Clobazam

(Onfi®)

Clobazam

Drug updated on 6/11/2024

Dosage FormTablet (oral; 10 mg, 20 mg); suspension (oral; 2.5 mg/mL)
Drug ClassBenzodiazepines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

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Summary
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  • Clobazam (Onfi) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. This medication has shown significant efficacy, particularly at high doses, resulting in a reduction in drop-seizures over the long term.
  • Eight systematic reviews and meta-analyses were analyzed to determine information about Onfi's safety profile and effectiveness. These studies highlighted potential adverse reactions such as severe skin reactions, respiratory infections/inflammations, central sedation, and possible interactions with other antiepileptic drugs.
  • Compared to cannabidiol (CBD), clobazam was found to have fewer adverse events like diarrhea, somnolence, and sedation. However, when used alongside CBD, there was an increased incidence of these side effects.
  • In terms of effectiveness compared to other antiseizure medications including felbamate and lamotrigine for LGS treatment, high-dose clobazam along with CBD were among the most effective options according to a systematic review on comparative effectiveness.
  • A Cochrane review suggested that while add-on lamotrigine showed evidence for overall seizure reduction, it ranked below clobazam, which demonstrated its own effectiveness, especially in focal-onset seizures, despite very low-quality evidence supporting this claim, indicating the need for further research into this area.
  • The population types considered included children aged 2 years old up through adults suffering from LGS, which often starts during childhood. Subgroup considerations focused on comorbidity factors such as the interaction between clobazam with other medications, notably CBD, impacting both therapeutic efficiency and safety profiles, requiring careful consideration based on individual patient needs.

Product Monograph / Prescribing Information

Document TitleYearSource
Onfi (clobazam) Prescribing Information.2024Lundbeck, Deerfield, IL

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines