Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Temazepam
Drug ID BADD_D02148
Description 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 [A175207, A175210, F3718, F3721]. Although the chemical synthesis of temazepam was established by 1965 [A175333], 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 [A175339]. 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.
Indications and Usage Temazepam is specifically indicated only for the short-term management of insomnia [FDA Label], [L5539]. 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 [F3718]. 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 [FDA Label, F3718]. 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 [F3718]. Some regional prescribing information also notes that temazepam may be used for premedication prior to minor surgery or other related procedures [L5539].
Marketing Status approved; investigational
ATC Code N05CD07
DrugBank ID DB00231
KEGG ID D00370
MeSH ID D013693
PubChem ID 5391
TTD Drug ID D04BNP
NDC Product Code 46708-382; 61919-264; 62332-379; 62332-380; 63629-8601; 63629-8602; 63629-8605; 68788-6986; 70518-2008; 35356-663; 43353-152; 0228-2077; 55289-660; 60429-507; 61919-438; 62332-382; 63187-132; 63629-1054; 67877-146; 0406-9959; 68084-549; 71335-2043; 80425-0295; 0904-6436; 48087-0045; 35356-821; 62332-381; 63629-1621; 65162-556; 67877-149; 0406-9962; 68788-7163; 68788-8139; 70518-3227; 70518-3229; 71205-915; 63629-8604; 63739-003; 65162-583; 67877-147; 67877-148; 71205-914; 71335-9741; 71610-626; 43547-612; 43547-614; 53489-651; 60760-959; 63629-8606; 65162-557; 0406-9916; 70518-2487; 70518-3605; 71335-0315; 71610-625; 43547-611; 46708-379; 60429-506; 63629-1619; 63629-8603; 67544-136; 0406-9915; 0406-9917; 65015-746; 35356-664; 50090-0285; 65162-584; 68071-2581; 0406-9960; 0406-9961; 70518-0647; 71610-086; 71610-101; 12828-0022; 64330-088; 43353-312; 43547-613; 46708-380; 0228-2076; 53489-650; 55289-196; 63187-497; 63187-718; 71610-089; 0406-9914; 70518-2926; 71335-0527; 71335-1901; 43353-260; 63629-1057; 66267-321; 68788-8081; 70518-3093; 71610-004; 80425-0191; 48087-0016; 46708-381; 50090-0186; 53489-648; 53489-649
UNII CHB1QD2QSS
Synonyms Temazepam | Hydroxydiazepam | Oxydiazepam | 3-Hydroxydiazepam | 3 Hydroxydiazepam | Methyloxazepam | Planum | PMS-Temazepam | PMS Temazepam | Pronervon T | Remestan | Restoril | Ro-5-5345 | Ro 5 5345 | Ro55345 | SaH 47-603 | SaH 47 603 | SaH 47603 | Signopam | Temaze | Temazep Von Ct | Von Ct, Temazep | Tenox | WY-3917 | WY 3917 | WY3917 | Apo-Temazepam | Apo Temazepam | Dasuen | Euhypnos | Gen-Temazepam | Gen Temazepam | Levanxol | Norkotral Tema | Tema, Norkotral | Normison | Temtabs | Nocturne | Normitab | Nortem | Novo-Temazepam | Novo Temazepam | Nu-Temazepam | Nu Temazepam
Chemical Information
Molecular Formula C16H13ClN2O2
CAS Registry Number 846-50-4
SMILES CN1C2=C(C=C(C=C2)Cl)C(=NC(C1=O)O)C3=CC=CC=C3
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Disturbance in attention19.21.02.002; 17.03.03.0010.000263%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug abuse19.07.06.0100.000862%Not Available
Drug ineffective08.06.01.0060.002191%Not Available
Drug interaction08.06.03.0010.000443%Not Available
Dry mouth07.06.01.002--
Dysarthria19.19.03.001; 17.02.08.001--
Dysphagia07.01.06.0030.000120%
Dyspnoea02.11.05.003; 22.02.01.004--
Dyspraxia17.02.03.0070.000120%Not Available
Euphoric mood19.04.02.006--
Extrapyramidal disorder17.01.02.007--
Eye irritation06.04.05.003--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Feeling jittery08.01.09.0160.000263%Not Available
Fibroma16.02.02.010; 15.09.01.0040.000120%Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.000443%
Hallucination19.10.04.0030.000180%
Hallucination, visual19.10.04.0070.000120%Not Available
Hangover08.01.09.018--Not Available
Headache17.14.01.001--
Hostility19.05.01.003--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.0280.000263%
Hyperkinesia17.01.02.0080.000120%Not Available
Hypersensitivity10.01.03.003--
Hyponatraemia14.05.04.002--
Hypotension24.06.03.0020.000239%
Hypothermia12.05.03.001; 08.05.01.003--
Insomnia19.02.01.002; 17.15.03.0020.000766%
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