Alprazolam permits and prescription guidelines

This information has been prepared by Medicines and Poisons Regulation to assist prescribers in understanding policies and procedures associated with obtaining a permit to prescribe alprazolam, which was reclassified as a Schedule 8 poison on 1 February 2014.

The department’s Chief Psychiatrist has endorsed this information.

Alprazolam – indications for use

The approved indications for alprazolam, as listed on the Australian Register of Therapeutic Goods, are:

• anxiety – short-term symptomatic treatment of anxiety, including treatment of anxious patients with some symptoms of depression
• panic disorder – treatment of panic disorder, with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.

Requirements for permits to prescribe alprazolam

Applications for permits to prescribe alprazolam will generally require evidence of recent support from a specialist in a field relevant to the patient’s medical condition.

Alprazolam is indicated for the short-term treatment of anxiety or panic disorder, so support from a psychiatrist will generally be required. Where there are addiction-related issues, support from an addiction medicine specialist will generally be required. Without such evidence, permit applications may be refused.

Please refer to ‘On this site’ for information about Schedule 8 treatment approvals.

Permit applications without specialist support

In the absence of specialist support, the department will issue a permit only for a short-term period. This is to provide prescribers with time to either:

i. cease alprazolam by gradual dose reduction or by changing to another medicine, or
ii. obtain specialist advice in support of ongoing treatment.

Specialists have advised the department that they are unlikely to support ongoing treatment with alprazolam.

Advice from Therapeutic guidelines: psychotropic on benzodiazepine dose reduction and changing from one benzodiazepine to another is available for download.

Where a patient has a history of drug dependence, an applicant will also be required to submit a declaration form to indicate that specific steps have been taken in relation to patient management.

Alprazolam – general information about abuse

Facts related to inappropriate use of alprazolam include the following:

• The high potency and short onset of action of alprazolam make it a preferred medicine for abuse. Alprazolam is the most commonly reported benzodiazepine among Australians who inject drugs who report injection of benzodiazepines.
• Alprazolam is more subject to nonmedical use than other benzodiazepines, and causes a disproportionately high level of serious harm than other benzodiazepines.
• Alprazolam 2 mg tablets are often concurrently prescribed for patients for whom other medical practitioners hold permits to prescribe opioid replacement therapy, without the knowledge or consent of the permit holders, who also may be prescribing longer-acting benzodiazepines (for example, diazepam).
• Alprazolam 2 mg tablets are the subject of the majority of forged prescription reports in Victoria and have a significant street value.
• Alprazolam contributed to 56 deaths in Victoria in 2010, representing 16.6 per cent of total drug-induced or drug-related deaths investigated by the Coroners Court of Victoria in 2010.
• Inappropriately high doses of alprazolam can cause anterograde amnesia, and are associated with anger, aggression, and violent and threatening behaviour, which the subjects do not remember next day.
• Subjects affected by high doses of alprazolam lose inhibition. If they commit crimes while affected, they may be unaware of their surroundings and, when they recover in police cells, may not remember the actions that led to their arrest.

Alprazolam – reasons for rescheduling

Scheduling decisions on medicines are made by the Secretary of the Australian Government Department of Health 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 as follows:

• Alprazolam is associated with increased morbidity and mortality in overdose, with possibly greater toxicity than 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 – that is, for short-term use.
• Submissions stated that there is evidence of abuse of alprazolam and misuse with opioids, with alprazolam being more subject to diversion from licit to illicit use than other benzodiazepines.

It was also noted that listing in Schedule 8 of alprazolam does not restrict its short-term use for the approved indications.

The full record of reasons and the summary of submissions for the rescheduling of alprazolam are available on the Therapeutic Goods Administration website.

Further information

Clinical advice for health practitioners

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

The NPS fact sheet Anxiety disorders – which treatment for what anxiety disorder? (NPS News 65, 2009) provides information on evidence-based treatment strategies for anxiety disorders. The fact sheet is available on the NPS website.

A summary of the Royal Australian and New Zealand College of Psychiatrists (RANZCP) clinical practice guidelines for the treatment of panic disorder and agoraphobia is available on the RANZCP website.

The Royal Australian College of General Practitioners (RACGP) has issued a health alert on rescheduling of alprazolam to a Schedule 8 poison, to provide general practitioners with some management strategies when a patient requests a prescription for alprazolam. The alert is available on the RACGP website.

To obtain clinical advice from addiction medicine consultants, health professionals may phone the Drug and Alcohol Clinical Advisory Service (DACAS).

Withdrawal and dose reduction

DACAS has prepared a fact sheet, Withdrawal from benzodiazepine dependence, for information about benzodiazepine withdrawal in a general practice setting. The fact sheet is available at the DACAS website.

Therapeutic guidelines: psychotropic provides advice on dose reduction and diazepam dose equivalents for benzodiazepines.

Counselling and advice for patients

The RANZCP has developed a guide, Panic disorder and agoraphobia: Australian treatment guide for consumers and carers. The guide is available on the RANZCP website.

For 24-hour confidential drug and alcohol counselling, and treatment information, patients, families and health professionals may phone DirectLine.

Legislative enquiries for health professionals

Health professionals may contact Medicines and Poisons Regulation for further information about:

• legislative requirements for the administration, prescribing and supply of alprazolam
• Schedule 8 permit requirements in relation to alprazolam
• the department’s policy for issuing Schedule 8 permits.