Onfi is a brand-name drug that’s prescribed for Lennox-Gastaut syndrome. The medication is available in the following forms: an oral tablet and an oral suspension. Onfi belongs to the benzodiazepines drug class.

Onfi is FDA approved to treat seizures in adults and children 2 years and older who have a rare type of epilepsy called Lennox-Gastaut syndrome (LGS). For this purpose, Onfi is used with other epilepsy medications.

Drug details

You’ll find key information about Onfi below.

  • Drug class: benzodiazepine
  • Drug forms: oral tablet and oral suspension (a type of liquid mixture)
  • Generic available? yes
  • Prescription required? yes
  • Controlled substance? yes
  • Year of FDA approval: 2011

FDA warning

Onfi has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Onfi precautions” section below.

Onfi is a brand-name drug that contains the active ingredient clobazam. This active ingredient is also available as a generic medication. A generic drug is an exact copy of the active ingredient in a brand-name medication.

The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs. In some cases, the brand-name drug and the generic version may come in different forms and strengths.

Onfi can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Onfi. These lists don’t include all possible side effects.

For more information on the possible side effects of Onfi, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Onfi, you can do so through MedWatch.

Mild side effects

Mild side effects of Onfi can include:*

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Onfi. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Onfi’s prescribing information.

Serious side effects

Serious side effects from Onfi aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects can include:

* For more information on these serious side effects, please see the “Side effect details” section below.

Side effects in children and toddlers

Onfi is approved for use in children ages 2 years and older. Side effects in children are expected to be similar to those in adults.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may cause.

Note: In addition to the information above and below, you can refer to this article for details about Onfi’s side effects.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Onfi. It’s unknown how many people have had this side effect with the medication.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction, such as drug reaction with eosinophilia and systemic symptoms (DRESS), is rare but possible. This can be life threatening. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing
  • problems with your liver, kidney, blood, or heart

Call your doctor right away if you develop any symptoms of an allergic reaction. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Weight gain

Weight gain isn’t a direct side effect of Onfi. However, the drug can cause increased appetite in some people, which could lead to weight gain.

If you’re concerned about an increase in your appetite while using Onfi, talk with your doctor. They can help review your diet and exercise habits.

Depression and suicidal thoughts or behaviors

Like other medications used for treating epilepsy, Onfi can cause depression and suicidal thoughts or behaviors. These rare but serious symptoms were seen as soon as 1 week after people started taking Onfi, and continued throughout the treatment.

When starting Onfi treatment, pay close attention to your feelings, thoughts, moods, and behaviors. You’ll want to be on the lookout for any changes, especially sudden ones, in your thoughts, moods, and actions. These could be side effects due to Onfi. You could also ask a close friend or family member to watch for any of these changes in you.

Symptoms of depression and suicidal thoughts or behaviors can include:

  • new or worsened anxiety, depression, or irritability (feeling irritable)
  • having thoughts about dying or suicide
  • panic attacks
  • insomnia
  • other unusual changes in your typical mood or behaviors
  • an urge to act on dangerous impulses

If you have any of these symptoms, call your doctor right away. They’ll be able to work with you to determine if these are a result of Onfi or if something else could be causing your symptoms. They can also see whether a different medication may work better for you.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects if it’s safe to do so.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

The Onfi dosage your doctor prescribes will depend on several factors. These include:

  • how well you respond to Onfi
  • your weight and age
  • other medical conditions you may have

With Onfi, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Onfi comes in two forms. One is a tablet that you swallow. The tablet is available in two strengths: 10 milligrams (mg) and 20 mg.

The other form of Onfi is a suspension (a type of mixture in liquid). You use an oral syringe to swallow the medication. The suspension is available in one strength: 2.5 mg per milliliter (mg/mL). It comes in a 120-mL bottle.

Dosage for seizures

If you weigh more than 30 kilograms (about 66 pounds), you’ll start by taking 10 mg of Onfi per day. The dose is divided into two: 5 mg in the morning and 5 mg in the evening.

If 10 mg doesn’t work for you, your doctor may increase your dosage, up to a maximum of 40 mg per day. This would be taken as two separate doses: 20 mg in the morning and 20 mg in the evening. Your doctor will wait at least 7 days before increasing your dose to see how the drug works for you.

Your doctor may give you a different dosage depending on several factors, including your age and whether you have liver disease. If you have questions about the dosage that’s right for you, talk with your doctor.

