Clobam

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Clobam

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Clobam

Property Description
Active Ingredient Clobazam
Pharmacological Class Anticonvulsant, Benzodiazepine
Primary Forms Oral Tablet, Oral Suspension
General Purpose Seizure control (Adjunctive therapy)
Origin Synthetic

Clobam: Definition, Active Ingredient, and Drug Class

Clobam is a synthetic, prescription-only medication whose active component is the generic substance Clobazam. This agent is classified within the antiepileptic drug (AED) category and structurally belongs to the 1,5-Benzodiazepine class. As a pharmacological agent, Clobazam is utilized for seizure control.

As a single-ingredient compound, Clobazam is a derivative of a structural class known for its central nervous system activity. Its classification as an AED indicates that its principal role is to help stabilize neurological function. Its synthetic origin ensures a standardized, precise composition. Unlike some other drugs in its class, Clobazam’s primary positioning has historically been focused on the management of seizure disorders.


Available Forms and General Therapeutic Purpose

Clobazam is primarily designed for oral administration and is available as a solid tablet and a liquid oral suspension. The availability of both forms, including the liquid suspension, is a key differentiating feature that addresses the need for precise dosing in certain patient groups.

Its general purpose is to act as an agent to help control and reduce the frequency of seizures in individuals with epilepsy or related seizure disorders. Its therapeutic role includes the management of specific seizure types that may be resistant to other treatments. This means that Clobazam is specifically utilized to provide stability and reduction in seizure frequency when added as an adjunctive therapy to existing regimens.

Regulatory References

  1. MedlinePlus, NIH

What side effects are possible with Clobam?

Possible Side Effects and Safety Information

Official regulatory documents classify the safety profile of this medicine by the frequency of reported adverse reactions and by major, clinically significant risks.


Serious and Clinically Significant Risks

  • Risk from Opioid Use: The drug carries a Boxed Warning regarding the risk of severe respiratory depression, profound sedation, coma, and death when used concurrently with opioid medicines or other Central Nervous System (CNS) depressants, including alcohol. Prescribing should be reserved for cases where alternative options are inadequate, and close monitoring is required.
  • Serious Skin Reactions: Rare, life-threatening skin reactions have been reported, including Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). These reactions can result in permanent harm (such as blindness) or death and are most likely to occur within the first eight weeks of starting treatment.
  • Dependence and Withdrawal: The use of this medicine exposes patients to risks of abuse, misuse, addiction, and physical dependence. Abrupt discontinuation or rapid dose reduction can precipitate serious, life-threatening withdrawal symptoms, including seizures. A gradual dosage reduction is required upon discontinuation to minimize these risks.
  • Suicidal Behavior and Ideation: Monitoring is necessary for the emergence or worsening of depression, unusual changes in mood or behavior, or suicidal thoughts/actions, which is an established risk for anticonvulsant medicines.

Common Adverse Reactions

The most commonly reported adverse reactions that occurred more frequently than with placebo in clinical trials include:

Frequency Category Examples of Adverse Reactions (by System-Organ Class)
Very Common Somnolence/Sedation, Lethargy
Common Constipation, Drooling, Fever, Ataxia, Aggressive behavior, Fatigue, Irritability

Other reported reactions across various system-organ classes include changes in appetite, weight gain, disturbances in attention, and blurred vision.

Overdose and Emergency Response

The official regulatory profile for Clobazam overdose is defined by the progression of Central Nervous System (CNS) depression. Documented clinical manifestations of overdose, as described in prescribing information, include a spectrum of signs: somnolence, lethargy, confusion, ataxia (lack of coordination), slurred speech, and blurred vision.

Overdose may rapidly progress to severe, life-threatening outcomes, including profound respiratory depression (shallow or slowed breathing), significant hypotension, and ultimately coma. The risk of a fatal outcome is explicitly documented, and this risk is significantly amplified in cases where the overdose involves the co-ingestion of alcohol, opioid medicines, or other CNS depressants.

Immediate medical attention is a mandatory regulatory requirement. Urgent help must be sought if signs of severe toxicity are observed, such as excessive sleepiness, unresponsiveness, or any indication of compromised breathing. Emergency services must be contacted immediately if the individual exhibits shallow or stopped breathing or loss of consciousness. Medical management is defined in regulatory documents as symptomatic and supportive treatment, with continuous monitoring for respiratory depression and sedation being essential in the clinical setting.

