Boxed warnings now on popuar sleeping pill Stilnox

Aug 11 2008

The popular sleeping pill Stilnox now carries a warning about the potentially dangerous sleep-related behaviours linked to the drug.

The Australian Therapeutic Goods Administration (TGA) has placed a warning on product information documents regarding Stilnox and other medications containing the essential component zolpidem and recommends a limited use of no more than four weeks.

According to the National Prescribing Service (NPS), zolpidem has been associated with a variety of unusual sleep-related events, including sleepwalking, sleep eating and sleep driving, with patients later having no recollection of the event.

The NPS also recommends any hypnotics should be used in the lowest possible dose, for the shortest possible time, which is ideally less than two weeks.

The action by the TGA follows reports of bizarre and sometimes dangerous sleep related behaviours such as sleep walking and sleep driving in some users of the drug which may have serious consequences for users of zolpidem.

The TGA says it is important that healthcare professionals and the public are advised about these side effects and reminded of the need for careful prescribing and use of zolpidem and any other form of sleeping tablets.

The boxed warning follows the decision of the National Drugs and Poisons Scheduling Committee not to restrict access to zolpidem by moving it from Schedule 4 (prescription medicines) to Schedule 8 of the Standard for the Uniform Scheduling of Drugs and Poisons (medicines subject to potential abuse or illegal use).

The TGA had referred the status of zolpidem to NDPSC and had been awaiting its decision before taking any additional regulatory steps.

The TGA says such drugs are indicated for short term use only and should not be used with alcohol and also cautions that any sleep medicines act on the brain and is a particular issue particularly in patients taking other medicines such as antidepressants.

The TGA says it is vital that doctors ensure that sleeping medicines are only used according to their approved indications with appropriate medical monitoring.

In the past year, the TGA has published warnings about the risks of these medications, written to Australian doctors' and pharmacists' organisations, limited the size of packets of zolpidem available for dispensing to encourage only short term use, and revised the product information and consumer medicines information to explicitly warn of these side effects.

An urgent meeting scheduled between the TGA and the NPS will discuss the development of additional educational materials for prescribers to further emphasise the need to only use sleeping medicines where clinically indicated for short periods of time, and to remind them of the risks of inappropriate use of these medicines.

Stilnox was the first product containing zolpidem to be marketed in Australia in 2000 and by January 2008, there had been 1032 reports of suspected reactions to zolpidem products registered on the TGA's Adverse Reactions database.

More than two thirds of these reports have been received in the last twelve months and 394 included a mention of abnormal sleep related events including sleep-walking, sleep-eating and sleep driving - 103 reports included mention of sleep driving.

Zolpidem products registered in Australia have the following trade names:

Stilnox and Stilnox CR, Dormizol and Dormizol CR, Stilnoxium CR, Zolpidem Dakota, Zolpidem Hexal, Zolpidem Sandoz, Zolpibell, Zolpidem-DP, Synthon Zolpidem, Zolpixdem-Ac, Somidem, Stildem, Zolpidem Pharmacor, Genrx Zolpidem, Chemmart Zolpidem, TerryWhite Zolpidem and Apo-Zolpidem.