"Sleep driving" drug should remain on the shelves says TGA

By Gareth Macdonald

- Last updated on GMT

stilnox TGA Australia
An insomnia treatment linked to sleepwalking and sleep driving should stay on the market according to the Australian Therapeutic Good Administration (TGA).  

The drug in questions is Stilnox - a generic version of an insomnia pill developed by Sanofi Aventis, has been a controversial subject in Australia for years following a series of high-profile side-effect related events - including a number of deaths​ – that prompted some to call for a ban.

However, the TGA did not ban the drug and opted instead – in 2008 – to revise its label to include a warning that it “may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours​.”

But despite the new warnings the pill hit the headlines again this year following the publication of an article in the Journal of Forensic Sciences in March​ which examined adverse events associated with it that occurred between 2009 and April.

In a statement published last week the TGA said that the drug “is a medicine of value to some patients, particularly with severe insomnia, and should remain available for use in Australia.”

The TGA said: “Over this period the annual numbers of these types of adverse events have been decreasing which suggests that the boxed warning added to the Product Information (PI)​ and other changes made in 2008 has been effective in ensuring the safer use of zolpidem.​”

The agency added that no new safety concerns had emerged and that it will not take any further action at this time.

The purpose of the MSU article was to remind prescribers of the importance of following the advice in the PI and of continuing to report any adverse events.  Such reports enable the TGA to continue monitoring the safety of the drug​."

Related topics: Regulations, Regulatory & Safety

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