Small Description (basic): 

Clobazam (KLOH-bah-zam) is the generic name (non-brand name) of the brand-name drug commonly known as Onfi in the United States and Frisium (FRIH-zee-um) elsewhere.  The name or look of the medicine may be different in other countries. 

Clobazam is approved for add-on treatment of seizures in children 2 years old or greater and adults who have seizure types that can be associated with Lennox Gastaut Syndrome (LGS). There are many different types of seizure seen with LGS, listed under "Used to Treat". 

Used to treat: 

How to take and store Clobazam?

How to Take:

The dose of Onfi prescribed and how to increase it may vary with a person's body weight.

- For people who weigh less than 30 kg or 66 pounds, Onfi is usually started at 5 mg per day. Increase as directed to 20 mg each day. 

- For people who weigh more than 30 kg or 66 pounds, the drug is usually started at 10 mg each day. Increase as directed to 40 mg each day. 

Onfi is generally taken twice a day. 

Dose increases are typically made once a week or more slowly rate as it takes 5 to 9 days for the dose to reach a stable state in the body. 

Clobazam tablets should be swallowed whole, followed by at least a half a glass of water. They can also be split in half along the score, or crushed and mixed with applesauce or another soft food. 

It's OK to take clobazam either with food or without food. To give it to small children or others who cannot swallow tablets, you can crush it and mix it with a spoonful of soft food such as applesauce, yogurt, or ice cream.

Do NOT stop taking this drug suddenly. 

Using the Oral Suspension:

If you are taking the Onfi oral suspension, shake the bottle well right before you take each dose.  

Measure your dose of Onfi oral suspension using the bottle adapter and dosing syringes that are given with the suspension. 

How to Store:

Store the tablets at room temperature in a dry place that is out of the reach of children.  

Make sure to replace the cap securely after opening the oral suspension bottle and keep the bottle upright.  

Also, use Onfi oral suspension within 90 days of first opening the bottle.  Throw away any unused Onfi suspension after this time. 

What if I forget?

Ask the doctor or nurse what to do if you forget to take a dose. In general, a forgotten dose should be taken right away. If it is almost time for the next dose, just take one dose, not a double dose, and call the doctor's office for more advice.

Do your best to follow the directions. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you. Or set an alarm on a cellphone to remind you when to take a dose. 

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!

How does Clobazam effect the brain?

How Clobazam works in the brain is not fully known. It's thought to affect neurotransmitters or substances in the brain that affect the way brain cells communicate. It seems to involve or increase activity at GABA receptors on certain brain cells.

How does the body digest Clobazam?

- Clobazam is absorbed quickly into the blood stream. The amount peaks or reaches it's highest level within 30 minutes to 4 hours after a dose is taken. 

- Taking the medication with or without food doesn't affect how it is absorbed into the body. 

- The drug is distributed throughout the body quickly. The majority of the medicine is bound to proteins as it circulates through the bloodstream. 

- Clobazam is metabolized or broken down in the liver to the parent or main drug and breakdown products called metabolite. The parent or main drug (clobazam) provides most of the activity in the brain to decrease or stop seizures.  Yet the main metabolite can also be active in the brain in smaller amounts.  

- Clobazam and it's main metabolite last a long time in the body. The mean half-life (or how long it takes for the body to get rid of half of the drug) for clobazam ranges 36 to 42 hours. The metabolite may last longer in the body, up to 82 hours.

- This long half-life means that it takes a while for the drug to reach a steady amount in the system (up to 2 to 3 weeks) and it should not be stopped suddenly. 

How well does the Clobazam work?

The package insert summarizes information from the major studies used by the FDA to approve this drug. These studes have shown that clobazam can decrease the frequency of seizures in people with refractory or uncontrolled seizures, but does not completely control them. The dose of clobazam used was important. People who were given the recommended higher dose had greater improvement in seizures than people who were given a lower dose of clobazam. 

What are the most common side effects of Clobazam?