Pediatric dosage

Onfi is approved for use in children ages 2 years and older. The dosage in children depends on body weight in kilograms (kg), as described below.

Children weighing 30 kg (about 66 lb) or less

For children weighing 30 kilograms (kg), which is about 66 pounds (lb), or less, the starting dosage of Onfi is 5 mg taken once per day.

If the 5-mg dose isn’t effective, your child’s doctor can increase the dosage to a total of 10 mg per day. Your child will take this as two separate doses: 5 mg in the morning and 5 mg in the evening.

If the 10-mg dose still isn’t effective, your child’s doctor can increase the Onfi dosage again to a total of 20 mg a day. Your child will take this as two separate doses: 10 mg in the morning and 10 mg in the evening.

Your child’s doctor will wait at least 7 days before increasing the dosage to see how the drug works for your child.

Children weighing more than 30 kg (about 66 lb)

For children who weigh more than 66 lb, the dosage is the same as that for adults. See “Dosage for seizures” just above.

What if I miss a dose?

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Onfi is meant to be used as a long-term treatment. If you and your doctor determine that Onfi is safe and effective for you, you’ll likely take it long term.

Note: In addition to the information above, you can refer to this article for details about Onfi’s dosage.

The Food and Drug Administration (FDA) approves prescription drugs such as Onfi to treat certain conditions. Onfi may also be prescribed off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Onfi for seizures

Onfi is approved by the FDA to treat seizures in people who have a type of epilepsy called Lennox-Gastaut syndrome (LGS). For treating LGS, Onfi is used as adjunctive therapy. This means you’ll take Onfi in addition to other epilepsy medications.

Onfi is approved for use in adults as well as children ages 2 years and older.

Seizures and LGS explained

Seizures are changes in the electrical activity of your brain. There are several kinds of seizures.

LGS is a rare and severe kind of epilepsy (a condition in which you have seizures repeatedly). LGS often begins in childhood, usually between ages 2 and 6 years. People with LGS can have any type of seizure. The most common include tonic seizures, atonic drop seizures, and generalized tonic-clonic seizures. LGS can also cause trouble learning and developmental delays.

With LGS, cognitive function gets worse with time. Cognitive function includes mental actions such as thinking, memory, and attention.

To learn more, you can refer to our epilepsy and seizures hub.

Effectiveness for seizures

Onfi has been shown to be effective for treating seizures due to LGS.

In one study, people with LGS were randomly assigned to take either Onfi or a placebo (treatment with no active medication). The researchers tracked the number of seizures the people had each week during the study, and then compared this to the baseline numbers. After 12 weeks, people who took Onfi had a more significant reduction in their number of seizures per week than people who took a placebo.

Off-label uses for Onfi

In addition to the uses listed above, Onfi may be prescribed off-label for other purposes. Off-label drug use is when a drug is prescribed for a use that it’s not FDA approved for. Below are examples of off-label uses for Onfi.

Onfi for other types of seizures

Onfi is currently FDA approved to treat only seizures due to LGS. However, the drug may be prescribed off-label to treat other types of epilepsy. In countries besides the United States, Onfi is approved for treating different types of seizures than those caused by LGS.

For example, Onfi may be used in adults with drug-refractory epilepsy (DRE). This condition occurs when medications don’t help manage your seizures.

If you have questions about using Onfi for other types of seizures, talk with your doctor.

Onfi for anxiety

The FDA hasn’t approved Onfi to treat anxiety. But the medication is approved for treating acute and chronic anxiety in other countries. (“Acute” means sudden, and “chronic” refers to long term.)

Onfi belongs to a group of medications known as benzodiazepines. Other benzodiazepines are approved to treat anxiety, so it’s thought that Onfi could possibly work to treat anxiety, too.

If you have questions about using Onfi for anxiety, talk with your doctor.

Onfi and children

Onfi is approved for use in adults as well as children ages 2 years and older.

Onfi is approved to treat seizures caused by Lennox-Gastaut syndrome (LGS). For this purpose, Onfi is used as an adjunctive treatment, which means you’ll take the drug with other epilepsy medications. (Onfi is not approved to be used as the only seizure medication in people with LGS.)

Examples of other epilepsy medications that you may take with Onfi include:

You shouldn’t drink alcohol while taking Onfi.

