MedPath

Clonazepam

Generic Name
Clonazepam
Brand Names
Clonapam, Klonopin, Rivotril
Drug Type
Small Molecule
Chemical Formula
C15H10ClN3O3
CAS Number
1622-61-3
Unique Ingredient Identifier
5PE9FDE8GB

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
No NMPA approvals found for this drug.

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CLONAZEPAM
sivem pharmaceuticals ulc
02442035
Tablet - Oral
0.5 MG
7/9/2015
SANDOZ CLONAZEPAM
02233982
Tablet - Oral
1 MG
12/2/1997
SANDOZ CLONAZEPAM
02233960
Tablet - Oral
0.5 MG
12/2/1997
CLONAZEPAM
02173352
Tablet - Oral
2 MG
N/A
MYLAN-CLONAZEPAM
Mylan Pharmaceuticals ULC
02230951
Tablet - Oral
2 MG
3/20/1997
CLONAZEPAM
sivem pharmaceuticals ulc
02442051
Tablet - Oral
2 MG
7/9/2015
CLONAPAM
bausch health, canada inc.
02230368
Tablet - Oral
1 MG
1/31/1997
APO-CLONAZEPAM
02177889
Tablet - Oral
0.5 MG
12/31/1995
ZYM-CLONAZEPAM
zymcan pharmaceuticals inc
02303310
Tablet - Oral
0.5 MG
2/26/2009
PMS-CLONAZEPAM
02179660
Tablet - Oral
0.25 MG
12/31/1995

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
RIVOTRIL 1 mg/ ml CONCENTRADO Y DISOLVENTE PARA SOLUCION INYECTABLE
52332
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Psicótropos
Commercialized
RIVOTRIL 2,5 mg/ml GOTAS ORALES EN SOLUCION
52333
GOTAS ORALES EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Commercialized
CLONAZEPAM TZF 0,5 MG COMPRIMIDOS EFG
Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
88731
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Not Commercialized
CLONAZEPAM NEURAXPHARM 1 MG COMPRIMIDOS
Neuraxpharm Spain S.L.
85995
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Commercialized
RIVOTRIL 0,5 mg COMPRIMIDOS
52334
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Commercialized
RIVOTRIL 2 mg COMPRIMIDOS
52401
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Commercialized
CLONAZEPAM BIOMED 2 MG COMPRIMIDOS EFG
Biowise Pharmaceuticals, S.L.
79769
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Commercialized
CLONAZEPAM NEURAXPHARM 0,5 MG COMPRIMIDOS EFG
Neuraxpharm Spain S.L.
85994
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Commercialized
CLONAZEPAM TZF 2 MG COMPRIMIDOS EFG
Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
88732
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración. Psicótropos
Not Commercialized
CLONAZEPAM NEURAXPHARM 2 MG COMPRIMIDOS EFG
Neuraxpharm Spain S.L.
85996
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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