The side effects of clobazam are generally mild and usually disappear if the dose is reduced. They may also go away over time as a person gets used to the medicine. The side effects most often reported are:

-Drowsiness

-Dizziness

-Poor coordination

-Drooling

-Restlessness or aggressiveness

What to do

If these problems do not go away within several days, or are really bothersome, call the doctor or prescribing health care professional.Sometimes the doctor can help with these side effects by changing the way the medicine is taken. For example, you may be told to: 

-Reduce the overall amount of clobazam.

-Change the amount taken at certain times, such as taking a higher amount of the clobazam at bedtime to lessen daytime sleepiness.

-Give smaller amounts more often during the day. 

No one should stop taking clobazam or change the amount they take or when they take it without their doctor's or prescriber's advice. 

Be sure to read about the serious side effects so you will be aware of symptoms that might indicate the beginning of a serious reaction to clobazam. These serious problems are very rare but everyone who takes this medicine should at least be aware of them.

People who have just started taking clobazam(or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.

Long-term side effects

Clobazam and other benzodiazepines are the medicines that are most likely to cause psychological dependence. When someone takes a benzodiazepine at a certain dosage for more than 2 to 4 weeks, the body (or specifically, the brain's receptors for the neurotransmitter GABA) becomes accustomed to it. Then if a dose is missed or reduced, a withdrawal process starts, with symptoms such as:

-Anxiety

-Increased heart rate

-Tremor

-Generally feeling unwell

Taking another pill relieves all of these symptoms. A person may then believe that he or she "needs" the medication.Yet, this is a very dangerous cycle, since long-term use can cause long-lasting changes in the brain's GABA receptors that lead to significant problems such as impaired cognition, decreased motivation, and depression. In this setting,  lowering a dose quickly can cause severe symptoms of anxiety, insomnia, and illness, as well as seizures.

Many times, a very gradual lowering of the benzodiazepine (often over many months or years) can lead to a dramatic improvement in attention, concentration, memory, and mood without worsening the seizures, insomnia, or anxiety for which the medication was originally prescribed.

What are the most serious side effects of Clobazam?

Most people who take clobazam have no side effects or mild side effects that go away in a short time with no lasting harm. Serious reactions, such as a drug-related skin rash, have been extremely rare. Call your doctor right away if you notice a rash soon after you start taking clobazam.

Sleepy or poor coordination

Like many other seizure medicines, clobazam makes some people feel sleepy or uncoordinated. If you've just started taking clobazam or have just had your dosage increased, be careful when doing things that could be dangerous until you know how it will affect you. Be especially cautious if you tend to be sensitive to medications or if you are taking another medicine that could make you sleepy.

Changes in mood or thinking

One of the great dangers in using medications like clobazam is the tendency to increase the dose if tolerance develops. To a certain extent, this is necessary, but side effects may be increased more than seizure control. If the dose is increased gradually over a long period, subtle changes in mood (such as irritability, depression, or decreased motivation) or problems such as impaired memory may go unnoticed or be considered natural for that person.

High doses sometimes are prescribed for children and adults, especially those with developmental disabilities. Problems with thinking and behavior may be the result. If the dose has been increased gradually over many months or years, it can be hard to separate the effects of the clobazam (or other benzodiazepines) from the effects of other medications, seizures, and other neurological and psychological disorders.

More frequent seizures

An important concern when people with epilepsy take clobazam or other benzodiazepines is the risk that seizures will become more frequent or more severe if the medicine is lowered or stopped. Withdrawal syndrome usually begins as soon as the patient stops taking the medicine and lasts for 8 to 10 days. The longer the person has been taking clobazam and the higher the dose, the greater the tolerance and therefore the higher the risk of worsening seizure control. Even small, gradual dose reductions can temporarily increase seizure activity, but the long-term decrease in effects like drowsiness and depression often makes the change worthwhile.

Besides increased seizure activity, other symptoms of withdrawal include:

-Drowsiness

-Dizziness

-Poor coordination

-Drooling

-Restlessness or aggressiveness

Tell your doctor if you notice these symptoms when your dosage is being reduced.