Alcohol and Onfi are both central nervous system (CNS) depressants. CNS depressants slow down the activity of your CNS (brain and spinal cord), and this can cause side effects like drowsiness and excessive sleepiness.

Combining two CNS depressants, such as alcohol and Onfi, can further increase your risk for side effects, including serious ones.

In addition to being a CNS depressant, alcohol can also increase the level of Onfi in your body. This can also increase the number or severity of your side effects.

If you drink alcohol, talk with your doctor about whether it’s safe for you to drink alcohol during Onfi treatment.

Onfi can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

FDA warning: Onfi use with opioids

The Food and Drug Administration (FDA) has issued a boxed warning about using Onfi with opioid medications. A boxed warning is the most severe warning from the FDA.

The use of Onfi with opioids can cause severe side effects. These effects can include sedation (extreme drowsiness or tiredness) and respiratory depression (slow and weak breathing). They can also include coma and, in some cases, death.

Your doctor will prescribe Onfi with an opioid only when no other treatments will work for you. And if you do use Onfi with an opioid, you should take the lowest dose of Onfi that’s effective for you. Your doctor will monitor you for symptoms of sedation and respiratory depression during your Onfi treatment.

Onfi and other medications

Below are some other medications that can interact with Onfi. This section doesn’t contain all drugs that may interact with Onfi.

Before taking Onfi, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Onfi and other drugs that can affect your central nervous system

Onfi is a type of drug called a central nervous system (CNS) depressant. CNS depressants slow down the activity of your CNS (brain and spinal cord), and this can cause side effects like drowsiness and excessive sleepiness.

Combining two CNS depressants can further increase your risk for side effects, including serious ones.

Examples of other CNS depressants include:

It’s not recommended that you take Onfi with another CNS depressant. But if no other treatments will work for your condition, your doctor might prescribe both medications. If this is the case, your doctor will monitor you very closely for any side effects. And they’ll try to keep the doses of your medications as low as possible.

Onfi and certain drugs that affect how your body breaks down Onfi

Taking Onfi with certain medications that affect how your body metabolizes (breaks down) Onfi can change the level of Onfi in your system. This can increase your risk for side effects.

Examples of medications that can affect your body’s level of Onfi include:

Tell your doctor about all the medications you take. They can determine if any will affect how your body breaks down Onfi. If you need to take one of these drugs during your Onfi treatment, your doctor will monitor you closely for side effects. They may also change your dose of Onfi or switch you to a different medication for seizures.

Onfi and hormonal birth control

If you use hormonal contraception (birth control that contains hormones), keep in mind that Onfi may make it less effective. This is because Onfi can speed up how quickly your body processes hormonal contraception. With a lower level of hormonal contraception in your body, you have an increased risk for becoming pregnant.

Examples of hormonal contraceptives include:

  • birth control pills, such as:
    • ethinyl estradiol/drospirenone/levomefolate (Beyaz)
    • ethinyl estradiol/norethindrone acetate (Loestrin)
    • ethinyl estradiol/drospirenone (Yasmin, Yaz)
  • birth control shot:
  • birth control ring:
    • etonogestrel/ethinyl estradiol (NuvaRing)
  • birth control patch:
    • ethinyl estradiol/norelgestromin

Nonhormonal forms of birth control

If you are using a hormonal contraceptive, your doctor may recommend that you switch to a nonhormonal form of birth control while taking Onfi.

Examples of nonhormonal forms of birth control include:

If you have additional questions about birth control while using Onfi, see the “Onfi and birth control” section below and talk with your doctor.

Other IUDs

Certain IUDs contain levonorgestrel, making them a type of hormonal contraception. These include Kyleena, Liletta, Mirena, and Skyla. However, a small study showed that the use of Mirena with epilepsy drugs didn’t affect how well Mirena worked.

If you’re using one of these IUD products, talk with your doctor about your specific birth control needs before taking Onfi.

Onfi and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Onfi. However, you should still check with your doctor or pharmacist before using any of these products while taking Onfi.

Onfi and foods

There aren’t any foods that have been specifically reported to interact with Onfi. If you have any questions about eating certain foods with Onfi, talk with your doctor.

As with all medications, the cost of Onfi can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons: You can visit Optum Perks for price estimates of Onfi. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Financial and insurance assistance: If you need financial support to pay for Onfi, or if you need help understanding your insurance coverage, help is available.

