CLONAZEPAM
CLONAZEPAM is indicated for the treatment of Seizure Disorder; Lennox-Gastaut Syndrome; Akinetic Seizures; Myoclonic Seizures; Absence Seizures; Panic Disorder; Agoraphobia.
How CLONAZEPAM Works
Clonazepam exerts its pharmacological effects by enhancing the activity of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the central nervous system. It binds to the benzodiazepine site on the GABA-A receptor complex, which increases the frequency of chloride channel opening in the presence of GABA. This leads to membrane hyperpolarization and a reduction in neuronal excitability, resulting in the drug's anticonvulsant and anxiolytic properties.
Details
- Status
- Prescription
- First Approved
- 1996-09-10
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, TABLET
Companies
CLONAZEPAM Approval History
What CLONAZEPAM Treats
7 indicationsCLONAZEPAM is approved for 7 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Seizure Disorder
- Lennox-Gastaut Syndrome
- Akinetic Seizures
- Myoclonic Seizures
- Absence Seizures
- Panic Disorder
- Agoraphobia
CLONAZEPAM Boxed 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 PREC...
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 ). The use of benzodiazepines, including clonazepam tablets, 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 clonazepam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including clonazepam tablets, 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 clonazepam tablets 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 clonazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).
CLONAZEPAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CLONAZEPAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06133114 | STUDY-22-01296 | Ph 4 | recruiting | Psychopharmacological Treatment of Emotional Distress |
| NCT06357104 | SCI-CT-0001 | Ph 4 | completed | Detoxification From the Lipid Tract |
| NCT02913924 results posted | 7343 U54DA037842-01 | Ph 2 | completed | Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients |
| NCT00810316 | A6131015 | Ph 1 | completed | Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population |
| NCT01870024 LORACLOFT | P110123 2012-003795-39 | Ph 3 | completed | Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus |
| NCT02134366 | EPC-1 | Ph 3 | terminated | Clobazam Use in Epilepsia Partialis Continua - Pilot Study |
| NCT02690844 | 1182108 | Ph 4 | withdrawn | Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome |
| NCT03061136 KGB | YOJ0004ARC | Ph 4 | withdrawn | Clonazepam Effects on Brain Oscillations and Cognition in Schizophrenia |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02312908 | 14172EuiYakAn178 | Ph 2 | completed | Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism |
| NCT01291316 | GABA-SPUM | Ph 1, Ph 2 | completed | GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation |
| NCT01011036 | 152/09 SNF SPUM no.33CM30_124117 | Ph 3 | completed | Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CLONAZEPAM FDA Label Details
Indications & Usage
CLONAZEPAM is indicated for the treatment of Seizure Disorder; Lennox-Gastaut Syndrome; Akinetic Seizures; Myoclonic Seizures; Absence Seizures; Panic Disorder; Agoraphobia.
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...
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KLONOPIN
Full clinical data, patents, trials, and competitive landscape for clonazepam.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.