Suicidal feelings or thoughts

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.

Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;

  • Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.

Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:

  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Impact of Clobazam on bone health

See package insert.

What else is Clobazam used for?

Some evidence suggests efficacy against photosensitive epilepsy and myoclonic seizures.

Who should not take Clobazam?

See package insert.

Can Clobazam be taken with other medicines?

- Clobazam may interact with hormonal contraceptives or birth control, possibly making them less effective. Women of child-bearing age should talk to their health care providers about the best form of contraception for them. A barrier form of contraception should be used by women on clobazam who are taking hormonal birth control. 

- Clobazam may affect some medications metabolized by certain liver enzymes. 

- Clobazam may also be affected by some other medications that inhibit or affect certain liver enzymes (for example, fluconazole, fluvoxamine, ticlopidine, omeprazole).  The dose of clobazam may need to be adjusted. 

- See the package insert for more information about possible drug interactions. 

- Alcohol may also increase the amount of clobazam in the body by about 50%. 

What are the effects of Clobazam on Children?

See package insert.

If a woman takes Clobazam during pregnancy will it hurt the baby?

See package insert.

What are the effects of Clobazam on Seniors

See package insert.

What are the dose ranges for Clobazam?

Follow your doctor's directions. Call if you have any questions.

Young adults and teenagers are usually advised to start by taking 10 milligrams (1 tablet) per day, at night. After about a week, the doctor may prescribe more tablets to get better control of the seizures. Very few people benefit from taking more than 2 or 3 tablets (20-30 mg) per day, however, and side effects usually become more of a problem at higher doses.

If the seizures nearly always occur during sleep or first thing in the morning, the doctor may advise taking all the tablets at bedtime. If daytime seizures occur, the advice may be to take some twice a day. If the dose cannot be equally divided, take the larger amount at bedtime.

Seniors (over age 65) generally require a lower initial dose and particular caution with any increases.

For children, the starting dose is usually half a tablet (5 mg) per day, or even less for very small children. The dose can be increased every 5 to 7 days until the seizures are controlled or side effects become a problem. Giving more than 1 mg per kilogram(2.2 pounds) of the child's body weight per day seldom improves seizure control, however. This dose would represent 3 tablets (30 mg) for a 66-pound child or 2 tablets (20 mg) for a 44-pound child. These amounts would usually be divided into two doses per day.

Be sure to use only the number of tablets that the doctor prescribes. If you think one or two extra pills were taken, call your doctor for advice. For a larger overdose, call your local poison control center or emergency room right away.

No one should stop taking clobazam or change the amount they take without talking to the doctor first. Stopping any seizure medicine all at once can cause a serious problem called status epilepticus. It's particularly unsafe to stop taking any type of benzodiazepine abruptly. The resulting withdrawal symptoms are likely to be unpleasant or even dangerous.

Special Concerns for Clobazam

See package insert.

Read the package insert of Clobazam

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for ONFI (clobazam) is found at:

https://www.lundbeck.com/upload/us/files/pdf/Products/Onfi_PI_US_EN.pdf

Read About Clobazam studies

Abstracts of articles relevant to this topic are available through http://www.ncbi.nlm.nih.gov/pubmed, a service of the National Library of Medicine:

Here are links to some articles relevant to this subject:

http://www.neurology.org/content/early/2011/09/28/WNL.0b013e318232de76.full

http://onlinelibrary.wiley.com/doi/10.1111/epi.12561/full

http://onlinelibrary.wiley.com/doi/10.1111/epi.12561/full

 

Large Description (adv): 

Clobazam is a benzodiazepine which belongs to the same family of drugs that includes lorazepam (Ativan) ,diazepam (Valium), midazolam (Versed) and clonazepam (Klonopin).  Clobazam is different from the other benzodiazepines because it is utilized for the long-term treatment of epilepsy due to its effectiveness and relatively low tendency to produce sedation.

