Zolpidem


Concise Prescribing Info
Indications/Uses
Short-term management of insomnia.
Dosage/Direction for Use
Adult: PO Immediate release: 5-10 mg at bedtime. Max: 10 mg/day; extended release 6.25-12.5 mg at bedtime. Max: 12.5 mg/day. Max duration: 4 wk including tapering.
Administration
Should be taken on an empty stomach. Do not take w/ or immediately after a meal.
Contraindications
Severe hepatic impairment.
Special Precautions
Obstructive sleep apnoea, myasthenia gravis, compromised respiratory function. Patients exhibiting symptoms of depression. History of drug or alcohol abuse. Avoid abrupt withdrawal and rapid dose reduction after prolonged therapy. Re-evaluate if insomnia fail to remit after 7-10 days as this may indicate the presence of underlying psychiatric and/or medical condition. Pregnancy, lactation, childn <18 yr. Patient Counseling Patients should be warned about performing activities involving mental alertness or physical coordination after drug intake.
Adverse Reactions
Atypical thinking and behaviour, hallucination, nightmare, somnolence, somnambulism, headache, nausea, vomiting, dizziness, vertigo, drowsiness, asthenia, ataxia, rebound insomnia, amnesia, GI disturbances, upper and lower respiratory tract infection, fatigue, visual disturbances, increased ALT serum concentrations, abnormal LFT.
Potentially Fatal: Hepatitis, anaphylactic reactions, angioedema, sleep-driving (driving while not fully awake after drug intake, w/ no recollection of the event).
Drug Interactions
Flumazenil reverses the sedative/hypnotic effect of zolpidem. Increased depressant effects w/ CNS depressants (e.g. sedatives, antihistamines, alcohol). Additive effect on decreased alertness and psychomotor performance w/ imipramine and chlorpromazine. Increased plasma concentration w/ itraconazole, ketoconazole and other CYP3A4 inhibitors. May decrease plasma concentration w/ CYP3A4 inducers (e.g. carbamazepine). Reduced hypnotic effect w/ rifampicin.
ATC Classification
N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Disclaimer: This information is independently developed by CIMS based on zolpidem from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 CIMS. All rights reserved. Powered by CIMSAsia.com
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