Temazepam


Generic Medicine Info
Indications and Dosage
Oral
Short-term management of insomnia
Adult: 7.5-30 mg at bedtime for 7-10 days. Max: 40 mg.
Elderly: 5 mg at bedtime. May be increased to 10-20 mg in severe cases.

Oral
Premedication in surgery
Adult: 20-40 mg, 30 min to 1 hr before the procedure.
Elderly: 10-20 mg, 1 hr before the procedure.
Renal Impairment
Short-term management of insomnia: 5 mg at bedtime. May be increased to 10-20 mg in severe cases.
Hepatic Impairment
Short-term management of insomnia: 5 mg at bedtime. May be increased to 10-20 mg in severe cases. Severe: Contraindicated.
Premedication in surgery: Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Acute pulmonary insufficiency, resp depression, sleep apnoea, obsessional states, myasthenia gravis, severe hepatic impairment. Pregnancy.
Special Precautions
Patient w/ severe depression, chronic pulmonary insufficiency, personality disorders, history of alcohol or drug addiction. Avoid abrupt withdrawal. Renal and hepatic impairment. Elderly or debilitated patient. Lactation.
Adverse Reactions
Complex behaviour (e.g. sleep-driving, making phone calls, preparing and eating food). Dyspnoea, nausea and vomiting, throat closing, anterograde amnesia, agitation, restlessness, irritability, excitement, aggressiveness, rage, delusions, confusion, nightmares, psychoses, hallucinations, nervousness, dizziness, drowsiness, fatigue, headache, lethargy, hangover, anxiety, depression, euphoria, ataxia, anorexia, tremor and backache.
Potentially Fatal: Angioedema involving glottis, tongue or larynx.
Patient Counseling Information
May impair ability to perform tasks that require alertness (e.g. driving or operating machinery).
Monitoring Parameters
Monitor resp and CV status.
Overdosage
Symptoms: Somnolence, confusion, coma, reduced or absent reflexes, resp depression, and hypotension. Management: Supportive and symptomatic treatment. Empty stomach by vomiting or gastric lavage. Treat hypotension w/ IV pressor agents. IV fluids should be given to induce diuresis. Flumazenil may be used for the complete or partial reversal of the sedative effects but there is a risk of seizure esp in long-term benzodiazepine users and in cyclic antidepressant overdose.
Drug Interactions
May enhance CNS depressant effect w/ Na oxybate, antipsychotics, tranquilisers, neuroleptics, antidepressants, hypnotics, anaesth, analgesics, sedative antihistamines, barbiturates. Effect may be reduced w/ theophylline.
Food Interaction
May enhance sedative effect w/ alcohol.
Action
Description: Temazepam is a short-acting benzodiazepine w/ anxiolytic, hypnotic/sedative, muscle relaxant properties. It increases neuronal membrane permeability to Cl ions by binding to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron w/in the CNS and enhancing the GABA inhibitory effects resulting in hyperpolarisation and stabilisation.
Pharmacokinetics:
Absorption: Readily absorbed from the GI tract. Time to peak plasma concentration: 1.2-1.6 hr.
Distribution: Enters breast milk. Volume of distribution: 1.4 L/kg. Plasma protein binding: Approx 96%.
Metabolism: Minimal first-pass metabolism (8%). Completely metabolised through conjugation to inactive metabolite.
Excretion: Via urine (80-90% as inactive metabolites). Elimination half-life: Approx 8-15 hr.
Storage
Store at ≤25°C. Protect from light.
References
Anon. Temazepam. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/04/2014.

Buckingham R (ed). Temazepam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/04/2014.

Joint Formulary Committee. Temazepam. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/04/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Temazepam. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 15/04/2014.

Restoril Capsule (Mallinckrodt, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 15/04/2014.

Restoril Capsule. U.S. FDA. https://www.fda.gov/. Accessed 15/04/2014.

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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in