Clobazam

(Onfi®)

Onfi®

Drug updated on 9/4/2024

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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  • Onfi (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Cannabidiol (CBD) showed significant effectiveness in reducing seizure frequency in patients with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC), with enhanced efficacy when used in combination with clobazam.
  • High-dose clobazam (CLB_H) was significantly associated with a ≥50% reduction in drop seizure frequency and had the highest efficacy ranking among antiepileptic drugs (AEDs) in both short-term and long-term outcomes.
  • Clobazam did not demonstrate significant differences compared to other AEDs in overall seizure cessation or reduction according to high-certainty evidence.
  • Common adverse drug reactions (ADRs) included nervous system disorders, severe skin reactions, respiratory infections, and one death due to aspiration pneumonia. Significant concerns included severe skin reactions, respiratory infections/inflammations, central sedation, and interactions with CYP3A4 or CYP2C19 inhibitors.
  • High-certainty evidence indicated a high rate of adverse events leading to study discontinuation with add-on clobazam and other ASMs.
  • Patients on clobazam in combination with CBD experienced increased incidences of somnolence, sedation, and elevated transaminases.
  • Clobazam was associated with adverse events such as drowsiness, and there was a slightly higher incidence of treatment discontinuation due to adverse events.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines