Scheduling Of Zolpidem (Stilnox), Australia

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Pharmacy / Pharmacist;  Pharma Industry / Biotech Industry
Article Date: 22 Feb 2008 - 13:00 PDT

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The National Drugs and Poisons Schedule Committee (NDPSC) considered the scheduling of zolpidem (contained in the medicine Stilnox) at its February 2008 meeting, held this week, because of concerns relating to reports of potential abuse of this substance.

The NDPSC also considered a number of submissions describing personal accounts of adverse events, including bizarre sleep behaviours and their consequences.

While the NDPSC acknowledges the concerns that members of the public have raised regarding these adverse events, members of Committee concluded that the current Schedule 4 (Prescription Only) status of zolpidem remains appropriate.

In reaching this conclusion, the NDPSC agreed that zolpidem does not meet the criteria for a Schedule 8 (Controlled Drug) medicine. Schedule 8 medicines must demonstrate a substantial risk of abuse, dependence or misuse for illegal purposes. There was no compelling evidence presented to the NDPSC that the abuse potential of zolpidem requires it to be rescheduled.

The NDPSC noted that zolpidem is only available by prescription under the supervision of a medical practitioner and its use should be carefully monitored by the prescribing doctor. It is only indicated for short-term use and should not be used with alcohol. Zolpidem should be used with caution if taking other central nervous system medications, such as antidepressants, under close medical supervision.

The NDSPSC also noted that the TGA has taken several appropriate regulatory actions and is currently continuing its evaluation of Australian and international data on the safety of zolpidem. The NDPSC will be keeping a watching brief on this matter over the coming months.

In accordance with the NDPSC's practice and statutory requirements, a record of reasons for this and other scheduling decisions made at the February 2008 meeting will be publicly available on the NDPSC website on 4 April 2008.

The National Drugs and Poisons Schedule Committee

The NDPSC is a statutory committee established under the Therapeutic Goods Act 1989. It is responsible for determining the classification and scheduling of substances for inclusion in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), together with other related functions. The NDPSC has a wide range of expert and professional members, with jurisdictional memberships from the Commonwealth, States and Territories and New Zealand.

The NDPSC is required to publish a notice in the Gazette before and after each meeting, which includes an invitation to the public to make submissions.

Scheduling and voting procedures, and the issues the NDPSC must take into account in reaching a decision, are set out in the Act and its associated regulations.

Decisions of the NDPSC are made by a majority of the members present and voting at a NDPSC meeting and must include a majority of the jurisdictional members present and voting. There are eleven jurisdictional members comprising of the Commonwealth (1), states and territories (8) and New Zealand (2). However, only one New Zealand representative is counted as a jurisdictional member for the purposes of voting.

As part of its statutory obligations, the NDPSC publishes records of reasons for its scheduling decisions. This record is published on the NDPSC website approximately six weeks after each meeting. The record of reasons for the February 2008 NDPSC Meeting will be released around 4 April 2008 and can be found here.

http://www.tga.gov.au