EpilepsyRx

Lacosamide

Vimpat

DailyMed-verified antiseizure indications

Indication / use

Label / evidence summary
Vimpat: focal-onset seizures from age 1 month; adjunctive treatment of primary generalized tonic-clonic seizures from age 4 years. Motpoly XR: focal-onset seizures, and adjunctive treatment of primary generalized tonic-clonic seizures, in adults and pediatric patients weighing at least 50 kg.
Role
Maintenance
Class
Enhancement of slow sodium-channel inactivation in vitro

Indications checked 26 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.

Formulations & strengths

U.S. products unless another country is named. Strengths are per unit or stated volume.

Brand & formulation labels

Each link names the product and formulation it covers. Archived labels do not establish current availability.

Dosing & administration

Adult / product-specific schedule
Age ≥17: focal monotherapy starts 100 mg twice daily; adjunctive focal/PGTC starts 50 mg twice daily. Increase by 50 mg twice daily weekly; maintenance 150–200 mg twice daily for monotherapy or 100–200 mg twice daily adjunctively.
Pediatric
Pediatric ≥50 kg: start 50 mg twice daily, then indication-specific maintenance. 30–<50 kg: start 1 mg/kg twice daily → 2–4 mg/kg twice daily; 11–<30 kg: start 1 → 3–6 mg/kg twice daily; 6–<11 kg: start 1 → 3–6 mg/kg twice daily (focal only). <6 kg: oral start 1 → 3.75–7.5 mg/kg twice daily; IV start 0.66 → 2.5–5 mg/kg THREE times daily (focal only). Increase no more often than weekly; see exact table.
Titration / repeat dosing
Adults: 50 mg twice daily adjunctively or 100 mg twice daily as monotherapy; increase by 50 mg twice daily no more often than weekly to 100–200 mg twice daily. Weight-based weekly steps apply below 50 kg.

Dose adjustment & concentrations

Renal impairment
Reduce maximum dose by 25% in severe impairment/ESRD; consider supplement after hemodialysis.
Hepatic impairment
Reduce maximum dose by 25% in mild–moderate impairment; not recommended in severe impairment.
Serum reference information
Mayo reference interval 1–10 mcg/mL for patients receiving therapeutic doses. An individual clinical target is not established by this laboratory interval.

Safety

Boxed warning
No boxed warning.
Contraindications
None listed in the linked U.S. Vimpat label; cardiac warnings still apply.
Serious precautions & monitoring
PR prolongation and arrhythmias: ECG before starting and after titration in proarrhythmic conditions or with conduction-affecting medications. Dizziness, ataxia, syncope and DRESS.

Common / selected adverse effects

  • Dizziness
  • Headache
  • Nausea
  • Diplopia
  • Fatigue

Drug interactions: toxicity & clinical action

Partner / combinationClinical effectClinical action
Other sodium-channel blockers, beta-blockers, calcium-channel blockers or other conduction-affecting drugsAdditive PR prolongation, bradycardia or AV block; dizziness/ataxia can also be additive.ECG before treatment and after titration in at-risk patients; monitor particularly with IV dosing.
Strong CYP3A4/CYP2C9 inhibitors in renal/hepatic impairmentCan further increase exposure.Consider dose reduction and monitor tolerability.

Pregnancy & contraception

Fetal / neonatal risk
Human lacosamide pregnancy data are insufficient to establish risk. Animal studies found developmental mortality, growth deficits and neurotoxicity at clinically relevant exposures.
Contraception
At 400 mg/day, lacosamide did not meaningfully alter the pharmacodynamics of the studied ethinylestradiol/levonorgestrel contraceptive; ethinylestradiol peak concentration increased by 20%.

Clinical evidence

Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.

Direct pivotal trial Guideline-supported off-label use

Trial summary

Study design / duration
Three multicenter, randomized, double-blind, placebo-controlled adjunctive focal-seizure trials with 8-week baseline, 4–6-week titration, and 12-week maintenance; primary endpoint was seizure-frequency reduction per 28 days.
Primary endpoint
No single pivotal endpoint is identified in the cited source.
Results
Three adjunctive focal-seizure trials showed median 28-day seizure reductions of about 27–40% at effective doses versus 10–21% with placebo; ≥50% responder rates were roughly 33–41% versus 18–26%.

Trial publications

Mechanism of action

  • Label-supported electrophysiology: selectively enhances slow inactivation of voltage-gated sodium channels, reducing channel availability during prolonged depolarization and limiting repetitive firing.
  • The human antiseizure mechanism is not fully established. Slow-inactivation selectivity describes the experimental observations; it should not be turned into an absolute claim of no fast-inactivation effects under any conditions.

Pharmacology

Adult values unless specified. Vd/F denotes apparent oral distribution volume.

Pharmacokinetics

Bioavailability
Approximately 100% absolute oral bioavailability; oral solution/tablet and 30–60-minute IV infusions provide comparable exposure.
Elimination half-life
Approximately 13 hours in adults with IR/IV treatment. Pediatric typical values depend on weight: 7.2 hours at 10 kg, 10.6 at 28.9 kg and 14.8 at 70 kg in the label model.
Volume of distribution
Approximately 0.6 L/kg.
Active metabolite(s)
None known: O-desmethyl-lacosamide has no known pharmacological activity.
Active-metabolite half-life
Not applicable — no clinically established active metabolite.
Protein binding
<15%
Metabolism / elimination
CYP2C19 contribution plus renal excretion; multiple pathways

Keep IR, IV and extended-release product schedules distinct; dose adjustment depends on organ function.

Molecular structure

Molecular structure of Lacosamide
Principal compound; salt and product forms may differ.
NIH PubChem structure and record ↗

Product history

Initial U.S. approval
2008
Brands
Vimpat
Manufacturer / marketer
UCB (Vimpat)
Generic availability
Yes
Related drugs
Related functionally to sodium-channel blockers, but selectively enhances slow inactivation.

Sources & review status

Representative sources are selected product labels, not an exhaustive list of generic manufacturers. Consult the exact product and formulation prescribed. Brand-name package inserts are linked separately.

Brand reference: Vimpat tablets / solution / injection ↗

Indications and DailyMed PDFs checked: 2026-09-26. Other profile sources reviewed: 2026-09-15 · label revision noted at that review: 5/2026. This is a draft reference; final review is pending.

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