Healthy Skepticism Library item: 10342

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Fanning E, Lumb K
The Stilnox dilemma
Sunday programme, ninemsn (Australia) 2007 Jun 3
http://sunday.ninemsn.com.au/sunday/cover_stories/article_2217.asp

Notes:

Video excerpts of programme can be accessed via link to ninemsn site.

Full text:

Over one million boxes of the sleeping tablets Stilnox were dispensed in Australia last year. SUNDAY examines the frightening abnormal behaviours that can be triggered by this drug during sleep, adverse reactions that have potentially dangerous consequences. With the assistance of medical experts here and in the United States, SUNDAY has examined some of the alarming reactions being claimed by hundreds of Stilnox users in Australia. The reactions range from eating and drinking while asleep, driving while asleep and self harm – including self mutilation, all while under the influence of the drug. The victims of this medical scandal reveal the full of extent of the apparent reactions and the ongoing psychological damage they’ve experienced …

For further information on the research by Dr Carlos Schenck at the Minnesota Regional Sleep Disorders Centre in the USA, visit www.sleeprunners.com. On this website you will find his documentary Sleep Runners as well as a link to his book Sleep: The Mysteries, The Problems, and The Solutions published in March by Penguin/Avery Press.

Letter from Alan Brindell, Director of Communications, Sanofi-aventis

Attention: Ellen Fanning
Re: Stilnox (Zolpidem)

I refer to your request this afternoon for information regarding Stilnox (zolpidem).

Sanofi-aventis is committed to patient health and safety and treats matters of patient safety with the highest degree of importance. As with all of our products, Sanofi-aventis continues to closely monitor the safety profile of zolpidem, and we regularly communicate with health authorities as part of normal post-marketing surveillance of our products.
In agreement with the Therapeutic Goods Administration (TGA), the Product Information (PI) documents for zolpidem have been revised to reflect post-marketing observations suggesting a potential for rare cases of sleep walking and associated complex behaviours in some patients taking zolpidem. The revised zolpidem PI now include the following contraindication: Prior or concomitant intake with alcohol.

The Precautions section now includes information on somnambulism and associated behaviours, including the observation that the use of alcohol, other CNS depressants, and the use of zolpidem at doses exceeding the maximum recommended dose, appear to increase the risk of such behaviours. Information on an interaction between zolpidem and alcohol, and effects on the ability to drive and use machinery when using zolpidem, has also been reinforced.

The Consumer Medicine Information for zolpidem has also been revised to reflect the changes to the Product Information.
In the company’s opinion a causal relationship between the complex behaviours referred to above and zolpidem has not been established due to the fact that it is difficult to determine with certainty whether a particular complex sleep-related behaviour is drug induced, spontaneous in origin, or a result of an underlying condition.
The incidence of somnambulism in the general adult population is reported to be approximately 2 to 4 percent. Analysis of post-marketing surveillance has found the reported incidence of somnambulism in association with zolpidem to be rare (0.01-0.1 percent) and this is consistent with the current zolpidem Product Information.
More than six million Australians suffer from insomnia, which can be a serious medical condition affecting work performance, their relationships, their health, and may cause significant distress. Zolpidem, which can only be prescribed by a physician and dispensed by a pharmacist, is an important treatment in the field of insomnia when prescribed in accordance with the prescribing information. Zolpidem is supported by 19 years of worldwide real-world use of treating insomnia.

As with any treatment, patients should discuss decisions regarding their treatment with their doctor.

Alan Brindell
Director of Communications
Australia and New Zealand
Sanofi-aventis