Lacosamide

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Lacosamide

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Treatment option: Seizure, Epilepsy

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Lacosamide

Property Description
Active Ingredient Lacosamide (INN)
Form Tablets, Oral solution, Intravenous (IV) solution
Pharmacological Class Antiepileptic Drug (AED) / Anticonvulsant
Common Use Management of abnormal electrical activity in the brain
Origin Synthetic, Functionalized amino acid derivative

What Type of Medicine is Lacosamide?

Lacosamide is a synthetic, single-active-ingredient medicine classified as an Antiepileptic Drug (AED), also commonly known as an anticonvulsant. It is structurally unique, recognized as a functionalized amino acid derivative, which distinguishes its mechanism from many older seizure management medications. This compound represents a modern, targeted approach in pharmacology, aiming to stabilize the hyperexcitable nerve cell membranes within the central nervous system. Lacosamide is clinically recognized as an effective agent in its class. The general purpose of this medicine is to reduce the brain's predisposition to generate and propagate rapid, abnormal electrical activity.

Composition and Available Pharmaceutical Forms

The sole active ingredient is the chemical substance, Lacosamide, designated by the International Nonproprietary Name (INN). Lacosamide is a versatile medicine prepared for distinct administration needs; it is available in formulations that include oral tablets, an oral solution (syrup), and an intravenous (IV) solution. Both oral and parenteral forms are available, highlighting its utility in diverse patient care scenarios, such as when an individual cannot take medication orally. This range of dosage forms and the availability of the parenteral route are clinically essential for maintaining continuous care.

Lacosamide and Neuronal Stability

Lacosamide's function is centered on providing targeted neuronal stability by modulating the electrical signaling of nerve cells. The drug exerts its effect by selectively enhancing the slow inactivation of specialized protein gates, known as voltage-gated sodium channels (NaV channels). This mechanism limits the nerve cell's ability to engage in sustained, high-frequency electrical firing. By acting primarily on hyperactive neurons, Lacosamide dampens the underlying excessive electrical discharge, supporting the overall goal of maintaining electrical balance in the central nervous system.

Regulatory References

  1. Vimpat (Lacosamide) - EMA EPAR
  2. Vimpat (Lacosamide) EPAR

What side effects are possible with Lacosamide?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and safety characteristics of Lacosamide, strictly based on government regulatory documents.

Adverse Reaction Classifications

Adverse reactions are classified by the frequency observed in clinical studies:

  • Very Common (1/10): Dizziness, Headache, Nausea, and Diplopia (double vision).
  • Common (1/100 to < 1/10): Vomiting, Diarrhea, Somnolence (sleepiness), Tremor, Vertigo (sensation of spinning), Balance disorder, and Blurred vision.
  • System-Organ Classes (SOC): Adverse effects primarily involve the Nervous system, Gastrointestinal tract, Eyes, Psychiatric system, and Cardiovascular system.

Serious Safety Considerations

The official labeling highlights specific serious risks, including dose-related prolongations of the PR interval, which can lead to Cardiac conduction abnormalities (such as first-degree AV block). Lacosamide is also associated with an increased risk of Suicidal ideation and behavior, a class effect documented for antiepileptic drugs. Additionally, a rare but severe Multiorgan Hypersensitivity Reaction (DRESS) is an identified safety risk.

Population and Contextual Notes

The most common central nervous system effects, like dizziness, are often dose-related and tend to occur or intensify during the initial dose titration (escalation) phase. Use is generally not advised in patients with severe hepatic impairment. Lacosamide is contraindicated in patients with a known second- or third-degree Atrioventricular (AV) block.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with Lacosamide may lead to severe and life-threatening clinical manifestations primarily affecting the central nervous and cardiovascular systems, as documented in official regulatory labeling.

Documented Overdose Manifestations

Overdose presentations involve signs of central nervous system toxicity, including seizures (such as generalized tonic-clonic seizures), profound somnolence, confusion, and a severely decreased level of consciousness that can progress to coma. Common general signs such as dizziness and vomiting have also been officially reported.

Severe and Life-Threatening Outcomes

The most serious outcomes are cardiovascular in nature. Overdose can result in severe high-degree Atrioventricular (AV) block, life-threatening ventricular tachyarrhythmias, and Cardiac Arrest. Official documentation notes that fatal overdoses have occurred. These severe events are associated with marked electrocardiogram findings such as prolongation of the PR interval and QRS duration.

Emergency Action Required

Due to the significant risk of severe cardiac and neurological complications, immediate medical attention must be sought for any suspected overdose. Individuals must contact a Poison Control Center or emergency services right away. Management involves general supportive care and continuous monitoring of vital signs. No specific antidote is known for Lacosamide overdose. Standard decontamination procedures are indicated, and hemodialysis may be considered as it effectively removes the medicine from the plasma.

