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Controversial sleep drug to carry updated warning
The Age
November 28, 2007
THE controversial sleeping drug Stilnox will be sold in packs of no greater than 14 tablets and will come with updated warnings about potential bizarre side-effects such as sleep-driving and sleep-sex.
The reduced maximum pack size, down from 21, comes after almost 1000 calls regarding the drug to the Brisbane-based Adverse Medicine Events Line.
Users of the drug, generically known as zolpidem, have complained about strange and potentially dangerous side-effects including sleep-walking over balconies and binge-eating while apparently asleep.
At least two people have died after taking the insomnia medication, including a Sunshine Coast man who took his motorbike out in the middle of the night and crashed.
The Therapeutic Goods Administration said Stilnox packs would include significantly changed Consumer Medicine Information warning of common side-effects such as "rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour".
It also warns of "sleep-walking, driving motor vehicles, preparing and eating food, making phone calls or having sexual intercourse" while asleep and on the drug.
"People experiencing these effects have had no memory of the events," the warning states.
A drug reactions hotline fielded 500 calls from Stilnox users who reported odd behaviours after popping a pill.
One patient gained 23kg over seven months after eating from the refrigerator while asleep. Another patient woke up with a paintbrush in her hand after painting the front door.
Pharmacist Geraldine Moses welcomed the changes.
"I think it's a good thing but a huge problem we have is that people don't read the product information leaflets," she said, speaking on behalf of the Pharmaceutical Society of Australia's Queensland branch.
"Every pharmacist has got a story of at least one of their Stilnox patients having a reaction. Most pharmacists think that the average experience of this drug is without a problem, it's just that when there has been a problem it's often dramatic and frightening."
On its website, the TGA said it remained concerned about reports of adverse reactions.
It warned the reactions could occur among both first-time and regular users, at prescribed doses and without the consumption of alcohol.
Australians wanting to report adverse reactions to the drug should phone 1300 134 237.
Zolpidem is sold in Australia under the brand-names Dormizol, Zolpibell, Zolpixdem, Somidem and Stildem.
Link
The Age
November 28, 2007
THE controversial sleeping drug Stilnox will be sold in packs of no greater than 14 tablets and will come with updated warnings about potential bizarre side-effects such as sleep-driving and sleep-sex.
The reduced maximum pack size, down from 21, comes after almost 1000 calls regarding the drug to the Brisbane-based Adverse Medicine Events Line.
Users of the drug, generically known as zolpidem, have complained about strange and potentially dangerous side-effects including sleep-walking over balconies and binge-eating while apparently asleep.
At least two people have died after taking the insomnia medication, including a Sunshine Coast man who took his motorbike out in the middle of the night and crashed.
The Therapeutic Goods Administration said Stilnox packs would include significantly changed Consumer Medicine Information warning of common side-effects such as "rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour".
It also warns of "sleep-walking, driving motor vehicles, preparing and eating food, making phone calls or having sexual intercourse" while asleep and on the drug.
"People experiencing these effects have had no memory of the events," the warning states.
A drug reactions hotline fielded 500 calls from Stilnox users who reported odd behaviours after popping a pill.
One patient gained 23kg over seven months after eating from the refrigerator while asleep. Another patient woke up with a paintbrush in her hand after painting the front door.
Pharmacist Geraldine Moses welcomed the changes.
"I think it's a good thing but a huge problem we have is that people don't read the product information leaflets," she said, speaking on behalf of the Pharmaceutical Society of Australia's Queensland branch.
"Every pharmacist has got a story of at least one of their Stilnox patients having a reaction. Most pharmacists think that the average experience of this drug is without a problem, it's just that when there has been a problem it's often dramatic and frightening."
On its website, the TGA said it remained concerned about reports of adverse reactions.
It warned the reactions could occur among both first-time and regular users, at prescribed doses and without the consumption of alcohol.
Australians wanting to report adverse reactions to the drug should phone 1300 134 237.
Zolpidem is sold in Australia under the brand-names Dormizol, Zolpibell, Zolpixdem, Somidem and Stildem.
Link