Overview
Temazepam, like many other similar and related benzodiazepines, acts as a gamma-aminobutyric acid (GABA) modulator and is capable of eliciting a variety of actions including sedation, hypnosis, skeletal muscle relaxation, anticonvulsant activity, and anxiolytic action . Although the chemical synthesis of temazepam was established by 1965 , mainstream contemporary use of the medication did not occur until it's legitimate use as treatment for insomnia was accepted and approved later on. In particular, before temazepam saw regular prescription use in civilians it was - and still is - employed by the US military as a sedative-hypnotic medication to be taken by soldiers, pilots, etc. to obtain the necessary rest required for medical recovery or scheduled maneuvers and operations . Regardless, temazepam has become one of the most frequently prescribed medications internationally and sees millions of prescriptions every year. Unfortunately, however, given its frequent use and the inherent nature of its pharmacological effects, temazepam - like many other benzodiazepines - possesses a high potential for misuse and is genuinely capable of developing drug tolerance, physical dependence, and addiction in users.
Background
Temazepam, like many other similar and related benzodiazepines, acts as a gamma-aminobutyric acid (GABA) modulator and is capable of eliciting a variety of actions including sedation, hypnosis, skeletal muscle relaxation, anticonvulsant activity, and anxiolytic action . Although the chemical synthesis of temazepam was established by 1965 , mainstream contemporary use of the medication did not occur until it's legitimate use as treatment for insomnia was accepted and approved later on. In particular, before temazepam saw regular prescription use in civilians it was - and still is - employed by the US military as a sedative-hypnotic medication to be taken by soldiers, pilots, etc. to obtain the necessary rest required for medical recovery or scheduled maneuvers and operations . Regardless, temazepam has become one of the most frequently prescribed medications internationally and sees millions of prescriptions every year. Unfortunately, however, given its frequent use and the inherent nature of its pharmacological effects, temazepam - like many other benzodiazepines - possesses a high potential for misuse and is genuinely capable of developing drug tolerance, physical dependence, and addiction in users.
Indication
Temazepam is specifically indicated only for the short-term management of insomnia , . Furthermore, such management is generally predominantly associated with the symptomatic relief of transient and short-term insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings . In particular, the official prescribing information for temazepam typically specifies that the instructions issued for dispensed prescriptions of the medication should indicate specifically that patients are only expected to use the therapy for short periods of time - usually 7-10 days in general . Subsequently, treatment with temazepam should usually not exceed 7 to 10 consecutive days and nor should it be prescribed in quantities exceeding a one-month supply . Some regional prescribing information also notes that temazepam may be used for premedication prior to minor surgery or other related procedures .
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/03/02 | Phase 3 | Terminated | |||
2014/06/03 | Phase 4 | Completed | |||
2012/01/27 | Not Applicable | Completed | |||
2009/07/16 | Phase 1 | Completed | |||
2007/04/27 | Phase 4 | Completed | |||
2005/10/28 | Phase 3 | Completed | Rijnstate Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Alembic Pharmaceuticals Inc. | 62332-381 | ORAL | 22.5 mg in 1 1 | 2/20/2023 | |
Aidarex Pharmaceuticals LLC | 33261-102 | ORAL | 30 mg in 1 1 | 8/16/2018 | |
Novel Laboratories, Inc. | 40032-123 | ORAL | 30 mg in 1 1 | 8/9/2012 | |
Bryant Ranch Prepack | 71335-0315 | ORAL | 15 mg in 1 1 | 11/11/2021 | |
Bryant Ranch Prepack | 72162-1825 | ORAL | 30 mg in 1 1 | 3/7/2024 | |
Amneal Pharmaceuticals LLC | 65162-556 | ORAL | 15 mg in 1 1 | 2/13/2023 | |
Amneal Pharmaceuticals LLC | 65162-557 | ORAL | 30 mg in 1 1 | 2/13/2023 | |
Sun Pharmaceutical Industries, Inc. | 53489-648 | ORAL | 7.5 mg in 1 1 | 2/26/2019 | |
Bryant Ranch Prepack | 63629-8606 | ORAL | 30 mg in 1 1 | 12/30/2020 | |
Major Pharmaceuticals | 0904-6436 | ORAL | 7.5 mg in 1 1 | 6/22/2022 |
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 |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
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 |
---|---|---|---|---|---|
Normison | 337011 | Medicine | A | 5/26/2020 | |
APO-TEMAZEPAM temazepam 10mg tablet blister pack | 153123 | Medicine | A | 1/22/2009 | |
NORMISON 10mg tablet blister pack | 41637 | Medicine | A | 9/30/1992 | |
TEMTABS temazepam 10mg tablet blister pack | 91058 | Medicine | A | 9/23/2002 | |
TEMAZEPAM-WGR 10mg tablet blister pack | 433370 | Medicine | A | 4/11/2024 | |
TEMAZE temazepam 10mg tablet bottle | 63863 | Medicine | A | 5/13/1998 | |
TEMAZE temazepam 10mg tablet blister pack | 408408 | Medicine | A | 9/7/2023 |