Urbanil

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Urbanil

Medically reviewed

Laura Arias

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 Urbanil

Property Description
Active ingredient Clobazam (C16H13ClN2O2)
Form Tablet, Suspension, Oral Film
Pharmacological class Benzodiazepine / CNS Depressant
General purpose Reduces neuronal excitability and provides anticonvulsant effect
Origin Synthetic compound

What Type of Medicine is Urbanil (Clobazam)?

Urbanil is a synthetic pharmaceutical product containing the active ingredient Clobazam. Clobazam is classified as a long-acting benzodiazepine derivative, belonging to the group of central nervous system (CNS) depressants. The compound is structurally unique because it is a 1,5-benzodiazepine, a chemical feature involving its specific binding properties. This classification places it distinctively within the CNS depressant category, setting it apart from more common 1,4-benzodiazepines and defining its specific action profile in regulating brain activity.

How is Urbanil Composed and What is Its General Purpose?

Urbanil is designed as a single-ingredient product for the oral route of administration, available in multiple dosage forms, including the conventional tablet, as well as specialized preparations like a liquid suspension or an oral film. The availability of diverse forms is often considered for patient groups who may have difficulty swallowing conventional tablets. The general purpose of the medication is to reduce abnormal brain activity and neuronal excitability. It achieves this by acting as a positive allosteric modulator at the GABAA receptor, thereby enhancing the brain's natural calming mechanism. This action facilitates the stabilization of the central nervous system, providing a fundamental anticonvulsant and anxiolytic effect useful in managing conditions characterized by hyperexcitation.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Urbanil?

Urbanil (clobazam) is a central nervous system depressant, and its documented safety profile reflects this pharmacological class. All listed adverse reactions and safety considerations are derived strictly from official government regulatory sources, such as the FDA-approved labeling and the European Summary of Product Characteristics (SmPC).

Officially Documented Adverse Reactions and Frequency

The incidence of side effects is classified according to standard regulatory conventions. Effects on the central nervous system are frequently observed:

  • Very Common Reactions (≥ 1/10): Sedation, somnolence (drowsiness), and ataxia (loss of full control of bodily movements) are the most frequent effects documented in official labeling.
  • Common Reactions (≥ 1/100 to < 1/10): This category includes psychiatric effects such as confusion, irritability, aggression, and mood or behavioral changes. Other common effects include dizziness, tremor, and constipation.

Adverse effects are documented across several System-Organ Classes, including Nervous System Disorders, Psychiatric Disorders, Gastrointestinal Disorders, and General Disorders (e.g., fatigue).

Serious Adverse Reactions and Safety Considerations

Regulatory documents highlight the potential for certain effects to become severe, requiring careful consideration:

  • Serious Adverse Reactions: Documented serious risks include respiratory depression (severely slowed breathing), especially when combined with other CNS depressants. Rare but severe and potentially life-threatening cutaneous reactions, such as Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN), are also noted.
  • Duration-Related and Population-Specific Notes: Initial sedative effects are often more frequent at the start of treatment. Risks of dependence and withdrawal syndrome are characteristically associated with long-term use. Furthermore, effects like sedation and ataxia are often more pronounced in older adults, and the medicine is contraindicated in individuals with severe hepatic impairment.

Overdose and Emergency Response

Urbanil overdose presentations are principally defined by escalating Central Nervous System (CNS) depression. Initial manifestations typically include drowsiness, confusion, lethargy, slurred speech (dysarthria), and ataxia (uncoordinated movement). Due to the drug’s pharmacological classification, the risk profile extends to severe physiological compromise. Life-threatening outcomes include respiratory depression, profound hypotension, and the progression to coma. The risk of death is significantly heightened when Clobazam is consumed concurrently with other depressants, such as alcohol or opioids, as documented in official prescribing information.

Immediate medical action is required for any suspected overdose. Emergency services or a Poison Control Centre must be contacted at once, even if the individual appears initially asymptomatic. Urgent medical attention is mandatory for serious signs, including trouble breathing, extreme sleepiness, low blood pressure, or unresponsiveness. Overdose management is symptomatic and supportive, focusing on maintaining adequate ventilation and monitoring vital signs. While the specific antagonist Flumazenil is available, its use in this context is often restricted. Officially documented susceptible populations, such as older adults and patients with impaired renal or hepatic function, may experience heightened sensitivity to these effects.