Therapeutic Uses of Lacosamide

Quick Facts: Uses of Lacosamide

  • May help manage: Partial-onset seizures in adult and pediatric patients.
  • May be used for: Primary generalized tonic-clonic seizures as an add-on therapy.
  • Therapeutic Goal: Works to address the occurrence and severity of certain seizure types.

Lacosamide is a prescription medication utilized to support the management of epilepsy by addressing specific seizure activity in the brain. The drug is indicated for use in adult and pediatric patients, age four years and older, for the treatment of partial-onset seizures. This type of seizure begins in a limited area on one side of the brain. The medication can be used alone or in combination with other treatments for this purpose.

Additionally, lacosamide is indicated as an adjunctive (add-on) therapy in adult and pediatric patients, age four years and older, to help control primary generalized tonic-clonic seizures. These seizures involve the entire body and are also known as grand mal seizures. The overall therapeutic goal of lacosamide is to offer potential for effective relief and help control the occurrence of these seizure types, contributing to better seizure management.

Eligibility and Restrictions for Use

Eligibility and Contraindications for Lacosamide

Official regulatory information defines specific populations that are eligible for treatment and those for whom use is prohibited or restricted.

Absolute Contraindications

Lacosamide must not be used in patients with:

  • Known hypersensitivity to the active substance or any excipients.
  • Known second- or third-degree atrioventricular (AV) block (a type of heart rhythm disorder).

Age-Related Eligibility

The minimum approved age varies by seizure type and region:

  • Partial-Onset Seizures: Approved for patients 1 month of age and older (US) or 2 years of age and older (EU).
  • Primary Generalized Tonic-Clonic Seizures (PGTCS): Approved for patients 4 years of age and older (consistent in US and EU).

Condition-Based Restrictions

Use is not recommended in patients with severe hepatic impairment. Dose adjustments and a maximum daily dose are required for patients with severe renal impairment or mild to moderate hepatic impairment. Additionally, ECG monitoring is recommended for patients with underlying proarrhythmic conditions or those taking medications that affect cardiac conduction.

Physiological Status

  • Pregnancy: The drug is generally classified as Pregnancy Category C; enrollment in the Antiepileptic Drug Pregnancy Registry is encouraged.
  • Lactation: It is not known if Lacosamide passes into human breast milk.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Lacosamide has documented interactions with other medicines that require careful management or monitoring. These interactions fall into two main categories: those affecting cardiac conduction and those involving drug metabolism.


1. Interactions Affecting Cardiac Conduction

  • Medicines that Prolong the PR Interval: Co-administration with drugs known to prolong the PR interval on an electrocardiogram (ECG) must be approached with caution due to the potential for additive effects on cardiac conduction. Examples include specific antiarrhythmics (e.g., Class I antiarrhythmic drugs), beta-blockers, and some calcium channel blockers.
  • Restriction: An ECG is recommended before starting treatment and after reaching the maintenance dose when Lacosamide is used concomitantly with products affecting cardiac conduction, especially in elderly patients or those with underlying heart conditions.

2. Interactions Affecting Drug Metabolism

  • Enzyme Inducers: Strong enzyme-inducing antiepileptic drugs (e.g., Carbamazepine, Phenytoin, Phenobarbital) or other strong inducers (e.g., Rifampicin, St John's wort) can moderately reduce the overall systemic exposure of Lacosamide. Monitoring should be considered when initiating or discontinuing these products.
  • Enzyme Inhibitors: Strong inhibitors of Cytochrome P450 enzymes CYP2C9 and CYP3A4 (e.g., Fluconazole, Itraconazole, Ritonavir) may lead to increased exposure of Lacosamide. Caution is recommended with co-administration, and dose adjustments may be needed in patients with impaired kidney or liver function.

Mechanism of Action

Selective Enhancement of Neuronal Slow Inactivation

Lacosamide's primary mechanism involves acting as a selective modulator on neuronal voltage-gated sodium channels ( Na V channels). The drug specifically enhances the slow inactivation state of these channels, causing a hyperpolarizing shift in their voltage dependence. This action fundamentally restricts the availability of the channels during sustained firing, which limits the persistent sodium current ( I Na) and results in a reduction of hyperexcitability in the nerve cell membranes.

Regulation of Cellular Signaling Components

Beyond the main ion channel effect, the drug also engages in a secondary mechanism by binding to the neuronal phosphoprotein Collapsin-Response Mediator Protein-2 (CRMP-2). This interaction contributes to the modulation of neuronal excitability by influencing key components involved in the regulation of cellular signaling and network organization. The result is a more regulated state within neural signaling pathways, which functionally limits the propagation of abnormal electrical discharges.