Therapeutic Uses of Clobam

Clobam (Clobazam): Main Uses and Benefits

Clobazam is an established prescription medication used in the management of seizure conditions. Its primary approved role is the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients who are two years of age and older. Adjunctive therapy indicates that Clobazam is used alongside other existing anti-seizure medications to assist in achieving seizure control.

Treatment with Clobazam may contribute to a reduction in the frequency of various seizure types characteristic of LGS. It is intended to provide a measure of benefit in helping to stabilize the condition. The overall goal of this treatment is to support the patient's seizure management plan and contribute to overall functional health.


Quick Facts

  • Approved Use: Adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS).
  • Patient Age: Indicated for use in individuals aged two years and older.
  • Therapeutic Goal: To assist in reducing the frequency of seizures.

Eligibility and Restrictions for Use

Clobam (clobazam) is a prescription medication primarily used as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. It may also be used to treat other forms of epilepsy or severe anxiety, depending on a healthcare provider's assessment.


Who Should Not Use Clobam?

Clobam is contraindicated and should not be used by certain individuals due to the risk of serious side effects. Patients should inform their doctor of all pre-existing conditions and medications.

Condition / Factor Reason for Avoidance / Caution
Allergy/Hypersensitivity To clobazam or other benzodiazepines.
Severe Hepatic Impairment The liver metabolizes the drug; severe impairment can lead to toxic accumulation.
Sleep Apnea (Severe) Risk of respiratory depression and exacerbation of the condition.
History of Substance Abuse Increased risk of dependence and misuse.
Pregnancy/Breastfeeding Potential for fetal harm, neonatal withdrawal, and drug transfer via breast milk.

Special Caution: Elderly patients and those with respiratory issues (like Chronic Obstructive Pulmonary Disease, COPD) may require lower starting doses due to increased sensitivity to the drug's sedative and respiratory depressant effects.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Clobazam (Clobam) has officially documented interaction patterns primarily categorized by pharmacodynamic and pharmacokinetic mechanisms, strictly based on regulatory prescribing information.


Regulatory Interaction Classifications

Classification Interacting Agents / Classes Restriction Summary
Contraindicated Opioids, Acute Alcohol Intoxication Risk of profound sedation, respiratory depression, coma, and death; prohibited co-administration.
PK Exposure Increase Strong/Moderate CYP2C19 Inhibitors Increases exposure to the active metabolite, N-desmethylclobazam (norclobazam).
PD Potentiation CNS Depressants (e.g., Anxiolytics, Antipsychotics, other Anticonvulsants) Additive effect leading to enhanced sedation and central depressive effects.

Pharmacokinetic Effect

Clobazam is a weak inhibitor of CYP2D6, which may lead to increased plasma concentrations of co-administered medicines that are substrates of that enzyme, such as certain antidepressants. Conversely, as a weak inducer of CYP3A4, Clobazam may diminish the effectiveness of hormonal contraceptives, requiring additional non-hormonal protection. Alcohol is noted to increase Clobazam blood levels by approximately 50%. Furthermore, Cannabidiol (CBD) significantly increases the concentration of the active metabolite, N-desmethylclobazam, via CYP2C19 inhibition. Population considerations note that CYP2C19 Poor Metabolizers exhibit higher active metabolite exposure.

Mechanism of Action

Clobazam functions as a positive allosteric modulator (PAM) that acts within the central nervous system by targeting the GABA A receptor complex. This binding occurs at a site distinct from the primary binding pocket for the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA). The interaction increases the affinity and functional effect of GABA, thereby increasing the frequency of chloride ion (Cl^-) channel opening within the receptor complex.

This influx of negatively charged ions causes neuronal hyperpolarization, which decreases the intrinsic excitability of the postsynaptic neuron and reduces the likelihood of action potential generation. Furthermore, Clobazam exhibits a degree of selectivity for GABA A receptors containing specific subunits, notably mathbfalpha 2. This subunit-level targeting modulates activity in specific inhibitory circuits, facilitating the net increase of inhibitory tone associated with hyperexcitable neuronal discharge.

Dosage and Administration Information

How to Use Clobam (Clobazam): Official Administration and Dosing

Clobam (Clobazam) is approved solely for oral administration and is used as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS). All instructions on dosing, frequency, and preparation are based on official regulatory documents.


Approved Forms and Intake Instructions

Dosage Form Available Strengths Administration Note
Oral Tablet 5 mg, 10 mg, 20 mg Can be taken whole, broken, or crushed and mixed in applesauce.
Oral Suspension 2.5 mg/mL Must be shaken well and administered using the provided dosing syringe.