Therapeutic Uses of Urbanil

What Urbanil Treats: Main Uses and Benefits

Urbanil (clobazam) is generally applied in clinical settings that involve acute or unstable symptom patterns, specifically addressing two core therapeutic domains. It is relevant across domains where additional symptomatic support is needed for both chronic seizure disorders and acute anxiety.


Adjunctive Management of Refractory Epilepsy Syndromes

Urbanil is commonly used to help manage refractory and complex seizure disorders that are resistant to other treatments, such as those associated with Lennox-Gastaut syndrome (LGS). It may be part of symptomatic management in polytherapy for symptoms of increased neurological activity, including specific seizure clusters like tonic and atonic (drop) attacks. The therapeutic benefit plays a role in managing symptoms by easing the overall symptom load, which supports patients during episodes of heightened discomfort.

“This medication is considered relevant in contexts involving heightened systemic burden, where the aim is to ease symptom manifestations.”

Short-Term Relief for Severe Symptomatic Anxiety

This medication is also applicable in situations involving certain distressing symptoms, applied across domains where additional symptomatic support is needed for severe psychological tension. Relevant conditions include situations involving recurrent or episodic manifestations of anxiety where symptoms escalate temporarily, and short-term symptomatic assistance is needed. By helping to ease symptom clusters that may become intense or disruptive, the medication contributes to easing the overall symptom load during periods of heightened symptoms.


Quick Fact: Symptomatic Support for Refractory Seizures

Regulatory References

  1. Australian Therapeutic Goods Administration Product Information

Eligibility and Restrictions for Use

Urbanil (clobazam) eligibility is strictly defined by government regulatory labeling, outlining specific populations that must not use the medicine and others that require restricted use.

Contraindicated Populations

The medicine is contraindicated (absolutely prohibited) for use in patients with a history of hypersensitivity to clobazam or its ingredients. Additionally, the label prohibits use in individuals with severe hepatic insufficiency, myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, and any history of drug or alcohol dependence.


Age and Condition-Based Restrictions

Population Group Eligibility Status (Official Labeling)
Pediatric Use Approved for patients 2 years of age and older. Safety and effectiveness are not established in children under 2 years.
Older Adults Use is permitted, but requires caution due to higher expected plasma concentrations.
Hepatic Impairment Mild to moderate impairment requires a restricted use protocol. Use in severe impairment is contraindicated.
Renal Impairment Mild to moderate impairment requires no adjustment. Use is not established in severe renal impairment or End Stage Renal Disease (ESRD).
Pregnancy Use is conditional: only if the potential benefit justifies the potential risk to the fetus.
Lactation Conditional use; benefits must be weighed against potential risks to the breastfed infant.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Urbanil (Clobazam) describes clinically significant interactions across both pharmacodynamic (PD) and pharmacokinetic (PK) domains, emphasizing central nervous system (CNS) effects and metabolic pathways.

Pharmacodynamic Reinforcement (CNS Depressants)

Co-administration with Opioids carries a formal risk of profound sedation, respiratory depression, coma, and death due to an additive CNS depressant effect, as noted in regulatory warnings. The effects of other CNS depressants, including antipsychotics, hypnotic agents, and muscle relaxants, may also be enhanced.

Pharmacokinetic Interactions (Metabolic)

Clobazam is metabolised by CYP enzymes, and its active metabolite, N-desmethylclobazam (N-CLB), is highly dependent on CYP2C19. Co-administration with strong or moderate CYP2C19 inhibitors (e.g., Fluconazole, Stiripentol) results in increased exposure to N-CLB. Clobazam is also a weak inhibitor of CYP2D6, which may require monitoring when co-administered with CYP2D6 substrates.

Substance and Population Cautions

Alcohol (Ethanol) is documented to increase Clobazam blood levels by approximately mathbf50% and enhances central depressive effects. A specific interaction is also documented with Cannabidiol (CBD), which leads to elevated levels of N-CLB. Specific interaction considerations apply to CYP2C19 Poor Metabolizers and patients with mild to moderate hepatic impairment, who may experience increased exposure to the active metabolite.