Onfi’s manufacturer offers a copay savings card, a free trial, and other resources. For more information and to find out if you’re eligible for support, call 855-345-6634 or visit the program website.

Generic version: Onfi is available in a generic form called clobazam. A generic drug is an exact copy of the active ingredient in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs. To find out how the cost of clobazam compares to the cost of Onfi, talk with your doctor or pharmacist.

To learn more about saving money on prescriptions, check out this article.

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Other drugs are available that can treat your condition. If you’re interested in finding an alternative to Onfi, talk with your doctor.

Note: Some of the drugs listed here are prescribed off-label to treat this specific condition. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Alternatives for seizures

Examples of other drugs that may be used to treat seizures due to Lennox-Gastaut syndrome (LGS) and are approved for this use include:

Other drugs that may be used to treat seizures due to LGS, but are prescribed off-label for this condition, include:

  • carbamazepine (Tegretol, others)
  • clonazepam (Klonopin)
  • diazepam (Valium)
  • divalproex sodium (Depakote, Depakote ER)
  • ethosuximide (Zarontin)
  • gabapentin (Neurontin)
  • lacosamide (Vimpat)
  • levetiracetam (Keppra)
  • lorazepam (Ativan)
  • oxcarbazepine (Trileptal, Oxtellar XR)
  • perampanel (Fycompa)
  • phenobarbital
  • phenytoin (Dilantin)
  • pregabalin (Lyrica)
  • primidone (Mysoline)
  • tiagabine (Gabitril)
  • valproic acid
  • vigabatrin (Sabril)
  • zonisamide (Zonegran)

You may wonder how Onfi compares with other medications that are prescribed for similar uses. Here we look at how Onfi and Sympazan are alike and different.

Ingredients

Both Onfi and Sympazan contain the active ingredient clobazam. But the medications come in different forms.

Uses

The Food and Drug Administration (FDA) has approved both Onfi* and Sympazan* to treat seizures in people with a type of epilepsy called Lennox-Gastaut syndrome (LGS). For this purpose, both Onfi and Sympazan are used as an adjunctive treatment. This means you’ll take either Onfi or Sympazan with other epilepsy medications.

Both Onfi and Sympazan are approved for use in adults as well as children ages 2 years and older.

* Both Onfi and Sympazan have a boxed warning about risks if they’re used with opioids. A boxed warning is the most serious warning from the FDA. For more information, see “Onfi precautions” below.

Drug forms and administration

Onfi comes in two forms. One is a tablet that you swallow. The other form of Onfi is a suspension (a type of mixture in liquid). You use an oral syringe to swallow the medication in this form.

Sympazan comes as an oral film that you apply to the top of your tongue, where it dissolves and releases the medication.

Side effects and risks

Onfi and Sympazan both contain clobazam. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

This list contains some of the most common mild side effects that can occur with Onfi and Sympazan (when taken individually):

  • constipation
  • feeling unusually sleepy or drowsy
  • feeling more tired or having less energy than usual
  • trouble sleeping
  • acting aggressively or violently, or feeling more angry than usual
  • fever
  • drooling
  • ataxia (trouble controlling or coordinating your muscles)
  • upper respiratory infection
  • vomiting

Serious side effects

This list contains examples of serious side effects that can occur with Onfi and Sympazan (when taken individually).

Effectiveness

These drugs haven’t been directly compared in clinical studies, but studies have found both Onfi and Sympazan to be effective for treating seizures due to LGS, when used with other medications for seizures.

Costs

Costs of Onfi and Sympazan will vary depending on your treatment plan. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Onfi and Sympazan are both brand-name drugs. Onfi is also available as a generic drug called clobazam. This is the active drug ingredient in Onfi. There are currently no generic forms for Sympazan. Brand-name medications usually cost more than generics.

Visit Optum Perks to find coupons and savings for Onfi and Sympazan.

Like Sympazan (above), the drug Banzel has uses similar to those of Onfi. Here’s a comparison of how Onfi and Banzel are alike and different.

Ingredients

Onfi contains the active drug clobazam, which belongs to a group of medications called benzodiazepines.

Banzel contains the active drug rufinamide. The group of medications that rufinamide belongs to is called anticonvulsants.

Uses

The Food and Drug Administration (FDA) has approved both Onfi* and Banzel to treat seizures in people with a type of epilepsy called Lennox-Gastaut syndrome (LGS). For this purpose, both Onfi and Banzel are used as an adjunctive treatment. This means you’ll take either Onfi or Banzel with other epilepsy medications.