Both the tablet and oral suspension forms can be taken with or without food.

Dosing and Titration Schedule

Dosing is highly individualized and initiated at a low dose, with a required slow, incremental increase (titration) to manage tolerability and reach the effective daily dose. Dose adjustments must occur no more rapidly than weekly.

Body Weight Group Standard Starting Dose Maximum Total Daily Dose
≤ 30 kg 5 mg once daily 20 mg/day (divided)
> 30 kg 10 mg (divided) 40 mg/day (divided)

Total daily doses greater than 5 mg must be administered in two divided doses per day (twice daily).

Population-Specific Use and Discontinuation

For older adults (geriatric patients), and those with mild to moderate hepatic impairment, the starting dose should be 5 mg/day. Titration for these groups should proceed slowly, aiming for half the standard maximum dose initially.

Treatment must never be stopped abruptly. Discontinuation requires a gradual taper, reducing the dose by 5 to 10 mg/day on a weekly basis, as specified in the official labeling.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Clobam

Evidence for Use in Lennox-Gastaut Syndrome (LGS)

Research exploring short-term symptom changes in conditions characterized by fluctuating manifestations, such as LGS, has primarily involved randomized, placebo-controlled trials. These studies were applied in studies examining patient-reported experiences and measured outcomes reflecting daily functioning and episodic changes. The population studied was evaluated in trials that included both children and adults who were already using at least one other anti-epileptic drug.

In these core short-term studies, research examined changes in the frequency of specific seizure types, such as drop seizures, over defined time intervals. Studies monitored changes measured during the study period, including the reported counts of episodic or acute changes and how symptoms evolved in the observed populations. These research findings contribute to the broader evidence landscape related to symptoms and their measurement.

Long-Term Follow-up and Durability of Response

Studies have explored the long-term use of Clobam through open-label extension studies, where participants were observed after the main trial finished. These studies monitored patients for up to several years. The evidence derived from these settings, where symptoms may vary in intensity, contributes to understanding symptom patterns over time.

The long-term data for Clobam were derived mainly from open-label environments, which do not include a placebo or comparison group. The long-term evidence quality varies across studies, and long-term effects are not fully established. Limited information is available for long-term outcomes related to aspects beyond seizure frequency, such as sustained daily functioning or outcomes reflecting daily functioning or activity level.

What Research Is Still Needed (Evidence Gaps)

Evidence derived from settings with varying symptom burdens includes gaps in several key areas. Follow-up durations were limited in the core, highest-quality studies, and long-term observational evidence does not offer the same level of certainty. Data for certain groups remain insufficient, and there is limited information for long-term outcomes on Clobam when used alone, as studies monitored its use primarily as part of a combination regimen. These findings contribute to the broader evidence landscape related to this condition, which is characterized by fluctuating manifestations.

Key Studies & References

  1. Efficacy and safety of clobazam in the treatment of seizures associated with Lennox-Gastaut syndrome: results of a phase III trial (OV-1012)

Frequently Asked Questions (FAQ)

Common questions about Clobam (FAQ)


Q: Can Clobam cause long-term memory problems?

Official information indicates that common side effects include disturbances in attention and sleepiness (somnolence or sedation). While these cognitive effects are noted in the safety profile, the official labeling does not specifically list long-term memory loss or amnesia as a common adverse reaction.


Q: What happens if I forget to take a dose of Clobam?

General patient information on drug administration advises that if a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next dose, the missed dose is usually skipped to return to the regular schedule. It is important that a double dose is not taken to make up for a missed one.


Q: Are there any specific foods or drinks I should avoid while taking Clobam?

According to the official product labeling, Clobam can be taken either with or without food. The label does not list any specific food restrictions or unique drink interactions. However, the concurrent use of Clobam with alcohol is contraindicated due to the severe risks of respiratory depression and profound sedation.


Q: Can Clobam affect sleep patterns, like causing insomnia or oversleeping?

Yes, regulatory documents report that Clobam can affect sleep patterns. Very common side effects include sedation and somnolence (feeling sleepy). Additionally, insomnia (difficulty sleeping) is also reported as a common adverse reaction in the safety profile.


Q: Can taking Clobam make me feel 'foggy' or less focused during the day?

Regulatory documents list disturbances in attention as a common adverse reaction. Since sedation and somnolence (sleepiness) are also very common, the combined effects may be experienced as reduced mental clarity or focus.


Q: Is Clobam ever prescribed for muscle spasms?