Mechanism of Action

Positive Allosteric Potentiation of CNS Inhibition

Urbanil acts as a Positive Allosteric Modulator (PAM) by enhancing the function of the brain's main inhibitory chemical, GABA, at the GABA A receptor complex. This molecular interaction occurs primarily at the allosteric site located between the alpha and gamma subunits, increasing the frequency of the receptor's chloride ion channel opening. This leads to a greater influx of negative chloride ions ( Cl^-) and subsequent neuronal hyperpolarization. This fundamental cellular stabilization limits the generation of excessive or abnormal electrical signaling within the central nervous system.


Mechanism of Sustained Dual-Agent Activity

The total pharmacodynamic activity is sustained by two distinct components: the parent compound, Clobazam, and its primary metabolite, N-desmethylclobazam (Norclobazam). The metabolite is also pharmacodynamically active, functioning as a PAM at the GABA A receptor with similar properties to the parent drug. Since N-desmethylclobazam remains in the system for a prolonged period, it ensures continuous, high-level potentiation of the GABAergic system, which contributes to the prolonged inhibitory physiological effect.


Functional Constraints on Long-Term Response

The GABA A receptor mechanism is subject to potential pharmacodynamic tolerance, an adaptive change that can constrain the magnitude of the mechanism's sustained action. Chronic high-level modulation can cause the nervous system to alter the receptor's structure or sensitivity. This constraint means the capacity for neuronal hyperpolarization may be attenuated under conditions of continuous modulation.

Dosage and Administration Information

Urbanil (Clobazam) is administered exclusively via the oral route, available in multiple forms including tablets, a liquid suspension, and an oral film. The standard usage protocol is defined by a slow, systematic titration process rather than immediate full-dose administration.


Dosing Schedules and Frequency

The medicine is initiated at a low dose, such as 10 mg/day for adults in adjunctive therapy, or 5 mg/day for specific patient groups like older adults or children weighing less than 30 kg. The dose is then increased gradually, with adjustments occurring no more frequently than once every seven days.

For total daily doses exceeding 5 mg, Urbanil is administered in two divided doses (e.g., morning and evening). A total daily dose of 5 mg may be taken as a single dose, often at bedtime. The maximum recommended dose varies by indication and region, typically ranging from 40 mg/day to 60 mg/day.


Administration Conditions and Duration

Urbanil can be taken with or without food. Tablets may be swallowed whole, broken, or, if necessary, crushed and mixed with applesauce before ingestion. The oral film requires placement on the tongue to dissolve completely.

When used for chronic conditions, treatment is typically long-term under medical supervision. Conversely, usage for severe symptomatic anxiety is generally limited to the shortest possible duration, often not exceeding four weeks. Treatment must not be stopped suddenly; the dose requires a gradual reduction (tapering) over several weeks to align with established discontinuation protocols.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Urbanil (Clobazam)

Evidence for Use in Lennox-Gastaut Syndrome (LGS)

Research for Urbanil (Clobazam) primarily originates from controlled clinical trials that examined its use as an add-on treatment for Lennox-Gastaut Syndrome (LGS). LGS is a form of epilepsy characterized by conditions involving periods of heightened symptoms, specifically frequent seizures known as drop attacks (atonic and tonic seizures). Research was structured as short-term, randomized, double-blind, placebo-controlled trials (RCTs), which are used in research exploring how symptoms change over time in patients whose seizures were treatment-resistant and who were already taking other seizure medications.

The research examined several core outcomes related to systemic or functional imbalance and daily functioning. Primary analyses monitored the weekly frequency of drop seizures and measured the percentage of participants achieving pre-defined thresholds of reduction in seizure frequency. Findings describe patterns observed in the studies, highlighting changes measured during the study period. Official reviews of the evidence note the availability of well-designed, randomized, placebo-controlled trials that support the LGS indication. This research provides context regarding the patterns observed in group settings, but not individual predictions for symptom outcomes.

Research Base for Anxiety Symptom Relief

Urbanil was also studied for conditions characterized by fluctuating or episodic manifestations of anxiety. The evidence for this use primarily originates from older clinical studies, including comparative and controlled trials conducted decades ago that examined the medication against other treatments or a placebo. Research explored short-term symptom changes, with studies observing responses over defined time intervals, typically lasting only a few weeks. These supporting studies are considered to have a moderate to low level of certainty based on trial design compared to modern requirements.

