Alprazolam to become S8
May 24, 2013
AN interim decision of the
delegate of the Secretary of the
Department of Health and Ageing
will see alprazolam rescheduled as
S8 substance, with a proposed date
for the change of 01 Jan 2014.
According to an update on the
TGA website, the move follows
consideration of a proposal to
reschedule all benzodiazepines
from S4 to S8, which was referred
to the Advisory Committee on
Medicines Scheduling for advice.
The rescheduling of alprazolam
has been a long-running saga,
having been considered in Jun
2010 after the up-scheduling of
flunitrazepam, which was included
in Schedule 8 in Nov 1997 based on
concerns associated with abuse.
At that time the committee said
there was insufficient evidence
to support an S8 restriction for
alprazolam, but in this most recent
review a significant number of
public submissions were received,
some of which urged the schedule
change “due to concerns regarding
abuse of this substance”.
The ACMS recommended the
change for alprazolam, and
also that the scheduling of the
remaining benzodiazepines remains
appropriate.
A recommendation that
benzodiazepines be included in
Appendix D, paragraph 5, has also
been approved on an interim basis.
According to the interim decision,
there has been a rapid increase in
the use of alprazolam compared
with other benzodiazepines, and
evidence of widespread misuse.
Alprazolam “has increased
morbidity and mortality in
overdose with possible increased
toxicity,” and moreover does not
appear to have any additional
therapeutic benefits compared with
any other substance in the class,
the delegate said.
Also, listing in Schedule 8 for
alprazolam does not restrict its
short-term use for the approved
indication, the statement added.
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