![]() The TGA encourages doctors not to prescribe and pharmacists not to dispense more than a single pack at one time. This step was taken on the advice of the Australian Drug Evaluation Committee with the intention of reducing exposure to the risk of these worrying and potentially dangerous adverse effects. TGA required that packs be labelled with a warning about alcohol and that the pack sizes of zolpidem products be reduced such that, from 31st December 2007, no packs containing greater than 14 tablets have been distributed in Australia by sponsors. It is also noted that such side effects can occur at therapeutic doses, without concomitant intake of alcohol and that alcohol intake heightens the risk of such side effects. People experiencing these effects have had no memory of the events." These have also included preparing and eating food, making phone calls or having sexual intercourse. Sleep walking, driving motor vehicles and other unusual and on some occasions dangerous behaviours whilst apparently asleep.These have included rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour. The updated CMI information about side effects of zolpidem includes: ![]() These effects are not limited to initial doses and can manifest for the first time after periods of apparently uneventful use.Īs a response to these observed adverse effects, significant changes were made by sponsors to the Product Information (PI) and Consumer Medicine Information (CMI) documents for products containing zolpidem. The very marked increase in reporting followed the publication of the February 2007 Australian Adverse Drug Reactions Bulletin which reminded prescribers of an association found between zolpidem and adverse neurological and psychiatric reactions, including changes in behaviour and mental state as well as specific effects such as sleep walking, and undertaking strange and potentially dangerous behaviours while apparently asleep. 103 reports (10% of all reports) included mention of sleep driving. 394 of the 1032 reports included mention of abnormal sleep related events including sleep-walking, sleep-eating and sleep driving. More than two thirds of these reports (687) have been received in the last twelve months. Up to 4 January 2008, 1032 Australian reports of suspected reactions to zolpidem products have been entered into the TGA's Adverse Reactions database. Limit use to four weeks maximum under close medical supervision." Caution is needed with other CNS depressant drugs. Zolpidem is not to be taken with alcohol. The wording of the boxed warning for zolpidem is " Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. The warning is highlighted by a bold black surround or "box". This follows continuing Australian reporting of bizarre and sometimes dangerous sleep related behaviours such as sleep walking and sleep driving in some users of zolpidem.Ī boxed warning is a succinct warning statement printed at the start of the approved product information, designed to alert prescribers to an important safety issue with a medicine. The TGA has on 21 February 2008 imposed a boxed warning in the product information documents for medicines containing zolpidem.
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