MedPath

Temazepam

Generic Name
Temazepam
Brand Names
Restoril
Drug Type
Small Molecule
Chemical Formula
C16H13ClN2O2
CAS Number
846-50-4
Unique Ingredient Identifier
CHB1QD2QSS

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.

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

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PMS-TEMAZEPAM - 15MG
02229455
Capsule - Oral
15 MG
10/17/1996
PHL-TEMAZEPAM
pharmel inc
02297965
Capsule - Oral
30 MG
7/27/2007
GEN-TEMAZEPAM 30MG
genpharm ulc
02231616
Capsule - Oral
30 MG
7/8/1997
PMS-TEMAZEPAM - 30MG
02229456
Capsule - Oral
30 MG
10/17/1996
TEMAZEPAM-15
PRO DOC LIMITEE
02229760
Capsule - Oral
15 MG
8/6/1997
TEVA-TEMAZEPAM
teva canada limited
02230095
Capsule - Oral
15 MG
12/10/1996
GEN-TEMAZEPAM 15MG
genpharm ulc
02231615
Capsule - Oral
15 MG
7/8/1997
TEMAZEPAM-30
PRO DOC LIMITEE
02229761
Capsule - Oral
30 MG
8/6/1997
DOM-TEMAZEPAM
dominion pharmacal
02229756
Capsule - Oral
15 MG
12/16/1996
RATIO-TEMAZEPAM
ratiopharm inc division of teva canada limited
02243024
Capsule - Oral
30 MG
2/19/2001

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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