The two drugs do differ in who they’re used for. Onfi is approved for use in adults as well as children ages 2 years and older. Banzel is approved for use in adults as well as children ages 1 year and older.

* Onfi has a boxed warning for risks when used with opioids. A boxed warning is the most serious warning from the FDA. For more information, see “Onfi precautions” below.

Drug forms and administration

Both Onfi and Banzel come in two forms. One is a tablet that you swallow. The other form is a suspension (a type of mixture in liquid). You use an oral syringe to swallow the medication in this form.

Side effects and risks

Onfi and Banzel contain different drugs, even though they’re used to treat the same condition. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain some of the most common mild side effects that can occur with Onfi, with Banzel, or with both drugs (when taken individually).

  • Can occur with Onfi:
    • constipation
    • trouble sleeping
    • acting aggressively or violently, or feeling more angry than usual
    • fever
    • drooling
  • Can occur with Banzel:
  • Can occur with both Onfi and Banzel:
    • feeling unusually sleepy or having less energy than usual
    • decreased appetite
    • vomiting
    • upper respiratory infection
    • ataxia (trouble controlling or coordinating your muscles)

Serious side effects

These lists contain examples of serious side effects that can occur with Onfi, with Banzel, or with both drugs (when taken individually).

Effectiveness

These drugs haven’t been directly compared in clinical studies, but studies have found both Onfi and Banzel to be effective for treating seizures due to LGS, when used with other medications for seizures.

Costs

Costs of Onfi and Banzel will vary depending on your treatment plan. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Onfi and Banzel are both brand-name drugs. But Onfi is also available as a generic drug called clobazam. This is the active drug ingredient in Onfi. There are currently no generic forms for Banzel. Brand-name medications usually cost more than generics.

Visit Optum Perks to find coupons and savings for Onfi and Banzel.

You should take Onfi according to your doctor’s or healthcare professional’s instructions.

How to take Onfi tablets

You can swallow Onfi tablets whole or break them along the score line in the middle of the tablet. You can also crush Onfi tablets to mix in applesauce.

How to use Onfi liquid solution

You’ll take the Onfi oral suspension (liquid solution) by swallowing it. It comes with an oral syringe that you’ll use to take your dose. Be sure to shake the bottle before each dose.

It’s very important that you use only this syringe and not a spoon to measure the medication. You shouldn’t use your Onfi syringe for anything other than measuring and taking your dose of the drug.

For a step-by-step guide and photos on how to take the oral suspension, see the manufacturer’s instructions.

When to take Onfi

When you take your Onfi liquid solution will depend on your dose. If your total daily dose of Onfi is more than 5 mg, then you’ll take Onfi twice a day. This will be the case for most people. (See the “Onfi dosage” section above for details.) Taking one dose in the morning and another in the evening tends to work best at helping you remember to take both doses.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Onfi with food

You can take Onfi tablets and the oral suspension with or without food.

Can Onfi tablets be crushed, split, or chewed?

If needed, you can break Onfi along the score line in the middle of the tablet. You can also crush Onfi tablets to mix in applesauce.

Onfi is approved to treat seizures in people with a type of epilepsy known as Lennox-Gastaut Syndrome (LGS). It’s used with other epilepsy medications.

Onfi contains the drug clobazam. It’s not known exactly how Onfi works to reduce the number of seizures people have. During a seizure, abnormal signals are sent from the brain to the rest of the body. It’s thought that Onfi may work on certain pathways in the brain, preventing these signals from being made or sent.

How long does it take to work?

Onfi begins working as soon as you take your dose. But you may not feel the drug working right away. It could take a few days or even 1–2 weeks for Onfi to have its full effect, especially when you first start your treatment. This is because your doctor will likely have you start with a low dose of the drug and work your way up to a higher dose over time.

Onfi may not be safe to take during pregnancy. The use of Onfi later in pregnancy may result in complications in newborns, including breathing and feeding problems. Newborns may also experience withdrawal from the drug because Onfi can cause dependence. (For more about becoming dependent on Onfi, see the “Onfi withdrawal and dependence” section below.)

Animal studies

Currently, there isn’t much data on the use of Onfi during pregnancy. In animal studies, pregnant animals that were given Onfi had babies with a lower body weight and a higher risk of congenital anomalies (commonly known as birth defects). Some pregnant animals that were given high doses of Onfi experienced pregnancy loss.