Use-Dependent Limitation of High-Frequency Firing

The mechanistic focus on slow inactivation grants Lacosamide a use-dependent quality, meaning its effect is preferentially exerted on hyperactive neurons that are firing repetitively. This targeted intervention limits the cell's capacity for sustained discharges with a lesser influence on normal, low-frequency electrical activity. This specific pattern of mechanistic action results in the regulation of electrical activity in neural networks.

Dosage and Administration Information

Lacosamide is administered by the oral route (as tablets or oral solution) or via intravenous (IV) infusion. Oral doses should be taken twice daily, approximately 12 hours apart, and may be consumed with or without food. The IV route is restricted to situations where oral administration is temporarily infeasible.

Official Dosing and Administration

Patient Group Initial Dosing Schedule Titration and Maintenance Rules
Adults (≥17 years) 50 mg to 100 mg twice daily. An alternate regimen of a single 200 mg loading dose may be used. The dose should be increased by 50 mg twice daily (100 mg/day) at weekly intervals, based on response, up to a maximum recommended dose of 200 mg twice daily (400 mg/day).
Pediatric Patients Dosage is determined by body weight (in kg) and administered twice daily. Specific dosing increments apply to weight categories (e.g., 6 kg to <50 kg). Doses are increased no more frequently than once per week.

Procedural Steps: Tablets must be swallowed whole. The oral solution requires a calibrated measuring device, not a household spoon, for accurate dosing. IV infusion must be administered slowly over 30 to 60 minutes. When discontinuing treatment, the dose must be gradually withdrawn over at least one week to minimize the risk of increased seizure frequency.

Missed Dose Instructions: If a dose is missed, take it immediately. However, if the missed dose is noticed within 6 hours of the next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lacosamide


Evidence for Use in Partial-Onset Seizures (Focal Seizures)

Research exploring lacosamide for partial-onset seizures has primarily relied on multiple Randomized Controlled Trials (RCTs). These short-term studies examined adding lacosamide to a person's existing treatment regimen against a placebo to observe patterns in outcomes. Researchers also conducted comparative trials to examine the use of lacosamide as the single initial treatment (monotherapy) against another anti-epileptic medicine. Studies monitored outcomes such as the percent change in seizure frequency and the proportion of participants who experienced a certain level of measured change in seizure frequency.

The primary efficacy data were gathered from trials with limited follow-up durations, typically a few months. Therefore, long-term outcomes are not fully established based solely on these initial trials. The research also highlights that results apply only to the populations studied and do not fully characterize long-term outcomes in a variety of real-world circumstances.


Evidence for Use in Primary Generalized Tonic-Clonic Seizures (PGTCS)

The research framework for the adjunctive use of lacosamide in Primary Generalized Tonic-Clonic Seizures (PGTCS) relies heavily on a single pivotal Phase 3 controlled trial. This study was designed to measure a time-to-event endpoint, meaning research examined the time that passed before a participant experienced their second PGTCS event. Findings from this pivotal research describe patterns observed in the studies related to this time before a second PGTCS occurred.

Since the evidence base for this specific indication rests upon the findings of one main large-scale trial, data for certain groups remain insufficient. While the study provided information over its roughly six-month treatment period, long-term effects are not fully established, and continued observation in less-controlled settings is necessary to understand the sustainability of the observed symptom patterns.


Evidence in Special Study Populations

Research has explored the use of lacosamide in specific age groups outside of the core adult populations. Lacosamide was evaluated in Children and Adolescents (age four years and older) for both partial-onset and PGTCS. Research was also applied in studies examining infants as young as one month of age who were experiencing partial-onset seizures. However, relative to the evidence available for adults, the sample sizes were modest in the studies involving younger children, and data for certain groups remain insufficient.

Key Studies & References

  1. Efficacy and safety of lacosamide in partial-onset seizures: a pooled analysis of three phase II/III studies

Frequently Asked Questions (FAQ)

Common questions about Lacosamide (FAQ)


Q: Is Lacosamide considered a first-line or add-on treatment for epilepsy?

According to official product information, Lacosamide is authorized for use in two primary ways for partial-onset seizures. It can be used on its own (monotherapy) as the single initial treatment, or it can be used as an add-on (adjunctive) therapy taken alongside other anti-epileptic medicines.


Q: What is the difference between brand-name Vimpat and generic Lacosamide?

