Alprazolam to become Schedule 8: Information for prescribers

2014-02-01

From 1 February 2014, alprazolam will be rescheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) to Schedule 8. The purpose of this document is to inform prescribers of the regulatory requirements for prescribing alprazolam and the clinical guidelines and patient guides available for the treatment of anxiety disorders. This document has been endorsed by the Department of Health’s Chief Psychiatrist.


Reasons for rescheduling

Scheduling decisions on medicines are made by the Secretary of the Commonwealth Department of Health and Ageing and adopted nationally, after consideration of recommendations from an advisory committee and submissions through a public consultation process. In summary, the reasons for the decision to reschedule alprazolam to Schedule 8 were:

• Alprazolam is associated with increased morbidity and mortality in overdose with possible increased toxicity compared with other benzodiazepines.

• Alprazolam does not appear to have any additional therapeutic benefits compared with any other benzodiazepine.

• Submissions suggested that there has been a rapid increase in use of alprazolam compared with other benzodiazepines and that there is evidence of widespread misuse.

• There is concern that the current pack size of alprazolam is inappropriate for the approved indications, i.e. for short-term use.

• Submissions stated that there is evidence of abuse of alprazolam and misuse with opioids, with it being more subject to diversion from licit to illicit use than with other benzodiazepines.

It was noted that listing in Schedule 8 of alprazolam does not restrict its short-term use for the approved indications. The full record of reasons plus the summary of submissions for the rescheduling of alprazolam are available on the Therapeutic Goods Administration (TGA) website.

Clinical advice for health professionals

The National Prescribing Service (NPS) recommends that the use of benzodiazepines, including alprazolam, is not recommended as first line treatment for anxiety or panic disorder. Benzodiazepine use should be reserved to the short-term for patients who have not responded to at least two other therapies (e.g. psychological therapy, antidepressants).

Full Article.