Stilnox not rescheduled, will carry warnings

Simone Roberts

The committee yesterday considered rescheduling Stilnox to S8, making it a controlled substance. But it decided not to restrict access to the drug, instead imposing a boxed warning on product information documents for medicines containing zolpidem.

The move follows reports of bizarre and sometimes dangerous sleep-related behaviours such as sleep-walking and sleep-driving in some users of the drug.

In reaching its decision, the NDPSC said there was no compelling evidence that the abuse potential of the drug required it to be rescheduled.

The NDPSC also noted that the TGA had taken several appropriate regulatory actions and is currently evaluating Australian and international data on the safety of the drug.

The boxed warning reads: "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."

The Pharmaceutical Society of Australia (PSA) welcomed the decision, saying it would reinforce the message to all health care providers to counsel patients appropriately.

"Pharmacists play a vital role in ensuring all medicines are used appropriately, not just zolpidem, and it is integral to their role to counsel consumers in potential adverse effects from medicines," said the society's spokesman Aaron Hall.

"Pharmacists are already playing an important role in protecting consumer safety and will work to ensure consumers are appropriately informed about the issues associated with zolpidem and other sleeping medicines."