The February 2007 Australian Adverse Drug Reactions Bulletin again alerted prescribers to an association found between Zolpidem ( Ambien, Stilnox ) 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. These effects are not limited to initial doses and can manifest for the first time after periods of apparently uneventful use.

As a response to these observed adverse effects, significant changes have been made to the Product Information and Consumer Medicine Information documents for products containing Zolpidem.

The updated Consumer Medicine Information information about side effects of Zolpidem now includes:

" Less common adverse effects include:

a) Unexpected changes in behaviour. These have included rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour.

b) Sleep walking, driving motor vehicles and other unusual and on some occasions dangerous behaviours whilst apparently asleep. These have also included preparing and eating food, making phone calls or having sexual intercourse. People experiencing these effects have had no memory of the events."
c)
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.

Further, the pack sizes have been reduced such that, from 31st December 2007, no packs containing greater than 14 tablets will be distributed in Australia.
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.

As with any medicine, healthcare professionals and patients must assess the risks and benefits of use in their individual clinical situation. If, after consideration of the risks of adverse events associated with Zolpidem, the decision is made to use Zolpidem patients should do so for as short a period as possible, at the lowest dose possible.

Source: TGA, 2007

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