2 weeks to reduce the risk of increased seizure frequency or status epilepticus.

II. Precautions for Cenobamate Use

1. Strict Adherence to Titration Rate

(1) Rapid dose escalation (weekly or faster) can cause DRESS syndrome, with fatal cases reported.

(2) The dose must be increased strictly every two weeks; do not accelerate the titration rate.

2. Liver Function Monitoring

(1) Seek immediate medical attention for liver function tests if unexplained nausea, vomiting, right upper abdominal pain, fatigue, anorexia, jaundice, or dark urine develops during treatment.

(2) Treatment should be interrupted or discontinued if transaminases exceed 3 times the upper limit of normal (ULN) and total bilirubin exceeds 2 times the ULN.

3. Vigilance for DRESS Syndrome

(1) DRESS presents with fever, rash, lymphadenopathy, facial swelling, and may be associated with hepatitis, nephritis, myocarditis, etc.

(2) Be alert for fever or lymphadenopathy even in the absence of rash. Discontinue immediately if DRESS is suspected.

4. Avoid Driving and Operating Machinery

(1) This product may cause somnolence, dizziness, fatigue, blurred vision, and balance disturbances.

(2) Do not drive or operate hazardous machinery until you know how the medication affects you.

5. Avoid Alcohol and Other CNS Depressants

Alcohol and other central nervous system (CNS) depressants (e.g., sedatives, hypnotics) may exacerbate somnolence and sedation; concomitant use should be avoided during treatment.

6. Cardiac Effects

(1) This product may shorten the QT interval. Seek prompt medical attention for persistent palpitations or syncope.

(2) Use caution when co-administering other drugs that shorten the QT interval (e.g., certain antiarrhythmics).

7. Suicide Risk Monitoring

(1) Antiepileptic drugs may increase the overall risk of suicidal ideation and behavior.

(2) Patients and caregivers should watch for sudden mood changes, worsening depression, anxiety, agitation, aggressive behavior, or suicidal thoughts. Contact a physician immediately if any abnormalities occur.

8. Reduced Efficacy of Oral Contraceptives

Women of childbearing potential using oral contraceptives must use additional non-hormonal contraceptive methods (e.g., condoms, intrauterine devices).

III. Healthy Lifestyle for Patients Taking Cenobamate

1. Consistent Medication Adherence

(1) Take the medication at the same time each day to avoid missed doses.

(2) If a dose is missed and the next scheduled dose is more than 12 hours away, take the missed dose immediately. If it is nearly time for the next dose, skip the missed dose. Do not double the dose.

2. Adequate Rest and Avoidance of Fatigue

(1) Fatigue lowers the seizure threshold and may exacerbate drug-related somnolence and asthenia.

(2) Maintain a regular sleep schedule; avoid staying up late and overexertion.

3. Abstinence from Alcohol

(1) Alcohol not only intensifies CNS depression but may also trigger seizures.

(2) Complete abstinence from alcohol is strongly recommended during treatment.

4. Safety Precautions

(1) Due to the high risk of dizziness and balance disturbances, the home environment should be modified to reduce fall risks (e.g., keep floors dry, install handrails).

(2) Use a shower chair when bathing and avoid climbing alone.

5. Regular Follow-Ups

(1) Undergo regular monitoring of liver function, serum potassium, ECG, and neurological status as directed by your physician.

(2) Do not reduce or discontinue the dose without medical advice.