Last reviewed 2026-04-20 · How we verify

Onfi (CLOBAZAM)

Onfi works by enhancing the activity of the neurotransmitter GABA, which helps calm excessive electrical activity in the brain.

Onfi (CLOBAZAM) is a benzodiazepine medication developed by Lundbeck LLC, targeting the GABA-A receptor alpha-1/beta-2/gamma-2 subunits. It is a small molecule modality, approved by the FDA in 2011 for the treatment of Lennox-Gastaut syndrome. Onfi is now off-patent with 22 generic manufacturers available. As a benzodiaziazepine, it carries key safety considerations, including potential for dependence and abuse. Commercially, Onfi is available as a generic medication.

At a glance

Mechanism of action

The exact mechanism of action for clobazam, 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.

Approved indications

• Lennox-Gastaut syndrome

Boxed warnings

• WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [ see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . The use of benzodiazepines, including clobazam oral suspension, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clobazam oral suspension and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.2 )]. The continued use of benzodiazepines, including clobazam oral suspension, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clobazam oral suspension after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clobazam oral suspension or reduce the dosage [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS ; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation ( 5.1 , 7.1 ). The use of benzodiazepines, including clobazam oral suspension, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing clobazam oral suspension and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( 5.2 ). Abrupt discontinuation or rapid dosage reduction of clobazam oral suspension after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clobazam oral suspension or reduce the dosage ( 2.2 , 5.3 ).

Common side effects

• Somnolence or Sedation
• Pyrexia
• Irritability
• Upper respiratory tract infection
• Pneumonia
• Urinary tract infection
• Bronchitis
• Ataxia
• Lethargy
• Dysphagia
• Constipation
• Cough

Drug interactions

• dienestrol
• diethylstilbestrol
• esomeprazole
• estradiol
• estrone
• estropipate
• ethinylestradiol
• fluconazole
• fluvoxamine
• levonorgestrel
• medroxyprogesterone
• norethisterone

Key clinical trials

• Population Pharmacokinetics of Antiepileptic in Pediatrics
• GABA Pathways in Autism Spectrum Disorder (ASD) (NA)
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
• The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children (PHASE4)
• A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (PHASE2)
• An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (PHASE2)
• Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy (NA)
• Use of Clobazam for Epilepsy and Anxiety (PHASE4)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.