Indications (adv): 

Clobazam belongs to a class of medications called benzodiazepines (BEN-zo-di-AZ-ah-peens).  The medication is indicated for use in patients as an add- on medication for seizures associated with Lennox- Gastaut syndrome.  Patients must be 2 years of age or older.

Forms (adv): 

Onfi is available in a number of dose sizes.  It should be started slowly in a divided dose twice daily, and it should be done according to body weight.  Serum levels of clobazam and its metabolites require 5-9 days to reach a steady state level. Onfi, produced by Lundbeck, is available in the United States as 10 mg and 20 mg scored tablets, as well as 2.5 mg/mL oral suspension.

Dosing (adv): 

The dose of Onfi depends on patient's weight.  The total daily dose should be divided into 2 daily doses.

For patients at or less than 30 kilograms of body weight, start Onfi at 5 milligrams daily and slowly increase the medication up to 20 milligrams a day as tolerated by the patient.

For patients more than 30 kilograms of body weight, start Onfi at 10 milligrams daily and increase the dose up to 40 milligrams a day as tolerated by the patient.

You need to adjust the dose in older patients, patients who are known to slowly metabolize medications through the liver (known CYP2C19 metabolizers) and individuals with liver disease or problems.

How to take and store Clobazam?

Clobazam tablets should be swallowed whole, followed by at least a half a glass of water.

It's OK to take clobazam either with food or without food. To give it to small children or others who cannot swallow tablets, you can crush it and mix it with a spoonful of soft food such as applesauce, yogurt, or ice cream or use the suspension. 

Store the tablets at room temperature in a dry place that is out of the reach of children.

Using the Oral Suspension:

 Shake the bottle well right before you take each dose.  

Measure your dose of Onfi oral suspension using the bottle adapter and dosing syringes that are given with the suspension. 

Use Onfi oral suspension within 90 days of first opening the bottle.  Throw away any unused Onfi suspension after this time.

Missed Doses

In general, a forgotten dose should be taken right away. If it is almost time for the next dose, just take one dose, not a double dose, and call the doctor's office for more advice.

Do your best to follow the doctor's directions. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures! 

Mechanisms of actions of Clobazam

The mechanism of action for clobazam is not fully understood but is thought to involve what is known as potentiation of GABAergic neurotransmission resulting from binding at a benzodiazepine site at the GABA(A) receptor.

Clinical Pharmacology of Clobazam

- The peak plasma level or the level of the drug in the blood is dose proportional over the dose range of 10-80 mg.

- Clobazam is broken down to a metabolite known as N-desmethylclobazam, which has about a fifth the activity of clobazam.  

- The mean half-life or the amount of time that the drug spends in the system as well as for the main metabolite is 36-42 hours for clobazam itself and 71-82 hours for its main metabolite.  

- The drug is rapidly absorbed after oral administration and it peaks in 30 minutes to 4 hours after single or multiple-dose administration.  It is bioavailable.  Food does not affect absorption.  It can be easily crushed in items such as apple sauce or other foods. 

- Clobazam is lipophilic and distributes rapidly throughout the body.  It has a protein binding of 80-90% for clobazam and 70% for its main metabolites.

- Clobazam is metabolized in the liver.  The major metabolic pathway does involve CYP3A4, and to a lesser extent, CYP2C19 and CYP2B6 isoenzymes.  The main metabolite of the drug is the major circulating metabolite in humans, and at therapeutic doses, plasma concentrations of this can be 3 times higher than its parent compound.  Eleven percent of the drug is excreted in feces and 82% is in the urine.

- There is no apparent difference in the metabolism of clobazam between women and men. 

- There is no significant effect of race on the clearance of clobazam either. 

- Renal impairment has been evaluated and patients with severe renal impairment have not been studied extensively, but it apparently seems to be non-problematic in patients with mild or moderate renal impairment. 

- In liver problems, there is limited data to address how things get affected with this condition; however, one needs to exercise caution with regards to its use in this situation.  There is no specific recommendation from the company as to what should be done with people who have kidney or renal problems.

