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What is Onfi? Understanding This Benzodiazepine Medication

3 min read

First approved by the FDA in 2011, Onfi (clobazam) is a prescription benzodiazepine used as an adjunctive therapy to treat seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. A generic version, clobazam, is also available.

Quick Summary

Onfi (clobazam) is an antiepileptic drug for Lennox-Gastaut syndrome that acts on GABA receptors, has an active metabolite, and requires careful dosing. It carries risks like dependence and serious side effects, especially with abrupt discontinuation.

Key Points

  • Drug Class: Onfi (clobazam) is a benzodiazepine anticonvulsant used to treat seizures.

  • Primary Indication: It is an add-on therapy for Lennox-Gastaut syndrome (LGS) in patients aged 2 years and older.

  • Serious Risks: Onfi carries FDA boxed warnings for abuse, dependence, and severe respiratory depression when combined with opioids.

  • Withdrawal: Abruptly stopping Onfi is dangerous and can cause severe withdrawal symptoms, including status epilepticus.

  • Metabolism: Onfi has an active metabolite, N-desmethylclobazam, which has a longer half-life and contributes to its therapeutic effects.

  • Administration: It comes in tablet and oral suspension forms, and dosage is carefully titrated based on weight and tolerability.

In This Article

Onfi is the brand name for the medication clobazam, classified as a Schedule IV controlled substance due to its potential for abuse and dependence. It is approved for use with other medications to treat seizures related to Lennox-Gastaut syndrome (LGS). Onfi is available in tablet and oral suspension forms, and as an oral film in some regions.

How Onfi Works

As a benzodiazepine, Onfi is believed to work by enhancing the inhibitory effect of gamma-aminobutyric acid (GABA), a neurotransmitter in the brain. By binding to GABA-A receptors, Onfi increases GABA's effect, helping to calm overactive nerves and stabilize brain activity to prevent seizures.

The Role of Its Active Metabolite

Onfi is metabolized into an active form called N-desmethylclobazam. This metabolite has a significantly longer half-life (around 82 hours including the active metabolite) compared to Onfi's half-life of about 18 hours. This means the metabolite contributes to the drug's effects for a longer duration, influencing the time it takes to reach stable levels in the body and the dosage titration process.

Important Safety Information and Warnings

Onfi includes three FDA boxed warnings highlighting serious risks.

FDA Boxed Warnings

  • Concomitant Use with Opioids: Combining Onfi with opioids can lead to severe drowsiness, respiratory depression, coma, and death. This combination should be avoided unless other options are insufficient.
  • Abuse, Misuse, and Addiction: Onfi carries a high risk of abuse and addiction, even at prescribed doses. Misuse of benzodiazepines can result in overdose and death.
  • Dependence and Withdrawal Reactions: Long-term use can cause physical dependence. Suddenly stopping Onfi can cause life-threatening withdrawal symptoms, including increased seizures, hallucinations, and suicidal ideation. Gradual tapering is necessary for discontinuation.

Other Serious Side Effects

  • Serious Skin Reactions: Rare but serious skin reactions like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been linked to Onfi. These reactions are life-threatening and may include rash, blistering, fever, or swelling.
  • Mood Changes and Suicidal Thoughts: As with other antiepileptic drugs, Onfi can increase the risk of suicidal thoughts or behaviors in some individuals. Patients should be monitored for mood or behavioral changes.

Onfi Administration and Dosage

Onfi is generally taken twice daily, with or without food. Tablets can be crushed and mixed with applesauce for easier administration if needed. {Link: Drugs.com https://www.drugs.com/dosage/onfi.html}.

Comparison of Onfi with Other Antiepileptic Drugs

Feature Onfi (clobazam) Banzel (rufinamide) Vimpat (lacosamide)
Drug Class Benzodiazepine anticonvulsant Dibenzazepine anticonvulsant Miscellaneous anticonvulsant
Primary Indication Adjunctive treatment for LGS Adjunctive treatment for LGS Adjunctive treatment for partial-onset seizures
Typical Dose Frequency Twice daily Twice daily Twice daily
Generic Available Yes (clobazam) Yes Yes
Half-life Approximately 82 hours (including active metabolite) Approximately 10 hours Approximately 13 hours
Controlled Substance Schedule IV Not Controlled Schedule V
Common Side Effects Sleepiness, drooling, constipation, aggression Dizziness, fatigue, nausea, headaches Dizziness, memory problems, headaches

Conclusion

Onfi (clobazam) serves as a valuable adjunctive treatment for Lennox-Gastaut syndrome seizures in adults and children. It works by enhancing GABA's inhibitory effects and has a significant, long-acting metabolite. Despite its effectiveness, it carries important risks, including potential for abuse, dependence, and severe withdrawal upon sudden discontinuation. Careful dosing, gradual tapering, and following healthcare provider instructions are essential to optimize benefits and mitigate risks. For more information on medications, consult reliable resources such as {Link: MedlinePlus https://medlineplus.gov/druginfo/meds/a612008.html}.

Frequently Asked Questions

Onfi is primarily used as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.

The generic name for Onfi is clobazam. A generic version is widely available and often less expensive than the brand-name product.

Onfi is a federally controlled substance (CIV) because, as a benzodiazepine, it has the potential for abuse, misuse, addiction, and dependence.

No, you should never stop taking Onfi suddenly. Abrupt discontinuation can lead to severe and life-threatening withdrawal symptoms, including an increase in seizures. The dose must be tapered gradually under a doctor's supervision.

Common side effects include drowsiness, tiredness, drooling, constipation, cough, fever, and aggression. These effects can sometimes improve over time.

The FDA has issued a boxed warning against taking Onfi with opioids, as this combination significantly increases the risk of severe sedation, respiratory depression, coma, and death. Your doctor will only do so if no other options are viable.

Onfi itself is absorbed quickly, but it takes about 7 to 9 days for the parent drug to reach a steady-state level and 2 to 3 weeks for the active metabolite, N-desmethylclobazam, to do the same.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.