Section 01 · Monograph
Lacosamide
Reviewed Nov 2026FDA label
VimpatNa+ channel modulator
- Forms
- Tab: 50, 100, 150, 200mg | Sol: 10mg/mL | IV: 10mg/mL
- Dose
- 100-400mg/day
- MOA
- Enhances slow Na+ inactivation
Indications
- Treatment of partial-onset seizures, age 1 month and older (monotherapy or adjunctive)FDA-labeled
- Adjunctive therapy for primary generalized tonic-clonic seizures, age 4 years and olderFDA-labeled
Mechanism of Action
- Selectively enhances slow inactivation of voltage-gated sodium channels (distinct from the fast inactivation targeted by traditional sodium channel blockers), stabilizing hyperexcitable neuronal membranes and reducing repetitive neuronal firing without affecting fast inactivation
Full Dosing
Adult / usual
- Adults, monotherapy: initiate 100mg BID; may titrate by 50mg BID at weekly intervals to a usual maintenance dose of 150-200mg BID (max 400mg/day)
- Adults, adjunctive therapy: initiate 50mg BID; titrate by 50mg BID weekly to a usual maintenance range of 100-200mg BID (max 400mg/day)
- Available as oral tablet, oral solution, and IV injection at equivalent doses — IV is a substitute when oral administration is temporarily not feasible; infuse over 15-60 minutes
- Obtain baseline ECG before initiation and consider a follow-up ECG after titration to steady-state maintenance dose, especially in patients with cardiac conduction risk factors
Renal
- Renal impairment: reduce maximum dose by ~25% if CrCl <30 mL/min; supplemental dose after hemodialysis session should be considered
Hepatic
- Hepatic impairment: reduce maximum dose by ~25%; not recommended in severe hepatic impairment
Contraindications
- Known hypersensitivity to lacosamide or any component of the formulation
Drug Interactions
- Strong CYP3A4 or CYP2C9 inhibitors/inducers may alter lacosamide exposure — dose adjustment may be warranted
- Additive PR-interval prolongation/cardiac conduction effects with other drugs affecting cardiac conduction (beta-blockers, calcium channel blockers, other sodium channel blocking antiseizure drugs) — use caution and consider ECG monitoring
- Relatively few clinically significant pharmacokinetic interactions with other AEDs compared to older agents
Adverse Effects
- Common: diplopia, dizziness, headache, nausea, somnolence, ataxia
- PR interval prolongation (dose-dependent); atrioventricular block, bradycardia, and rare cases of ventricular tachyarrhythmia including fatal events have been reported
- Caution and baseline/follow-up ECG advised in patients with known conduction abnormalities, severe cardiac disease, or those on concomitant PR-prolonging drugs
- Dizziness/ataxia may increase fall risk
- Suicidal ideation/behavior (class effect); rash and DRESS (drug reaction with eosinophilia and systemic symptoms) reported
- Multiorgan hypersensitivity reactions reported postmarketing
Monitoring Parameters
- Baseline ECG before initiation and at steady-state maintenance dose in patients with cardiac conduction risk factors or those on concurrent PR-prolonging medications
- Signs/symptoms of syncope, bradycardia, or AV block, particularly during up-titration
- Mental status for mood changes or suicidal ideation
Pregnancy & Lactation
- Animal studies showed developmental toxicity at clinically relevant exposures; human data are limited and insufficient to establish drug-associated risk
- Encourage enrollment in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334)
- Lacosamide is present in breast milk; monitor breastfed infants for excess sedation or feeding difficulty