Efficacy of Clobazam

Clobazam is being marketed in the United States under the trade name of Onfi.  The FDA indication for clobazam is strictly for add-on therapy for treatment of seizures associated with Lennox-Gastaut syndrome in children from age 2 and older. 

- The effectiveness for this drug was established in 2 multi-center control studies done specifically to bring the drug to the U.S. market.  Both studies were similar in terms of the patient populations that were studied.  The first study was a randomized, double-blind, placebo-controlled study that looked at patients who were aged 2 to 54 years with a current or prior diagnosis of Lennox-Gastaut syndrome.  The patients were divided into 2 groups by weight, those who were less than 30 kg and those who were greater than 30 kg, and then they were randomized to 1 of 3 maintenance doses of the medication ( 5 mg- Low, 10 mg Medium and 20 mg High doses).  The primary measure for the study was the percent seizure reduction and weekly frequency of various seizures that typify the syndrome, primarily drop, tonic, or myoclonic seizures over a 4-week baseline to a 12-week period of observation on the medication.

In the low-dose group, there was a 41.2% reduction of total seizures.  In the medium-dose group, there was a 49.4% reduction in seizures, and in the high-dose group, a 68.3% reduction.  The placebo group showed only a 12.1% reduction.  Because this is a drug in the benzodiazepine family, they also looked at the issue of tolerance which is common to this drug group.  Tolerance is defined as whether a drug maintains its effectiveness over time at a given dose. In other benzodiazepines, one often needs to take more of a given drug in order to maintain effectiveness.  There was no significant development of tolerance over a 3-month period of observation.

- In the second major study, also a randomized double-blind comparison study of high- and low-dose Onfi consisting of patients aged 2-25 years with a current or prior diagnosis of Lennox-Gastaut, divided into 2 weight groups and then randomized to either a low target dose of 5 mg or 10 mg depending on whether they weighed more or less than 30 kg.  In the high dose group, the target daily dose of 20 mg for less than 30 kg body weight vs. 40 mg for more than a 30 kg body weight. Results showed a significant reduction in seizure frequency in the high dose compared to the low dose group with a median percent seizure reduction of 93% vs. 29%.  Based on these analyses, the drug was approved.

- In other studies done outside of the US, clobazam has been found to be effective amongst almost all seizure types. However, excitement over these findings has been tempered by the fact that the benefits can often be short-lived.  In one large Canadian clobazam cooperative study, more than 40% of patients with a single seizure type had a 50% or greater reduction in seizure frequency and 60% of patients with multiple seizure types had improvement in at least one type of seizures; however, side effects did occur  with the most common being drowsiness.

Common side effects of Clobazam

The most commonly reported side effect with this drug includes tiredness and sedation. In general, these tend to be dose related with the higher doses resulting in higher reports of adverse effects. 

One needs to be careful about the use of this drug with other depressant drugs or alcohol. 

Because it is a benzodiazepine, abrupt discontinuation should be avoided. This drug needs to be tapered slowly, otherwise withdrawal symptoms can occur. Withdrawal symptoms may include convulsions, hallucinations, behavioral disorder, tremor and anxiety. There is the chance of physical and psychological dependence on this drug. 

Similar to other seizure drugs, there is also the risk of suicidal thought or behaviors in patients who take this drug. 

The most common side effects that led to treatment stoppage in the control trials included lethargy, somnolence, ataxia, aggression, fatigue and insomnia.

Other common side effects include gastrointestinal issues, decreased appetite and issues related to depression or psychiatric problems such as aggression or insomnia.

Serious Side effects of Clobazam

Most people who take clobazam have no side effects or mild side effects that go away in a short time with no lasting harm. Serious reactions, such as a drug-related skin rash, have been extremely rare. Call your doctor right away if you notice a rash soon after you start taking clobazam.

