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`Bizarre` Stilnox gets warning inside packet

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I just have to say this: YES drugs can have side effects, even if you use them 100% correctly and NO these do not affect everyone the same.I have no direct experience with this particular drug, but just because some people claim to use it without any trouble doesn't mean that those who have experienced side effects are irresponsible abusers of the drug.

Posted by: biochemist of ACT 10:12am today

I worked as a Sales Rep for Sanofi for a number of years and my first line drug was Stilnox. When taken properly, the side effects, compared to those of benzodiazapines such as Valium, Temazapam and others, are rare. I think that it needs to be put in to perspective that there will always be side effects, and Stilnox is no different. It is prescribed for the temporary relief of insomnia, and should not be prescribed for periods of longer than one month. Certainly, all of these people who are somewhat hysterically calling for Stilnox to be removed from the shelves are being a little melodramatic. Be responsible with it, and you will reduce the possibility of adverse reactions.

Posted by: Sales Rep of Australia 10:04am today

Why can't we ban this killer drug b4 more people get killed? It's been argued for years.

Posted by: James of Melb. 9:58am today
Read all 39 comments

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  • TGA slaps "black box" warning on Stilnox
  • Sleeping pill has bizarre side effects
  • Not enough evidence to put in morphine category

AUSTRALIA`S drug regulator has slapped a "black box" warning on the sleeping drug Stilnox, saying the public and even some doctors remain unaware of the "serious consequences" it can cause for some patients.

Stilnox, the best-known of several brand names for the drug zolpidem, has come under intense scrutiny after hundreds of reports of patients walking, cooking and even crashing cars while asleep after taking the drug.

The Therapeutic Goods Administration said yesterday the boxed warning was necessary because it was "important that healthcare professionals and the public are advised about these side effects".

However, a TGA committee, the National Drugs and Poisons Schedule Committee, also said yesterday it had decided not todeclare zolpidem a drug of abuse – a move that would have put it in the same category as morphine.

The committee said that while it "acknowledges the concerns that members of the public have raised" about the reported side effects, there was "no compelling evidence" that it should be classified a "schedule 8" drug.

Dangerous sleep behaviours

The boxed warning – which will appear on prescribing information included inside the product packaging – will say that the drug "may be associatedwith potentially dangerous complex sleep-related behaviours which may include sleepwalking, sleep driving and other bizarre behaviours".

It also warns that zolpidem should never be taken with alcohol, that "caution is needed" when taking other drugs that depress the central nervous system, and that patients should not take it for more than four weeks.

In some cases – including that of 30-year-old Sydney woman Mairead Costigan, who fell to her death from the Sydney Harbour Bridge nearly six months ago – the drug had been prescribed for eight months or more.

However, Ms Costigan had switched to another sleeping pill, zopiclone, six days before her death.

"Not surprised"

The TGA said it would meet officials from the National Prescribing Service to strengthen information material for doctors.

Yesterday`s decisions seem unlikely to end the controversy over zolpidem.

Costigan`s sister, Siobhan Costigan, said her family was "very disappointed but sadly not surprised" by the move, as they had been unaware of the NDPSC`s meeting until it was reported by the media 48 hours before the deadline for submissions.

"We strongly believe that the attempts by the TGA to increase warnings about the potential dangers of these drugs do not go far enough in alerting the general public to the serious and potentially devastating side effects these drugs can cause," Ms Costigan said.

"I can assure the TGA that this is only the beginning for us, and we will continue to fight this until Australians are safe from this dangerous and deadly drug."

Some experts backed the NDPSC`s move.

Sleep physician Ron Grunstein, president of the World Federation of Sleep Research Societies, said the decision was "the only decision the NDPSC could make based on the scientific evidence".

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Today`s Top Picks

Sex scandal reaches Premier

FIVE ministers and a the NSW Premier Morris Iemma`s office have been drawn into the ICAC sex for development scandal.



Font size: +-

Send this article:PrintEmail

Have Your Say

Latest Comments:

I just have to say this: YES drugs can have side effects, even if you use them 100% correctly and NO these do not affect everyone the same.I have no direct experience with this particular drug, but just because some people claim to use it without any trouble doesn't mean that those who have experienced side effects are irresponsible abusers of the drug.

Posted by: biochemist of ACT 10:12am today

I worked as a Sales Rep for Sanofi for a number of years and my first line drug was Stilnox. When taken properly, the side effects, compared to those of benzodiazapines such as Valium, Temazapam and others, are rare. I think that it needs to be put in to perspective that there will always be side effects, and Stilnox is no different. It is prescribed for the temporary relief of insomnia, and should not be prescribed for periods of longer than one month. Certainly, all of these people who are somewhat hysterically calling for Stilnox to be removed from the shelves are being a little melodramatic. Be responsible with it, and you will reduce the possibility of adverse reactions.

Posted by: Sales Rep of Australia 10:04am today

Why can't we ban this killer drug b4 more people get killed? It's been argued for years.

Posted by: James of Melb. 9:58am today
Read all 39 comments

We welcome your comments on this story. Comments are submitted for possible publication on the condition that they may be edited. Please provide your full name. We also require a working email address - not for publication, but for verification. The location field is optional.Read our publication guidelines.

Submit your feedback here:

(So you don`t have to retype your details each timeyou send feedback.)

Video

KatalystWatch this Video NOW!
Katalyst

THE Aussie Producer on a typical day for him, the Black Eyed Peas and why he`s a neat freak.

Latest videos

More Video

Advertisement

Love & Relationships - Find a date near you on Match.com - # 1 Online Dating site Worldwide.
 
What`s On in New Zealand. Find out What`s On in Dunedin & Southern New Zealand.
 
Virgin Mobile Cheap calls & text across Australia.
 
TIC TAC Taste of Music WIN the ultimate music experience 12 double passes to 12 concerts.
 
Kodak All-in-One Printers Save up to 50% on everything you print! Black ink only $14.99 RRP.
 
Get a higher return Earn a high 7.88% p.a.^ on a 3 month Term Deposit with HSBCPremier.
 
Want to be instantly better off? Find the best Health Insurance online now.
 
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