Keep in mind that animal studies don’t always predict what might happen in humans.

Floppy baby syndrome

A condition called floppy baby syndrome (FBS) wasn’t reported in clinical trials of Onfi. But since Onfi came onto the market, there have been rare reports of FBS in babies whose parent took Onfi while pregnant. FBS is a condition that causes problems with muscle control. It’s not known how often FBS has occurred in pregnant people who took Onfi.

Pregnancy registry

If you’re using Onfi and become pregnant, ask your doctor about the North American Antiepileptic Drug Pregnancy Registry. This program helps collect data on the safety of using epilepsy drugs such as Onfi during pregnancy. You can find out more information by visiting the program website.

If you’re pregnant or are planning to become pregnant, talk with your doctor before using Onfi. They can review the pros and cons of the medication with you.

Onfi may not be safe to use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Onfi.

If you use hormonal contraception (birth control that contains hormones), keep in mind that Onfi may make it less effective. This is because Onfi can speed up how quickly your body processes hormonal contraception. With a lower level of hormonal contraception in your body, you have an increased risk for becoming pregnant.

To learn more about how Onfi affects hormonal contraceptives, see the “Onfi and hormonal birth control” section above.

Onfi may not be safe to use while breastfeeding.

Onfi passes into human breast milk. This can cause side effects in breastfed children, including unusual sleepiness and lack of energy, and a poor ability to suck during feedings. In the short term, these problems aren’t expected to cause harm. But over time, the problems can cause children to be sedated (overly sleepy or lacking in energy) or not gain weight.

If you’re breastfeeding or plan to breastfeed your child, tell your doctor. They can decide if taking Onfi is the best option for you.

Here are answers to some frequently asked questions about Onfi.

Will Onfi cure my seizures?

Currently, there isn’t a cure for seizures, so Onfi won’t cure them. But clinical studies have shown that the drug may help reduce the number of seizures in people with Lennox-Gastaut syndrome (LGS).

If you have more questions about treatment options for seizures, talk with your doctor.

Is Onfi addictive?

Yes, Onfi can be addictive. The drug has boxed warnings about the risk of addiction and misuse. These are the most serious warnings from the Food and Drug Administration (FDA).

When you’re addicted to a drug, you aren’t able to keep from taking the drug on a consistent basis, even though the drug has negative effects on your life. Onfi can be taken for inappropriate uses, like getting high. And misusing Onfi (taking it in a way other than how your doctor prescribes it) can lead to addiction.

See “Onfi precautions” below for details about the drug’s boxed warnings. You can also talk with your doctor or pharmacist.

Is Onfi a controlled substance?

Yes. Onfi is a controlled substance, which is a medication whose use is specially regulated under federal law. The Drug Enforcement Administration (DEA) places substances into “schedules” based on several factors. These factors include the medical uses for the drug, the drug’s known safety risks, and the drug’s potential for misuse. The schedules range from Schedule I (the most severe) to Schedule V (the least severe). Drugs that don’t appear to have a potential for misuse won’t have a schedule at all.

Onfi is a Schedule IV medication. This means that although Onfi has a risk of misuse and causing you to become dependent on it, the risk is lower compared with other controlled substances.

Onfi contains the active drug clobazam, which belongs to a group of medications called benzodiazepines. These medications have a high risk of misuse and addiction. And if you take too much of them, they can also cause dangerous side effects, including coma and, in some cases, death. The use of benzodiazepines with other drugs, including alcohol, can also cause these dangerous side effects.

Onfi has boxed warnings about the risks of misuse, addiction, dependence, and withdrawal. See “Onfi precautions” below for details.

If you have any concerns about using Onfi, talk with your doctor.

Will I have withdrawal symptoms if I stop taking Onfi?

It’s possible to have withdrawal symptoms, especially if you suddenly stop taking Onfi. Instead, Onfi use needs to be tapered off gradually. Your doctor will do this by slowly decreasing your dose over time. You shouldn’t stop taking Onfi without first talking with your doctor.

For more information, see the section “Onfi withdrawal and dependence” below.

Is Onfi the same as Xanax?

No, Onfi isn’t the same as Xanax.

Onfi contains the active drug clobazam. Xanax contains the active drug alprazolam. Both clobazam and alprazolam belong to a group of medications called benzodiazepines.

