Drugs / Temazepam
Temazepam
also known as
(rs)-temazepam · Kentepam · Normison · NSC-246303 · Restoril · Temaz · Temazepam civ · WY-3917
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | TEMAZEPAM | — | 2009-06-12 – 2010-05-21 | fda.gov ↗ |
| Label expansion | US (FDA) | RESTORIL | — | 1991-10-25 | fda.gov ↗ |
| Approved | US (FDA) | RESTORIL | — | 1981-02-27 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT00245661 | Oct 2005 → Aug 2007 | chronic obstructive pulmonary disease | Rijnstate Hospital | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00940550 Comparator | Jul → Aug 2009 | insomnia | University of Surrey | Completed | No outcome recorded |
| Phase 4 | NCT02153788 Comparator | Sep 2009 → Sep 2010 | insomnia | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00465972 Comparator | Mar 2007 → Aug 2010 | HIV infectious disease, insomnia | Duke University | Completed | No outcome recorded |
| — | NCT02288923 Comparator | Mar 2015 → Jul 2018 | osteoarthritis, knee | Royal Devon and Exeter NHS Foundation Trust | Completed | No outcome recorded |
| — | NCT01519544 Comparator | Mar → Jul 2012 | sleep disorder | Massachusetts General Hospital | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | temazepam | “Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem” NCT02033707 ↗7“Patients may be given anxiolysis using temazepam 10-20mg or diazepam 2-5mg by mouth if required.” NCT02288923 ↗ |
| Known as | (rs)-temazepam | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Known as | Kentepam | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Known as | Normison | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Known as | NSC-246303 | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Known as | Restoril | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Known as | Temaz | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Known as | Temazepam civ | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Known as | WY-3917 | ChEMBL registry synonym — accepted as the source's own label CHEMBL967 ↗ |
| Modality | Small molecule | — CHEMBL967 ↗ |
| Route | Oral | “Temazepam capsule 15 mg po nightly x duration of study” NCT00465972 ↗ |