Like many other seizure medicines, clobazam makes some people feel sleepy or uncoordinated. If you've just started taking clobazam or have just had your dosage increased, be careful when doing things that could be dangerous until you know how it will affect you. Be especially cautious if you tend to be sensitive to medications or if you are taking another medicine that could make you sleepy.

One of the great dangers in using medications like clobazam is the tendency to increase the dose as tolerance develops. To a certain extent, this is necessary, but adverse effects may be increased more than seizure control. If the dosage is increased gradually over a long period, subtle changes in personality (such as irritability, depression, or decreased motivation) or problems such as impaired memory may go unnoticed or be considered natural for that person.

High doses sometimes are prescribed for children and adults, especially those with developmental disabilities. Problems with thinking and behavior may be the result. If the dose has been increased gradually over many months or years, it can be hard to separate the effects of the clobazam (or other benzodiazepines) from the effects of other medications, seizures, and other neurological and psychological disorders.

An important concern when people with epilepsy take clobazam or other benzodiazepines is the risk that seizures will become more frequent or more severe if the medicine is reduced or stopped. Withdrawal syndrome usually begins as soon as the patient stops taking the medicine and lasts for 8 to 10 days. The longer the person has been taking clobazam and the higher the dose, the greater the tolerance and therefore the higher the risk of worsening seizure control. Even small, gradual dose reductions can temporarily increase seizure activity, but the long-term decrease in effects like drowsiness and depression often makes the change worthwhile.

Besides increased seizure activity, other symptoms of withdrawal include:

  • drowsiness
  • dizziness
  • poor coordination
  • drooling
  • restlessness or aggressiveness

Tell your doctor if you notice these symptoms when your dosage is being reduced.

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.

Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;

  • Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.

Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:

  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Impact of Clobazam on bone health

See package insert.

Other Uses of Clobazam

Some evidence suggests efficacy against photosensitive epilepsy and myoclonic seizures.

Clobazam Contraindications

See package insert.

Clobazam Interactions with other medications

See package insert.

Clobazam effects on Children

See package insert.

Clobazam and Pregnancy

Onfi or clobazam is a pregnancy Category C drug.  There are no adequate or well controlled studies of Onfi in pregnant women and no adequate developmental toxicity studies of clobazam in animals.  Onfi is excreted in human milk.  The effects of this exposure on infants are unknown.  The drug has not been utilized in children under the age of 2 and therefore caution is needed with addressing this group of individuals.

Clobazam effects on Seniors

See package insert.

Clobazam Dosing and titration

Onfi is available in a number of dose sizes.  It should be started slowly in a divided dose twice daily, and it should be done according to body weight.  Serum levels of clobazam and its metabolites require 5-9 days to reach a steady state level. Clobazam will be available in the United States as a 5 mg, 10 mg and 20 mg tablet for oral administration.  The highest dose was 20 mg for less than 30 kg body weight and 40 mg for greater than 30 kg body weight.

Special Concerns for Clobazam

See package insert.

Clobazam Package insert

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for ONFI (clobazam) is found at:

https://www.lundbeck.com/upload/us/files/pdf/Products/Onfi_PI_US_EN.pdf

Clobazam References for Professionals

Abstracts of articles relevant to this topic are available through http://www.ncbi.nlm.nih.gov/pubmed a service of the National Library of Medicine:

Here are links to some articles relevant to this subject:

Conry JA, Ng YT, Paolicchi JM, et al. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia 2009; 50:1158.
 
Ng YT, Conry JA, Drummond R, et al. Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology 2011; 77:1473.

Shorvon SD, Lowenthal A, Janz D, et al. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group. Epilepsia 2000 Sep;41(9):1179-86. PMID: 10999557.

Ben-Menachem E, Falter U. Efficacy and tolerability of levetiracetam 3000 mg/d in patients with refractory partial seizures: a multicenter, double-blind, responder-selected study evaluating monotherapy. European Levetiracetam Study Group. Epilepsia 2000 Oct;41(10):1276-83. PMID: 11051122.

Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res 2001 Nov;47(1-2):17-25. PMID: 11673017.