Consistency, Strength, and Remaining Uncertainty

Official reviews of the evidence note the availability of well-designed, randomized, placebo-controlled trials that support the LGS indication. Key limitations in the overall evidence landscape include the fact that comparative evidence is lacking, as Urbanil was mostly studied as an add-on to existing treatments, and comparative evidence against other anti-epileptic drugs is limited. Furthermore, follow-up durations were limited in the most rigorous studies, meaning long-term outcomes are not fully established.

Frequently Asked Questions (FAQ)

Common questions about Urbanil (FAQ)


Q: What is Urbanil used for, in simple terms?

A: Urbanil is a medication that works by enhancing the brain's natural calming system to stabilize overactive nerves. Its general purpose, as described in official documentation, is to provide an anticonvulsant (anti-seizure) and anxiolytic (anti-anxiety) effect by influencing the central nervous system.


Q: Is Urbanil the same kind of medicine as similar medicines? What's the main difference?

A: Urbanil is part of the benzodiazepine class of drugs, which are central nervous system depressants. Official sources note that it is chemically classified as a 1,5-benzodiazepine, a structural feature that gives it a distinct profile compared to other commonly known benzodiazepines.


Q: How long does it typically take for Urbanil to start working?

A: Based on regulatory information, the medicine generally begins to take effect within a range of 30 minutes to 4 hours after being taken. The overall effect is sustained over a long period due to the ongoing activity of both the drug itself and its primary active compound in the body.


Q: Does Urbanil cause weight gain or weight loss?

A: Official clinical studies indicate that weight gain is not listed as a frequently observed side effect. However, an increase in appetite was reported in some patients during trials, which is an effect that could potentially lead to changes in weight.


Q: Are there common side effects of Urbanil that usually go away?

A: Official product information notes that the initial sedative effects, such as sleepiness or drowsiness, are generally described as more frequent at the start of treatment. This suggests that these specific reactions may lessen or become less frequent as the body adjusts to the medicine.


Q: Can Urbanil affect how other over-the-counter pain relievers work?

A: Regulatory guidance indicates that Urbanil has the potential to interact with a wide range of other drugs, including over-the-counter medicines and various supplements. Any co-administration, even with pain relievers, should be reviewed by a healthcare provider.


Q: Is Urbanil a type of narcotic or controlled substance?

A: Urbanil (Clobazam) is officially classified as a Schedule IV controlled substance by regulatory bodies in the United States. This classification indicates that the medicine carries a documented potential for abuse or dependence and must be handled carefully.


Q: Does Urbanil cause any known long-term side effects?

A: Regulatory documents state that the risks of developing physical dependence and experiencing withdrawal syndrome are characteristically associated with using the medicine for long periods. These are important considerations for continuous therapy.


Q: Why do some people say they take Urbanil 'as needed'?

A: While the medicine is generally prescribed as a long-term, daily therapy for certain chronic conditions, official research also indicates it may be useful in intermittent use for specific circumstances. This intermittent approach may be discussed for managing things like clusters of seizures or periods of symptom exacerbation.


Q: Is it true that Urbanil can interact with herbal supplements?

A: Regulatory guidance suggests that a broad range of substances, including various herbal products, can potentially alter how Urbanil works in the body. Patients are advised to review all products taken, including supplements, with a healthcare professional to check for potential interactions.


Q: Is there a generic version of Urbanil available?

A: Official regulatory bodies, such as the U.S. FDA, have approved generic formulations of Urbanil (Clobazam). This includes both the tablet and the oral suspension forms of the medicine.


Q: Are headaches a common side effect of Urbanil?

A: While headache has been reported as a side effect, official summaries of clinical trials do not typically list it among the most frequently observed adverse reactions. It is generally described as a less common symptom.


Q: Does Urbanil interact with birth control pills?

A: Yes, official documentation states that Urbanil may reduce the effectiveness of hormonal birth control methods, including pills, patches, or rings. Regulatory guidance describes the need for discussion with a provider regarding the choice of contraception method during treatment.


Q: Can Urbanil affect my ability to drive or operate machinery?

A: Due to the common potential for effects such as sedation, drowsiness, and impaired coordination (ataxia), official guidance advises caution. Due to the documented potential for impairment, official guidance notes that driving or operating hazardous machinery should be avoided until a person is aware of how the medicine impacts their abilities.


