Temazepam


Generic Medicine Info
Indications and Dosage
Oral
Short-term management of insomnia
Adult: Initially, 7.5-15 mg once daily at bedtime, as necessary; may increase to 30 mg at bedtime, if necessary, according to response and tolerability. Alternatively, 10-20 mg once daily at bedtime; in exceptional circumstances, may increase dose to 30-40 mg once daily at bedtime. Use the lowest effective dose for the shortest possible duration. Gradually taper dose when discontinuing treatment or reducing the dosage, particularly after continued use. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Elderly: Initially, 7.5 mg once daily at bedtime, as necessary. Alternatively, 10 mg once daily at bedtime; in exceptional circumstances, may increase dose to 20 mg once daily at bedtime. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Premedication in surgery
Adult: Usual dose: 20-40 mg given 30-60 minutes before the surgery or other procedures.
Elderly: Up to half of the usual adult dose may be sufficient.
Special Patient Group
Short-term management of insomnia:
Debilitated patients: Initially, 7.5 mg once daily at bedtime, as necessary. Alternatively, 10 mg once daily at bedtime. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Renal Impairment
Short-term management of insomnia:
May consider dose reduction. Recommendations may vary among countries and individual products (refer to specific product guidelines).
Hepatic Impairment
Short-term management of insomnia:
Mild to moderate: Dose reduction may be needed. Recommendations may vary among countries and individual products (refer to specific product guidelines). Severe: Contraindicated.

Premedication in surgery:
Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Respiratory depression, acute pulmonary insufficiency, sleep apnoea syndrome, myasthenia gravis, chronic psychosis, phobic or obsessional states, acute narrow-angle glaucoma. Severe hepatic impairment.
Special Precautions
Patient with chronic pulmonary insufficiency, personality disorder, severe depression or evidence of latent depression, convulsive disorder, organic brain changes (particularly arteriosclerosis), history of alcohol or drug abuse or dependence. Not recommended as monotherapy in patients with depression or anxiety associated with depression. Continuous long-term use is not recommended. Avoid abrupt withdrawal. Renal and mild to moderate hepatic impairment. Elderly or debilitated patients. Pregnancy and lactation.
Adverse Reactions
Significant: CNS depression, drug dependence, abuse or tolerance; increased risk of falls (particularly in elderly), withdrawal symptoms (particularly after abrupt discontinuation), anterograde amnesia, complex sleep-related behaviour (e.g. sleep-driving; cooking and eating food or making phone calls while asleep), psychiatric and paradoxical reactions (e.g. irritability, restlessness, confusion, excitement, hallucinations, agitation, aggression, rages, psychoses); blood dyscrasias, increased liver enzymes. Rarely, hypotension.
Cardiac disorders: Palpitations.
Ear and labyrinth disorders: Vertigo.
Eye disorders: Blurred vision, diplopia, nystagmus, burning sensation of eyes.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, dry mouth, abdominal discomfort.
General disorders and administration site conditions: Weakness, fatigue, lethargy, hangover effect.
Hepatobiliary disorders: Rarely, jaundice.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Drowsiness, dizziness, headache, ataxia, tremors, dysarthria.
Psychiatric disorders: Euphoria.
Renal and urinary disorders: Urinary retention or incontinence.
Reproductive system and breast disorders: Change in libido.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Skin and subcutaneous tissue disorders: Hyperhidrosis, rash.
Potentially Fatal: Respiratory depression. Rarely, anaphylaxis or angioedema (involving the tongue, larynx, or glottis).
PO: Z (Neonatal apnoea, bradycardia and hypotonia were reported after maternal use during labour. Use during pregnancy is generally not recommended. Consult product literature for specific recommendations.)
Patient Counseling Information
This drug may cause drowsiness, dizziness, sedation, amnesia, impaired concentration or muscle function, or blurred vision, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor respiratory or CV status. Assess for individual risk for abuse, misuse, and addiction before and during treatment.
Overdosage
Symptoms: Drowsiness, mental confusion, dysarthria, lethargy, ataxia, nystagmus, hypnotic state, hypotonia, diminished reflexes, and in severe cases, hypotension, respiratory depression, and coma. Rarely, paradoxical or disinhibitory reactions (e.g. agitation, irritability, impulsivity, violent behaviour, restlessness, excitement, talkativeness). Management: Supportive treatment. Maintain a clear airway and adequate ventilation and administer IV fluids. May administer activated charcoal to reduce absorption, provided that the patient is not too drowsy. Flumazenil may be considered as an adjunct to supportive management; flumazenil must not be used in mixed overdoses.
Drug Interactions
May enhance CNS depressant effects with barbiturates, antipsychotics, antidepressants, sedative antihistamines, anticonvulsants, anaesthetics, skeletal muscle relaxants (e.g. tizanidine), nabilone, lofexidine, other hypnotics or anxiolytics. May reduce sedative effect with theophylline or aminophylline. May enhance sedative effect with cisapride and disulfiram. Increased hypersalivation with clozapine.
Potentially Fatal: Increased risk of sedation, respiratory depression, and coma with opioids.
Food Interaction
Additive CNS depressant effect with alcohol.
Action
Description:
Mechanism of Action: Temazepam is a short- to intermediate-acting benzodiazepine with anxiolytic, hypnotic and sedative characteristics, as well as possible muscle relaxant properties. It binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron within the CNS and potentiates the GABA inhibitory effect by increasing neuronal membrane permeability to chloride ions which results in hyperpolarisation and stabilisation.
Pharmacokinetics:
Absorption: Readily and well absorbed from the gastrointestinal tract. Time to peak plasma concentration: 1.2-1.6 hours.
Distribution: Crosses the placenta and enters breast milk. Volume of distribution: 1.3-1.5 L/kg. Plasma protein binding: Approx 96%.
Metabolism: Principally metabolised in the liver via conjugation into inactive glucuronide, some are demethylated into oxazepam.
Excretion: Mainly via urine (80-90% as inactive metabolites; <2% as unchanged drug); faeces (12%). Elimination half-life: 3.5-18.4 hours.
Chemical Structure

Chemical Structure Image
Temazepam

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5391, Temazepam. https://pubchem.ncbi.nlm.nih.gov/compound/Temazepam. Accessed Oct. 26, 2023.

Storage
Store between 15-30°C. Protect from light.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CD07 - temazepam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.
References
Anon. Temazepam. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 21/07/2023.

Anon. Temazepam. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 21/07/2023.

Buckingham R (ed). Temazepam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/07/2023.

Joint Formulary Committee. Temazepam. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/07/2023.

Pharmacy Retailing (NZ) Limited. Normison 10 mg Tablet data sheet 14 March 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 21/07/2023.

Restoril Capsule (SpecGx LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 21/07/2023.

Temazepam 10 mg/5 mL Oral Solution (EnzymeX Ltd). MHRA. https://products.mhra.gov.uk. Accessed 21/07/2023.

Temazepam 20 mg Tablets (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 21/07/2023.

Temazepam. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 27/09/2023.

Disclaimer: This information is independently developed by MIMS based on Temazepam from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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