Medicine regulator places boxed warning on Stilnox
Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has today imposed a boxed warning in the product information documents for medicines containing zolpidem, including Stilnox.
This builds on other actions by the TGA to strengthen warnings about the potential side effects of zolpidem, following reports of bizarre and sometimes dangerous sleep related behaviours such as sleep walking and sleep driving in some users of the drug.
These behaviours may have serious consequences for users of zolpidem, and it is important that healthcare professionals and the public are advised about these side effects.
The action to apply a boxed warning follows the decision today 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.
There is a need to reinforce information previously released by the TGA reminding healthcare professionals and the public of the need for careful prescribing and use of zolpidem and any other form of sleeping tablets.
These medicines are indicated ONLY for short term use, and should not be used with alcohol. Caution should be exercised using any sleeping medicines and particularly in patients taking other medicines that act on the brain, such as antidepressants. 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 medicines, 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.
The TGA has arranged an urgent meeting with the National Prescribing Service to discuss development of additional educational materials for prescribers further emphasising 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.
Media contact: Kay McNiece, TGA Media Adviser, 0412 132 585
The first product containing zolpidem to be marketed in Australia was Stilnox. It was registered in Australia in1997 but not marketed here until 2000. Up to 4 January 2008, 1032 reports of suspected reactions to zolpidem products have been entered into the TGA's Adverse Reactions database. More than two thirds of these reports (687) have been received in the last twelve months. 394 of the 1032 reports included mention of abnormal sleep related events including sleep-walking, sleep-eating and sleep driving. 103 reports (10% of all reports) included mention of sleep driving.
A boxed warning is a succinct warning statement printed at the start of the approved product information, designed to alert prescribers to an important safety issue with a medicine. The warning is highlighted by a bold black surround or "box". The wording of the boxed warning for zolpidem is "Zolpidem may be associated with potentially dangerous complex sleep- related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to four weeks maximum under close medical supervision."
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
- Synthon Zolpidem
- Zolpidem Pharmacor
- Genrx Zolpidem
- Chemmart Zolpidem
- TerryWhite Zolpidem