Overview
A benzodiazepine used to treat various seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. The agent has also been indicated for treating panic disorder. The mechanism of action appears to involve the enhancement of gamma-aminobutyric acid receptor responses. Since being first patented in 1960 and then released for sale from Roche in the US in 1975, clonazepam has experienced a storied history in the treatment of the aforementioned medical conditions. Now available as a generic medication, the agent continues to see exceptionally high use as millions of prescriptions are written for the medication internationally every year. Unfortunately, however, like most benzodiazepines, clonazepam use has also been associated with recreational use and drug abuse.
Indication
Clonazepam is indicated as monotherapy or as an adjunct in the treatment of Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. Furthermore, clonazepam may also be of some value in patients with absence spells (petit mal) who have failed to respond to succinimides. Additionally, clonazepam is also indicated for the treatment of panic disorder, with or without agoraphobia, as defined in the DSM-V. Alternatively, some regional prescribing information note that clonazepam is indicated for all clinical forms of epileptic disease and seizures in adults, especially absence seizures (petit mal) including atypical absence; primary or secondarily generalised tonic-clonic (grand mal), tonic or clonic seizures; partial (focal) seizures with elementary or complex symptomatology; various forms of myoclonic seizures, myoclonus and associated abnormal movements. Such regional label data also has clonazepam indicated for most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalized epilepsy or to secondary generalization of partial epilepsy.
Associated Conditions
- Akinetic seizures
- Burning Mouth Syndrome
- Essential Tremor
- Gilles de la Tourette's Syndrome
- Lennox-Gastaut Syndrome
- Mixed manic depressive episode
- Panic Disorder
- Rapid Eye Movement Sleep Disorder
- Restless Legs Syndrome (RLS)
- Tardive Dyskinesia (TD)
- Acute Manic episode
- Myoclonic seizures
- Refractory absence Seizures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/09/24 | Not Applicable | Not yet recruiting | Oxleas NHS Foundation Trust | ||
2024/04/10 | Phase 4 | Completed | Pachankis, Yang I., M.D. | ||
2024/01/22 | Not Applicable | Completed | |||
2023/11/15 | Phase 4 | Recruiting | |||
2023/09/28 | Not Applicable | Recruiting | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | ||
2023/09/15 | Phase 4 | Recruiting | Federal University of Minas Gerais | ||
2021/09/28 | Not Applicable | UNKNOWN | Malmö University | ||
2021/05/13 | Phase 2 | Completed | Wroclaw Medical University | ||
2020/04/28 | Not Applicable | UNKNOWN | |||
2017/12/15 | Phase 1 | Completed | Jules Desmeules |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Contract Pharmacy Services-PA | 67046-918 | ORAL | 1 mg in 1 1 | 9/8/2017 | |
Alembic Pharmaceuticals Inc. | 62332-364 | ORAL | 0.125 mg in 1 1 | 11/9/2022 | |
RPK Pharmaceuticals, Inc. | 53002-7451 | ORAL | 1 mg in 1 1 | 9/18/2020 | |
Rebel Distributors | 21695-261 | ORAL | 1 mg in 1 1 | 9/1/2009 | |
Par Pharmaceutical, Inc. | 49884-307 | ORAL | .25 mg in 1 1 | 1/30/2024 | |
PD-Rx Pharmaceuticals, Inc. | 43063-788 | ORAL | 2 mg in 1 1 | 7/5/2023 | |
ATLANTIC BIOLOGICALS CORP. | 17856-0133 | ORAL | 0.5 mg in 1 1 | 3/26/2020 | |
A-S Medication Solutions | 50090-2823 | ORAL | 0.5 mg in 1 1 | 11/21/2017 | |
PD-Rx Pharmaceuticals, Inc. | 72789-314 | ORAL | 1 mg in 1 1 | 6/14/2023 | |
REMEDYREPACK INC. | 70518-1559 | ORAL | 2 mg in 1 1 | 2/21/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
CLONOTRIL 0.5 TABLET 0.5 mg | SIN06410P | TABLET | 0.5 mg | 7/4/1991 | |
CLONAZEPAM MEVON TABLETS 0.5 MG | SIN17075P | TABLET | 0.500 mg | 9/3/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Clonazepam Injection | 国药准字H20046744 | 化学药品 | 注射剂 | 8/31/2020 | |
Clonazepam Injection | 国药准字H53020918 | 化学药品 | 注射剂 | 8/12/2020 | |
Clonazepam Injection | 国药准字H10900003 | 化学药品 | 注射剂 | 11/9/2020 | |
Clonazepam Injection | 国药准字H20249045 | 化学药品 | 注射剂 | 10/16/2024 | |
Clonazepam Tablets | 国药准字H37020390 | 化学药品 | 片剂 | 10/27/2020 | |
Clonazepam Tablets | 国药准字H34020422 | 化学药品 | 片剂 | 11/30/2022 | |
Clonazepam Tablets | 国药准字H22023311 | 化学药品 | 片剂 | 4/13/2021 | |
Clonazepam Tablets | 国药准字H10930144 | 化学药品 | 片剂 | 7/14/2020 | |
Clonazepam Tablets | 国药准字H43020587 | 化学药品 | 片剂 | 5/6/2020 | |
Clonazepam Tablets | 国药准字H31022079 | 化学药品 | 片剂 | 2/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PAXAM 2 clonazepam 2mg tablet bottle NZ | 371570 | Medicine | A | 7/23/2021 | |
PAXAM 2 clonazepam 2mg tablet bottle | 54847 | Medicine | A | 5/28/1996 | |
RIVOTRIL clonazepam 0.5mg tablet blister pack | 285708 | Pharmaco Australia Ltd | Medicine | A | 5/24/2017 |
PAXAM 0.5 clonazepam 0.5mg tablet bottle NZ | 371875 | Medicine | A | 7/29/2021 | |
RIVOTRIL clonazepam 1mg/1mL injection ampoule with diluent ampoule | 13757 | Pharmaco Australia Ltd | Medicine | A | 8/23/1991 |
PAXAM 0.5 clonazepam 0.5mg tablet bottle | 54846 | Medicine | A | 5/28/1996 | |
RIVOTRIL clonazepam 2.5mg/mL oral liquid bottle | 13758 | Pharmaco Australia Ltd | Medicine | A | 8/23/1991 |
Help Us Improve
Your feedback helps us provide better drug information and insights.