FDA Approves Onfi

The U.S. Food and Drug Administration (FDA) has approved Onfi (clobazam), an oral benzodiazepine antiepileptic drug, as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older.

Onfi Medication Guide

Read this Medication Guide before you start taking Onfi and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important information about Onfi

Do not stop taking Onfi without first talking to your healthcare provider.

Stopping Onfi suddenly can cause serious problems.

Onfi can cause serious side effects, including:

1. Onfi can make you sleepy or dizzy, slow your thinking, and make you clumsy which may get better over time.
   • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Onfi affects you.
   • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Onfi until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Onfi may make your sleepiness or dizziness much worse.
2. Onfi can cause withdrawal symptoms.
   • Do not stop taking Onfi all of a sudden without first talking to a healthcare provider. Stopping Onfi suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps.
   • Talk to your healthcare provider about slowly stopping Onfi to avoid withdrawal symptoms.
3. Onfi can be abused and cause dependence.
   • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
   Onfi is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Onfi in a safe place to prevent misuse and abuse. Selling or giving away Onfi may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
   
4. Like other antiepileptic drugs, Onfi may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
   • Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
     • thoughts about suicide or dying
     • attempts to commit suicide
     • new or worse depression
     • new or worse anxiety
     • feeling agitated or restless
     • panic attacks
     • trouble sleeping (insomnia)
     • new or worse irritability
     • acting aggressive, being angry, or violent
     • acting on dangerous impulses
     • an extreme increase in activity and talking (mania)
     • other unusual changes in behavior or mood
   • How can I watch for early symptoms of suicidal thoughts and actions?
     • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
     • Keep all follow-up visits with your healthcare provider as scheduled.