The approved indication for Clobam is the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. Information in the label does not explicitly list general muscle spasms as an approved use. Muscle spasms have been noted in regulatory documents as a potential symptom of overdose.


Q: What type of seizures is Clobam most effective for treating?

The primary official indication for Clobam is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS). This means it is used specifically as an add-on therapy for this severe form of childhood-onset epilepsy.


Q: Why is it important to have regular blood tests while on Clobam?

Regular blood tests may be necessary to measure the serum concentrations of clobazam and its active metabolite, N-desmethylclobazam, in the blood. These tests assist in adjusting the dose to help maintain effective levels while managing potential side effects.


Q: Can Clobam affect mood or cause emotional changes?

Yes, Clobam, like other anticonvulsant medicines, carries a warning about an increased risk of suicidal thoughts or behavior. Other common mood and emotional changes reported in studies include aggressive behavior and irritability.


Q: What is the experience of withdrawing from Clobam like?

Official warnings state that abrupt discontinuation exposes patients to the risk of serious withdrawal symptoms. These symptoms can be severe and may include new seizures, hallucinations, psychosis, anxiety, agitation, and extreme emotional changes.


Q: Does Clobam have a common interaction with birth control pills?

Yes, Clobam can potentially reduce the effectiveness of hormonal contraceptives, such as birth control pills. This is due to its effect as a weak inducer of the CYP3A4 liver enzyme. If hormonal contraceptives are used, it may be necessary to consider additional forms of non-hormonal protection.


Q: Is it normal to feel dizzy or unsteady when taking Clobam?

Yes, the official list of common side effects includes ataxia, which means a lack of coordination or feeling unsteady. This sense of unsteadiness is a commonly reported adverse reaction.


Q: Can Clobam cause weight gain or changes in appetite?

Regulatory documents report both changes in appetite and weight gain as adverse reactions in clinical trials. These effects are part of the known safety profile.


Q: Is it true that Clobam can make certain types of seizures worse?

The labeling does not explicitly state that Clobam makes certain seizures worse during continuous therapy. However, the regulatory documents require that the medication be withdrawn gradually to help minimize the risk of withdrawal seizures or seizure exacerbation.


Q: Does Clobam interact with over-the-counter cough or cold medicines?

Yes, Clobam can interact with certain over-the-counter (OTC) cold and cough medicines. This is because Clobam and some OTC medicines are Central Nervous System (CNS) depressants, and combining them can increase the risk of severe sedation and respiratory problems.


Q: Can Clobam be crushed or split if it's not a scored tablet?

Official administration instructions indicate that Clobam tablets can be administered whole, or they can be crushed and mixed in applesauce. The labeling does not restrict this practice only to tablets that are scored.


Q: Are there non-epilepsy conditions for which Clobam is sometimes considered?

Although the primary approved indication is for Lennox-Gastaut syndrome, Clobam is also mentioned in regulatory materials for use in severe anxiety. The main use remains focused on seizure management.


Q: Does Clobam affect the effectiveness of dental anesthetics?

Due to Clobam’s classification as a CNS depressant, concurrent use with other CNS depressants, including certain dental anesthetics, may increase the risk of side effects such as severe drowsiness or respiratory problems.


Q: Why do doctors recommend not driving until you know how Clobam affects you?

Official patient counseling states that due to the risk of impaired alertness, coordination, and judgment—caused by side effects like somnolence or sedation—activities requiring mental alertness, such as driving or operating machinery, should be avoided until the drug's effects are fully known.


Q: Is Clobam used to treat seizures in newborns or infants?

The approved indication for Clobam specifies its use in patients who are 2 years of age and older. Use in children younger than 2 years of age is not covered by the official label.

How should Clobam be stored and disposed of?

Storage Requirements

Clobazam must be stored at controlled room temperature, generally defined as 68 F to 77 F (20 C to 25 C). The medication must be kept in a closed container and protected from heat, moisture, and direct light.

It is mandatory to keep the product from freezing.

Oral Suspension Stability

Clobazam oral suspension must be stored in its original bottle in an upright position and the cap must be securely replaced after each use. Stability requirements dictate that any remaining oral suspension must be discarded after 90 days from the date the bottle was first opened.

Security and Disposal

As a controlled substance, clobazam must be stored in a safe place and always kept out of the sight and reach of children.

Disposal of any unused or expired product must be done in accordance with local requirements. Official guidance advises against discarding medicines via household waste or wastewater. Patients should consult a healthcare professional for proper disposal procedures.

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

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