11 August 2008

To help prescribers and pharmacists counsel patients concerned about the sleep-related adverse effects associated with zolpidem (Stilnox), the National Prescribing Service Limited (NPS) has today released a position statement on the drug and sleep-related behaviours.

NPS Deputy CEO, Karen Kaye said the position statement explains the background to the TGA’s decision to impose a boxed warning on zolpidem (added in February 2008) and to describe the current place of this hypnotic drug in insomnia therapy.

The paper examines the evidence linking the medicine with bizarre sleep-related behaviours, such as sleepwalking, sleep-eating and sleep-driving. It also outlines treatments for insomnia and guidance for counselling patients, pointing GPs and pharmacists to the NPS Fact Sheet on zolpidem released in February this year.

Ms Kaye reminded prescribers that the many potential causes of insomnia should be addressed before making a treatment decision and that the risks associated with hypnotics generally outweigh any benefits they provide with continous long term use.

“NPS advises that patients should avoid alcohol, other CNS depressants, and higher than recommended doses of zolpidem – as these probably increase the risk of sleep-related events.

“However sleep-related events can occur with therapeutic doses of zolpidem in people without these or other predisposing factors. While these events are rare, they can have serious consequences, so consumers and their prescribers should weigh this up when deciding on how to manage sleep problems,” Ms Kaye said.

Non-drug therapies are recommended as initial treatment for insomnia. These include sleep hygiene principles and stimulus control advice, sleep restriction, cognitive therapy, relaxation therapies, and regular exercise.

NPS advises prescribers to reserve short-acting benzodiazepines (eg, temazepam), zolpidem, or zopiclone for short-term severe insomnia, and for intermittent use in chronic severe insomnia that is unresponsive to non-drug therapies.

“For all hypnotics, use the lowest dose for the shortest time possible (ideally for less than two weeks) and re-evaluate within seven to fourteen days of starting therapy,” Ms Kaye said.

The TGA recommends limiting use of zolpidem to a maximum of 4 weeks.

The position paper can be read online at the new-look NPS site www.nps.org.au. The NPS website design was updated this week to make searching for the most relevant and up-to-date information about medicines much easier.

The latest edition of NPS RADAR, published online today, carries an excerpt of the position statement to help ensure doctors and pharmacists are aware of the information, and have easy access to it.

ENDS

National Prescribing Service Limited (NPS) is an independent, non-profit organisation for Quality Use of Medicines funded by the Australian Government Department of Health and Ageing.