temazepam

Trade name: restoril

Small moleculeapproved

Approved

Feb 27, 1981

Temazepam is a benzodiazepine used as a hypnotic agent in the management of insomnia. Temazepam produces CNS depression at limbic, thalamic, and hypothalamic levels of the CNS. Temazepam increases the affinity of the neurotransmitter gamma-aminobutyric acid (GABA) for GABA receptors by binding to benzodiazepine receptors. Results are sedation, hypnosis, skeletal muscle relaxation, anticonvulsant activity, and anxiolytic action. Benzodiazepines bind nonspecifically to benzodiazepine receptors, which affects muscle relaxation, anticonvulsant activity, motor coordination, and memory. As benzodiazepine receptors are thought to be coupled to gamma-aminobutyric acid-A (GABAA) receptors, this enhances the effects of GABA by increasing GABA affinity for the GABA receptor. Binding of the inhibitory neurotransmitter GABA to the site opens the chloride channel, resulting in a hyperpolarized cell membrane that prevents further excitation of the cell. Temazepam is used for the short-term treatment of insomnia (generally 7-10 days). — NCATS

Clinical trial activity

6 trials · 7 clinical orgs · 17 marketing orgs

Phase 1
1
Phase 2
2
Phase 3
2
Phase 4
2

Earliest trial started Oct 1, 2005 (NCT00245661)

Timeline

1980s

  1. Feb 27, 1981

    American Home Products — Earliest FDA Approval

  2. Feb 27, 1981

    Specgx Llc — NDA Secondary Org

  3. Feb 27, 1981

    American Home Products — NDA Organization

  4. Jul 10, 1986

    Mylan — Marketing Organization

  5. Jul 10, 1986

    Sun Pharmaceuticals — Marketing Organization

  6. Jul 10, 1986

    Aurobindo Pharma — Marketing Organization

  7. Apr 21, 1987

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  8. Aug 7, 1987

    Actavis — Marketing Organization

  9. Jan 12, 1988

    Sandoz — Marketing Organization

  10. Jan 12, 1988

    Chartwell Pharmaceuticals — Marketing Organization

  11. Sep 29, 1988

    Duramed Research — Marketing Organization

1990s

  1. May 21, 1993

    Watson Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jun 4, 2015

    Prinston Inc — Marketing Organization

  2. May 23, 2016

    Amneal Pharmaceuticals — Marketing Organization

  3. Nov 23, 2018

    Alembic — Marketing Organization

2020s

  1. Aug 24, 2023

    Alkem Labs Ltd — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedFeb 27, 1981

Chemistry & pharmacology

Loading structure…

SMILES

CN1C2=CC=C(Cl)C=C2C(=NC(O)C1=O)C3=CC=CC=C3
Mol. weight
300.74 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • kentepam
  • levanxene
  • levanxol
  • normison
  • normison
  • restoril
  • restoril
  • restoril
  • (rs)-temazepam
  • temaz
  • temaz
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • temazepam
  • wy-3917
  • wy-3917

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02374567Phase 3Jan 1, 2015Gottfried Wilhelm Leibniz Universität Hannover
NCT01519544N/AMar 1, 2012Harvard University
NCT02153788Phase 4Sep 1, 2009Duke University
NCT00940550Phase 1Jul 1, 2009Lundbeck, University of London
NCT00465972Phase 4Mar 1, 2007Duke University
NCT00245661Phase 3Oct 1, 2005Radboud University, Rijnstate Hospital
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Duke UniversityAcademic/Hospital2212007
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112015
Harvard UniversityAcademic/Hospital1112012
LundbeckFor profit1012009
Radboud UniversityAcademic/Hospital1012005
Rijnstate HospitalAcademic/Hospital1112005
University of LondonAcademic/Hospital1112009
7 organizations
Page 1 / 1

Marketing (18)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGAug 7, 1987
AlembicFor profitMKTGNov 23, 2018
AlembicFor profitSYNNov 23, 2018
Alkem Labs LtdFor profitMKTGAug 24, 2023
American Home ProductsFor profitNDAFeb 27, 1981
Amneal PharmaceuticalsFor profitMKTGMay 23, 2016
Aurobindo PharmaFor profitMKTGJul 10, 1986
Chartwell PharmaceuticalsFor profitMKTGJan 12, 1988
Duramed ResearchFor profitMKTGSep 29, 1988
MylanFor profitMKTGJul 10, 1986
Novel Anti-Infective Technologies, LLCFor profitMKTGApr 21, 1987
Prinston IncFor profitMKTGJun 4, 2015
Quantum PharmaceuticalFor profitMKTG
SandozFor profitMKTGJan 12, 1988
Specgx LlcFor profitNDA2Feb 27, 1981
Sun PharmaceuticalsFor profitMKTGJul 10, 1986
Upsher-Smith LaboratoriesFor profitMKTG
Watson PharmaceuticalsFor profitMKTGMay 21, 1993