flurazepam

Trade name: dalmane

Small moleculeapproved

Approved

Apr 7, 1970

Flurazepam (known under the brand names Dalmane and Dalmadorm) is a drug which is a benzodiazepine derivative. It is a hypnotic agent which does not appear to decrease dream time as measured by rapid eye movements (REM). Furthermore, it decreases sleep latency and number of awakenings for a consequent increase in total sleep time. Flurazepam binds to an allosteric site on GABA-A receptors. Binding potentiates the action of GABA on GABA-A receptors by opening the chloride channel within the receptor, causing chloride influx and hyperpolarization. Flurazepam is useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Flurazepam can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. — NCATS

Clinical trial activity

2 trials · 2 clinical orgs · 18 marketing orgs

Phase 1
1
Phase 2
1
Phase 3
1
Phase 4
0

Earliest trial started Jan 1, 2015 (NCT02350309)

Timeline

1970s

  1. Apr 7, 1970

    Roche — Earliest FDA Approval

  2. Apr 7, 1970

    Bausch Health Companies — NDA Secondary Org

  3. Apr 7, 1970

    Roche — NDA Organization

1980s

  1. Jun 12, 1985

    Mylan — Marketing Organization

  2. Mar 20, 1986

    Par Pharmaceuticals — Marketing Organization

  3. Mar 20, 1986

    Strides Pharma Science — Marketing Organization

  4. Mar 20, 1986

    Novitium Pharma — Marketing Organization

  5. Aug 4, 1986

    Sun Pharmaceuticals — Marketing Organization

  6. Nov 25, 1986

    Watson Pharmaceuticals — Marketing Organization

  7. Nov 25, 1986

    Heritage Pharma — Marketing Organization

  8. Nov 25, 1986

    Chartwell Pharmaceuticals — Marketing Organization

  9. Dec 8, 1986

    Hikma — Marketing Organization

  10. Jul 9, 1987

    Upsher-Smith Laboratories — Marketing Organization

  11. Jan 7, 1988

    Halsey — Marketing Organization

  12. Aug 4, 1988

    Superpharm — Marketing Organization

1990s

  1. Jul 31, 1991

    Rising Pharmaceuticals — Marketing Organization

  2. Jul 31, 1991

    Aurobindo Pharma — Marketing Organization

2010s

  1. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewApr 7, 1970

Chemistry & pharmacology

Loading structure…

SMILES

CCN(CC)CCN1C(=O)CN=C(c2ccccc2F)c2cc(Cl)ccc21.Cl.Cl
Mol. weight
460.81 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • dalmane
  • dalmane
  • dalmane
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazepam
  • flurazépam
  • flurazépam
  • flurazepam hcl
  • flurazepam hcl
  • flurazepam hcl
  • flurazepam hydrochloride
  • flurazepam hydrochloride
  • flurazepam hydrochloride
  • flurazepam hydrochloride
  • flurazepamum
  • flurazepamum
  • insumin
  • insumin
  • ro-56901
  • ro-56901
  • ro-5-6901
  • ro-5-6901
  • stauroderm

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02350309Phase 1Jan 1, 2015Eisai
NCT02374567Phase 3Jan 1, 2015Gottfried Wilhelm Leibniz Universität Hannover
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
EisaiFor profit1112015
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112015
2 organizations
Page 1 / 1

Marketing (20)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGJul 31, 1991
Bausch Health CompaniesFor profitNDA2Apr 7, 1970
Chartwell PharmaceuticalsFor profitMKTGNov 25, 1986
HalseyFor profitMKTGJan 7, 1988
Heritage PharmaFor profitMKTGNov 25, 1986
HikmaFor profitMKTGDec 8, 1986
HikmaFor profitSYNDec 8, 1986
HikmaFor profitSYNDec 8, 1986
MylanFor profitMKTGJun 12, 1985
Novitium PharmaFor profitMKTGMar 20, 1986
Par PharmaceuticalsFor profitMKTGMar 20, 1986
Puracap PharmaceuticalFor profitMKTG
Rising PharmaceuticalsFor profitMKTGJul 31, 1991
RocheFor profitNDAApr 7, 1970
Strides Pharma ScienceFor profitMKTGMar 20, 1986
Sun PharmaceuticalsFor profitMKTGAug 4, 1986
SuperpharmFor profitMKTGAug 4, 1988
Upsher-Smith LaboratoriesFor profitMKTGJul 9, 1987
Warner ChilcottFor profitMKTG
Watson PharmaceuticalsFor profitMKTGNov 25, 1986