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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONFI safely and effectively. See full prescribing information for ONFI.
ONFI (clobazam) tablets, for oral use, CIV Initial U.S. Approval: 2011

Proprietary Name: ONFITM
Established Name: Clobazam
Dosage Form: Tablet
Route of Administration: Oral
Pharmacologic Class of Drug: Antiepileptic drug of the benzodiazepine class
Chemical Name: 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4(3H,5H)-dione

ONFI® (clobazam) tablets, for oral use, CIV;  ONFI® (clobazam) oral suspension, CIV

[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Clinical pharmacology

Mechanism of Action
The exact mechanism of action for clobazam, a 1,5-benzodiazepine, is not fully
understood but is thought to involve potentiation of GABAergic
neurotransmission resulting from binding at the benzodiazepine site of the
GABAA receptor.

Indications and usage 

ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older




•Somnolence or Sedation: Monitor for central nervous system (CNS) depression. Risk may be increased with concomitant use of other CNS depressants.

•Withdrawal: Symptoms may occur with rapid dose reduction or discontinuation. Discontinue ONFI gradually.

•Physical and psychological dependence: Patients with a history of substance abuse should be monitored for signs of habituation and dependence.

•Suicidal behavior and ideation: Monitor for suicidal thoughts or behaviors.

Adverse reactions

Adverse reactions that occurred in at least 5% of ONFI-treated patients and more frequently than placebo included somnolence or sedation, drooling, constipation, cough, urinary tract infection, aggression, insomnia, dysarthria, and fatigue.

To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or

Dosage and administration 

•Patients ≤30 kg body weight: initiate therapy at 5 mg daily and titrate as tolerated up to 20 mg daily.
•Patients >30 kg body weight: initiate therapy at 10 mg daily and titrate as tolerated up to 40 mg daily.
•Doses above 5 mg/day should be administered in two divided doses.
•ONFI tablets can be administered whole, or crushed and mixed in applesauce.
•Reduce dose, or discontinue drug, gradually.

Dosage adjustment needed in the following groups:
•Geriatric patients
•Known CYP2C19 poor metabolizers
•Mild or moderate hepatic impairment; no information for severe hepatic impairment

How supplied

Tablet: 10 mg and 20 mg with a functional score
Oral Suspension: 2.5 mg/mL in 120 mL bottles


Package Insert data: 

Manufactured by: Catalent Pharma Solutions, LLC Winchester, KY 40391, U.S.A. For: Lundbeck Inc. Deerfield, IL 60015, U.S.A.
™ Trademark of Lundbeck Inc.
October 2011


National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

ONFI (clobazam) ®