Riyadh, March 3, 2008 – The Australian Therapeutic Goods Administration (TGA), that country’s equivalent to the Saudi Food and Drug Authority (SFDA), announce new, stronger safety warning for the sleep medication zolpidem. This drug is sold as Stilnox or Zolpigen in Saudi Arabia.

The new safety warning is the result of reports of bizarre and sometimes dangerous sleep disorders in patients who have received the drug. The TGA notes that through January 4, 2008 that the agency’s adverse drug reaction database contained 1,032 reports of suspected adverse drug events associated with the use of zolpidem. Of these, 394 reports mentioned abnormal sleep-related events such as sleep walking sleep eating and sleep driving and 103 reports (10% of all reports) included the mention of sleep driving.

In response to these adverse event reports, significant changes were made to the professional product summaries and consumer information for products containing zolpidem. The following warning will appear in bold letters highlighted by a box:

The new consumer information includes warnings about other possible adverse effects with the use of zolpidem. These include unexpected changes in behavior; rage reactions; worsened insomnia; confusion; agitation; hallucinations; and other forms of unwanted behavior.

Reports to the TGA also include sleep walking and sleep driving. There were also reports of preparing and eating food, making phone calls or having sexual intercourse. People experiencing these effects have had no memory of the events.

The full text of the TGA announcement can be found on the Internet at: .

The actions of the TGA concerning zolpidem follow a similar warning that included all sleeping medications issued by the U.S. Food and Drug Administration (FDA) on March 14, 2007. In addition to warning about potentially dangerous complex sleep related behaviors the U.S. authorities also warned of the possibility of anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), that can occur as early as the first time the product is taken.

The complete text of the FDA’s warning can be found on the agency’s Web site at: .


ACTIONS THAT HEALTHCARE PROFESSIONALS AND PUBLIC SHOULD FOLLOW:

· Physicians and patients should beware that dependency is possible with the use of zolpidem and the drug should only be used for shortest period of time possible.

· Physicians and patients should be aware that the use of zolpidem in combination with alcohol causes additive psychomotor impairment.

· Physicians and patients should be aware that the use of zolpidem in combination with other central nervous system (CNS) depressants causes additive psychomotor impairment.

REPORT ADVERSE DRUG REACTIONS TO THE SAUDI FDA

The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at .