Although the two drugs belong to the same group of medications, they’re used for different conditions. The Food and Drug Administration (FDA) has approved Onfi to treat seizures in people with LGS, when used with other seizure medications.

Xanax is FDA approved to treat anxiety disorders or for short-term treatment of anxiety symptoms. Xanax is also approved to treat panic disorder. This is a condition in which you’ve had repeated panic attacks of sudden, intense fear and are afraid of having them again.

Can I drive while taking Onfi?

Maybe. Onfi is a type of drug called a central nervous system (CNS) depressant, which can make you drowsy and sleepy. So you should avoid any activity that requires you to be mentally alert until you know how Onfi will affect you. This includes driving a car or using heavy machinery. For more information, see the “Severe drowsiness” section above.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.

Risks if used with opioids: The use of Onfi with opioid medications can cause severe side effects. These effects can include sedation (extreme drowsiness or tiredness) and respiratory depression (slow and weak breathing). They can also include coma and, in some cases, death.

Your doctor will prescribe Onfi with an opioid only if no other treatments will work for you. And if you do use Onfi with an opioid, your doctor will prescribe the lowest dose of Onfi that’s effective for you. They’ll also monitor you for symptoms of sedation and respiratory depression during your Onfi treatment.

Risk of dependence and withdrawal: Using this drug, even as prescribed, can lead to physical dependence and withdrawal if you stop taking the drug suddenly. Withdrawal can be life threatening. See “Onfi withdrawal and dependence” below for details.

Risk of misuse and addiction: Taking this drug can also lead to misuse and addiction. Misusing Onfi (taking it in a way other than how it’s prescribed) increases the risk of overdose and death.

Other precautions

Before taking Onfi, talk with your doctor about your health history. Onfi may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Liver problems: If you have liver problems, your doctor may have you try a lower dose of Onfi to start. For more information, talk with your doctor.
  • Kidney problems: If you have severe kidney problems or are on dialysis, talk with your doctor before using Onfi. They may want you to use a different drug instead.
  • Mood problems, depression, or suicidal thoughts or behaviors: Onfi can increase your risk for mood problems, depression, and suicidal thoughts or behaviors. So if you had or have any of these issues, your doctor will want to monitor you during your Onfi treatment. Talk with them about your mental health before taking Onfi. Your doctor will work with you to determine the best treatments for you.
  • Allergic reaction: If you’ve had an allergic reaction to Onfi or any of its ingredients, your doctor won’t prescribe Onfi for you. Ask your doctor what other medications are better options for you.
  • Pregnancy: Onfi may not be safe to take during pregnancy. For more information, see the “Onfi and pregnancy” section above.
  • Breastfeeding: Onfi may not be safe to take while breastfeeding. For more information, see the “Onfi and breastfeeding” section above.

Note: For more information about the potential negative effects of Onfi, see the “Onfi side effects” section above.

Using more than the recommended dosage of Onfi can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Onfi can be addictive and cause you to become dependent on the drug.

When you’re addicted to a drug, you aren’t able to keep from taking the drug on a consistent basis, even though taking the drug has negative effects on your life. Misusing Onfi can lead to addiction. Misuse refers to taking the drug in a way other than how your doctor prescribes it, such as taking too much.

When you’re physically dependent on a drug, your body has become used to the drug being in your system. Your body requires the drug to feel and function like usual. You can become physically dependent on a drug even when your doctor has prescribed it and you’re using it as directed. If you stop taking the drug, you can experience withdrawal side effects (see the list below).

Withdrawal symptoms

Stopping your Onfi treatment suddenly can cause you to have withdrawal symptoms, which can include:

Because of these possible withdrawal symptoms, it’s very important that you don’t suddenly stop taking Onfi. Instead, your doctor will have you gradually stop taking the drug over time. This is known as “tapering” the drug. Your doctor will slowly decrease your Onfi dose over time until it’s safe for you to stop taking the drug entirely.

If you have any concerns about using Onfi, talk with your doctor.

When you get Onfi from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about how to correctly dispose of it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store both Onfi tablets and the liquid suspension between 68°F and 77°F (20°C and 25°C).

Keep the Onfi liquid suspension in the original bottle, stored upright and tightly closed. You should use it within 90 days of first opening the bottle. After 90 days, dispose of any liquid suspension that’s leftover.

Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Onfi and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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