Zolpidem And Quality Use Of Medicines

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Pharmacy / Pharmacist
Article Date: 04 Mar 2008 - 3:00 PDT

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With the addition of a 'boxed warning' in the Product Information (PI) for medicines containing zolpidem, including Stilnox, PSA and the Therapeutic Goods Administration (TGA) believe it is timely for pharmacists to reinforce Quality Use of Medicines messages to ensure consumers use this medicine appropriately.

PSA is contacting members to reinforce information provided by the TGA that has previously been released to healthcare professionals and the public about the use of zolpidem and any other form of sleeping tablets.

The new boxed warning states: '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 TGA's action to apply the boxed warning followed the decision of the National Drugs and Poisons Schedule Committee on 21 February not to restrict access to zolpidem by moving it from Schedule 4 to Schedule 8.

The TGA had referred the status of zolpidem to NDPSC and had been awaiting its decision before taking any additional regulatory steps. This followed other regulatory actions undertaken by the TGA 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 PI and Consumer Medicines Information (CMI) to explicitly warn of certain side-effects.

In accordance with the advice from the TGA and the principles of the Quality Use of Medicines, PSA is passing on the following key messages to members:

- Zolpidem should only be used when needed, and such use should be carefully monitored, managed and reviewed.

- Patients should be provided with sufficient information (including the possibility and nature of potential adverse events) to enable them to use zolpidem wisely and safely.

- Zolpidem should only be used in accordance with approved indications, for as short a period as possible, and with the maximum duration of use limited to four weeks.

Other resources

- Pharmacy Self Care members can access a PDF of the Sleeping Problems Fact Card from this page (member log-in required)

- National Prescribing Service fact sheet on 'Sleeping Tablets'

- For more detailed information on the TGA's regulatory actions regarding zolpidem visit this web page.

Pharmaceutical Society of Australia