Scheduling Of Zolpidem (Stilnox), Australia

The National Drugs and Poisons Schedule Committee (NDPSC) in the planning of zolpidem (in the medical Stilnox) February 2008 at its meeting this week because of concerns related to reports of possible abuse of this substance.

The NDPSC a series of statements to describe personal accounts of adverse events, including the bizarre behaviors sleep and their consequences.

While the NDPSC recognizes the concerns that members of the public have about these adverse events, the members of the Committee concludes that the current Schedule 4 (Prescription Only) zolpidem status remains appropriate.

This concluded the NDPSC agreed that zolpidem does not meet the criteria for a Schedule 8 (Controlled Drug) medicine. Schedule 8 drugs must show a substantial risk of abuse, dependence or abuse for illegal purposes. There was no convincing evidence presented that the NDPSC the abuse potential zolpidem requires it publishes.

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

NDSPSC also pointed out that the TGA has several appropriate regulatory action, and is currently continuing its assessment of Australian and international data on the safety of zolpidem. The NDPSC be a brief observation on the subject in the coming months.

In accordance with the NDPSC practice and statutory requirements, a record of the reasons for this and other scheduling decisions in the February 2008 meeting will be open to the public on the NDPSC site on 4 April 2008.

The National Drugs and Poisons Schedule Committee

The NDPSC is a statutory committee under the Therapeutic Goods Act 1989. It is responsible for establishing the classification and scheduling of substances for inclusion in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), along with other functions. The NDPSC has a broad spectrum of experts and professional members, with memberships from the jurisdiction of the Commonwealth, states and territories and New Zealand.

The NDPSC is required to publish a notice in the Official Journal before and after each session, which included an invitation to the public to give advice.

Scheduling and coordination procedures and the questions of NDPSC must take into account when making a decision, in the law and related regulations.

The NDPSC decisions are made by a majority of members present and voting at a meeting NDPSC and needs a majority of the jurisdiction of the members present and voting. There are eleven members from the jurisdiction of the community (1), states and territories (8) and New Zealand (2). However, only a representative of one of New Zealand as a member of the judiciary, for the purposes of voting.

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

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