Lormetazepam


Generic Medicine Info
Indications and Dosage
Oral
Short-term management of insomnia
Adult: 0.5-1.5 mg once daily at bedtime. Dosage is individualised and may be increased depending on patient response and tolerability. Max treatment duration: 4 weeks (including dose tapering).
Elderly: 0.5 mg once daily at bedtime.
Renal Impairment
Dose reduction may be necessary.
Hepatic Impairment
Mild to moderate: Dose reduction may be necessary. Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Severe respiratory insufficiency, sleep apnoea, myasthenia gravis. As single agent for the treatment of insomnia associated with depression. Severe hepatic impairment. Pregnancy and lactation.
Special Precautions
Patient with depression, mild to moderate chronic respiratory insufficiency, CV or cerebrovascular disease, personality disorders, narrow angle glaucoma, history of alcohol or drug abuse. Not indicated for the primary treatment of depressive disorders or psychotic illness. Avoid abrupt withdrawal. Mild to moderate hepatic impairment and renal impairment. Elderly, debilitated, and patients at risk of falls. Concomitant use with opioids.
Adverse Reactions
Significant: Blood dyscrasias, respiratory depression, CNS depression, anterograde amnesia, sleep related activities (e.g. sleep-driving), paradoxical reactions (e.g. restlessness, agitation, irritability, aggressive behaviour, rage, delusion, hallucinations, nightmares, psychoses), encephalopathy, elevated liver enzymes, suicidal ideation, physical and psychological dependence. Rarely, hypotension.
General disorders and administration site conditions: Asthenia, fatigue.
Musculoskeletal and connective tissue disorders: Muscle weakness.
Nervous system disorders: Daytime drowsiness, sedation, dizziness, ataxia.
Patient Counseling Information
This drug may cause sedation, amnesia, dizziness, and impaired cognitive or muscular function, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor CBC, LFT, renal function, and respiratory status.
Overdosage
Symptoms: Mild cases: Drowsiness, mental confusion, lethargy; serious cases especially when other CNS depressant drugs or alcohol is ingested: ataxia, hypotension, hypotonia, respiratory depression, coma. Very rarely, death. Management: Supportive and symptomatic treatment. Induce vomiting or perform gastric lavage if ingestion is recent. Activated charcoal may be given if gastric emptying is not advantageous. Control hypotension with noradrenaline. Administer flumazenil as antidote.
Drug Interactions
Increased risk of profound sedation, respiratory depression, coma, and death with opioids. Enhanced CNS depressant effect with barbiturates, antipsychotics, antidepressants, antihistamines, anticonvulsants, anaesthetics, other sedative/hypnotics, and anxiolytics. Increased activity with CYP450 inhibitors. Decreased sedative activity with theophylline or aminophylline. Increased hypotensive effect with antihypertensive agents.
Food Interaction
May potentiate the CNS depressant effect of alcohol.
Action
Description: Lormetazepam is a short acting benzodiazepine with anxiolytic, muscle relaxant, sedative and hypnotic effects. It has minimal effects on REM sleep and next-day psychomotor performance.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Bioavailability: Approx 80%. Time to peak plasma concentration: Approx 2 hours.
Distribution: Enters breastmilk (small amounts). Plasma protein binding: 88%.
Metabolism: Metabolised in the liver to an inactive glucuronide.
Excretion: Via urine (86% ±14.9%) and faeces (<3%) as conjugate. Elimination half-life: 11 hours.
Chemical Structure

Chemical Structure Image
Lormetazepam

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 13314, Lormetazepam. https://pubchem.ncbi.nlm.nih.gov/compound/Lormetazepam. Accessed Mar. 25, 2021.

Storage
Protect from light.
ATC Classification
N05CD06 - lormetazepam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.
References
Anon. Lormetazepam. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 16/02/2021.

Buckingham R (ed). Lormetazepam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/02/2021.

Joint Formulary Committee. Lormetazepam. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/02/2021.

Lormetazepam 0.5 mg Tablets (TEVA UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/02/2021.

Lormetazepam 1 mg Tablets (TEVA UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/02/2021.

Disclaimer: This information is independently developed by MIMS based on Lormetazepam 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
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