Critical Dosing Error: Do Not Exceed One Tablet Daily
The FDA-approved dosing for suzetrigine is strictly one tablet (maximum) per 24 hours for adults and children 12 years and older—there is no loading dose regimen of two pills initially. 1
FDA-Approved Dosing Instructions
The official FDA label for suzetrigine explicitly states 1:
- Adults and children 12 years and over: 1 tablet daily with a full glass of water
- Not more than 1 tablet in 24 hours
- No mention of a loading dose or initial two-pill regimen exists in the approved labeling
Critical Safety Concern for Patients with Seizure History
For patients with a history of seizures or neurological disorders, exceeding the maximum daily dose of suzetrigine poses unknown and potentially serious risks, as this population has not been adequately studied with this medication. The dosing confusion you've encountered appears to be a medication error that must be corrected immediately.
Why This Matters for Seizure Patients
- No safety data exists for suzetrigine in patients with seizure disorders, as this is a newly FDA-approved medication (2025) 2, 3
- The FDA label specifically instructs patients to "not take more than directed" and warns that "taking more than directed may cause drowsiness" 1
- Historical guidance from the CDC regarding other medications affecting the nervous system emphasizes that patients with seizure disorders should be observed closely when taking any new medication 4
Immediate Action Required
Contact the prescribing physician immediately to clarify the correct dosing regimen. The instructions stating "two pills the first dose and then one pill every 12 hours" directly contradict FDA-approved labeling and would result in:
- An initial dose of 2 tablets (200% of maximum daily dose)
- Subsequent dosing of 2 tablets per day (200% of maximum daily dose)
This represents a potentially dangerous overdosing scenario 1.
Additional Precautions for This Patient Population
- Patients with liver or kidney disease should ask a doctor before use, as dose adjustments may be necessary 1
- The medication should be stopped immediately if nervousness, dizziness, or sleeplessness occurs 1
- Never divide, crush, chew, or dissolve the tablet 1
Common Pitfall to Avoid
Do not confuse suzetrigine dosing with other pain medications that may have loading dose regimens. Suzetrigine's mechanism as a selective NaV1.8 sodium channel inhibitor is unique, and it achieves therapeutic effect without requiring a loading dose 3.