Q: What should I do if I feel like Urbanil isn't working for me anymore?

A: The official mechanism of action is subject to pharmacodynamic tolerance, an expected biological process where the body adapts to the medicine over time. This adaptive change can limit the long-term effectiveness of the drug's sustained action during continuous use.


Q: Is Urbanil considered a 'new' drug or has it been around for a while?

A: Urbanil (Clobazam) has been available internationally since the 1970s, where it was studied for both anxiolytic and anti-epileptic purposes. Although its approval for specific indications in certain regions, such as the U.S., occurred more recently, the compound itself is not new.


Q: Why is Urbanil sometimes described as a 'first-line' treatment?

A: Official guidance and treatment guidelines primarily recommend Urbanil as an adjunctive therapy, meaning it is used as an add-on to existing medication. It is generally not listed as a first-line (initial) treatment for conditions like epilepsy.


Q: Does Urbanil interact with common blood pressure medications?

A: Official regulatory documents indicate that Urbanil can have additive effects with certain blood pressure medications, specifically those in the beta-blocker class. This combination can potentially lower blood pressure further and increase the risk of side effects like dizziness or fainting.


Q: What does 'contraindicated' mean when the label mentions certain conditions?

A: The term 'contraindicated' in drug labeling is a strict regulatory warning meaning that use of the medicine is absolutely prohibited for patients who have certain conditions or characteristics. This prohibition exists because the known risks of using the drug in that circumstance are judged to outweigh any potential benefit.


Q: How does the body get rid of Urbanil after I stop taking it?

A: Official pharmacokinetic information indicates that Urbanil is primarily broken down in the liver into a long-lasting, active metabolite. Both the original drug and this active compound are then largely eliminated from the body through the urine over an extended period.


Q: How long does the effect of a single dose of Urbanil typically last?

A: Official pharmacokinetic information indicates that the medicine and its active compounds remain in the body for an extended period, which supports the drug's long duration of action. This is a key feature of the drug's profile.


Q: Does Urbanil have a boxed warning? What is it about?

A: Yes, official U.S. labeling includes an FDA Boxed Warning. This warning covers the risks of using the medicine simultaneously with opioid drugs (due to the potential for severe sedation and breathing issues), as well as the risks of abuse, misuse, addiction, and physical dependence/withdrawal.


Q: Can Urbanil cause stomach problems or nausea?

A: Clinical trial summaries list various gastrointestinal effects. Constipation is a common reaction, and vomiting is also reported in a portion of patients. While nausea is sometimes reported, it is not generally listed as a common adverse reaction.


Q: Do researchers know exactly how Urbanil works in the body?

A: Yes, the mechanism is officially described: Urbanil works by acting as a positive allosteric modulator at the GABA A receptor complex. In simple terms, this action enhances the brain's natural calming effect to reduce abnormal neuronal activity.


Q: Is it important to take Urbanil at the exact same time every day?

A: Official dosing guidelines describe specific patterns, such as taking the medicine in two divided doses (morning and evening) or a single dose at bedtime. While consistency is important for maintaining stable drug levels, the strict necessity of taking it at the exact same minute is not explicitly detailed in the general regulatory instructions.


Q: Does Urbanil affect sleep patterns?

A: The medicine commonly causes somnolence (drowsiness) and sedation. While these effects are documented, official product information does not explicitly describe long-term impacts on the underlying structure or quality of a person’s sleep patterns beyond the sedative effects.

How should Urbanil be stored and disposed of?

How to Store and Dispose of Urbanil (Clobazam)

Official labeling requires Urbanil (clobazam) to be stored at Controlled Room Temperature, typically between 20 C to 25 C (68 F to 77 F). The medication must be protected from freezing, excessive heat, moisture, and light. All forms must be kept in a closed container.

Stability and Handling

For the oral suspension, a stability constraint applies: the product must be discarded 90 days after the bottle is first opened. All medicine must be stored out of the sight and reach of children and kept in a safe place, which is a required handling practice for controlled substances.

Disposal Rules

Regulatory instructions prohibit discarding unused or expired Urbanil via wastewater or household waste. Patients must consult a pharmacist or healthcare professional for guidance on proper disposal to ensure compliance with local and environmental regulations.

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

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