Vimpat is the brand-name product that contains the active ingredient, lacosamide. Generic versions containing the same active substance have been approved by regulatory bodies like the FDA. These generic products are required to be bioequivalent to the brand-name product, which means they are expected to work similarly in the body.


Q: Is Lacosamide a controlled substance, and what does that mean for patients?

In the United States, lacosamide is classified as a Schedule V controlled substance by the Drug Enforcement Administration (DEA). This classification indicates that the medicine has a low potential for abuse relative to substances in Schedule IV.


Q: Does taking Lacosamide often lead to memory problems or cognitive 'fogginess'?

Official regulatory documents describe adverse reactions involving the nervous system, which include memory impairment, cognitive disorder, and disturbance in attention. Other commonly reported reactions that may affect clarity of thought are dizziness and sleepiness.


Q: Are mood changes like anxiety or depression associated with Lacosamide use?

Regulatory documents list several psychiatric adverse reactions associated with the medicine. These include common reactions like depression and confusional state. Less common but serious risks such as aggression and suicidal ideation or behavior are also noted in official product information.


Q: What are the signs of a serious skin reaction related to Lacosamide?

Lacosamide is associated with a risk of a rare, severe allergic reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms). Signs that are described in official warnings may include a fever, a widespread rash, and potential swelling of the face or lymph nodes. This type of reaction can also potentially involve damage to internal organs.


Q: How does Lacosamide interact with hormonal contraceptives?

Regulatory guidance suggests that any drug that affects the metabolism of hormones, such as progestins or estrogens used in contraceptives, could potentially reduce the contraceptive's effectiveness. The documents suggest that this potential effect could compromise the contraceptive’s effectiveness by altering hormone levels.


Q: Does alcohol consumption interact with Lacosamide in a significant way?

Official product information indicates that consuming alcohol while taking lacosamide may lead to an increase in certain central nervous system side effects. These can include heightened feelings of dizziness, drowsiness, and confusion.


Q: What might cause Lacosamide to suddenly become less effective for seizure control?

The overall effectiveness of the medication may be reduced if it is taken at the same time as certain other medicines. This effect is attributed to strong enzyme-inducing antiepileptic drugs (such as Carbamazepine) which are described as being able to decrease the total amount of lacosamide available in the body.


Q: Is it common to have seizures continue after starting Lacosamide treatment?

Official clinical trial data indicates that while the medication is shown to reduce seizure frequency, achieving a completely seizure-free state is not observed in all participants. Studies showed that a certain proportion of participants achieved a 50% or greater reduction in seizures.


Q: What is the typical half-life of Lacosamide in the body?

Official pharmacological summaries indicate that the drug is rapidly and completely absorbed after it is taken orally. Lacosamide has an elimination half-life of approximately 13 hours in the body.


Q: Is the oral solution as effective as the tablet form of Lacosamide?

Official documents confirm that studies support the bioequivalence of the oral solution and the tablet formulation, which suggests they are expected to be equally effective.


Q: What research themes have been explored regarding Lacosamide's use in refractory epilepsy?

Clinical trials have often involved participants who are taking multiple concomitant antiepileptic drugs and still experience uncontrolled seizures. This aligns with research themes exploring drug-resistant or refractory epilepsy. Dedicated research has also focused on children who have uncontrolled seizures.


Q: What information is available regarding Lacosamide's use in patients with intellectual disabilities?

While not the primary population for initial clinical trials, post-marketing and real-world evidence has been gathered for this group. These studies generally suggest similar efficacy and tolerability outcomes compared to the general population, based on post-marketing or real-world evidence.


Q: Are there specific over-the-counter medications that should be avoided with Lacosamide?

Regulatory resources indicate that certain common medications, including some available over-the-counter, may interact with lacosamide. For example, some sources mention ingredients such as Paracetamol (Acetaminophen) and Diphenhydramine (Benadryl). These interactions are noted in regulatory resources due to a potential for interaction that may necessitate professional assessment or adjustment of the drug regimen.


How should Lacosamide be stored and disposed of?

Official Storage and Disposal Instructions

Lacosamide (tablets and oral solution) must be stored at Controlled Room Temperature, maintained between 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C (86 F). The medicine must be kept in its tightly closed container, away from excess heat and moisture.

Product Form Specific Storage/Stability Rule
Oral Solution Do not freeze. Discard any unused portion 6 months after first opening the bottle.
IV Solution When mixed, the solution is stable for up to 24 hours at room temperature.

All forms of lacosamide must be kept out of the sight and reach of children. Unused or expired medicine should not be flushed down the sink or toilet. Disposal should follow the official guidance of using a drug take-back program or mixing the medicine with an undesirable substance before discarding in the household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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