To discontinue treatment in patients taking XANAX, the dosage should be reduced slowly in
keeping with good medical practice. It is suggested that the daily dosage of XANAX be
decreased by no more than 0.5 mg every three days (see DOSAGE AND
ADMINISTRATION). Some patients may benefit from an even slower dosage reduction. In a
controlled postmarketing discontinuation study of panic disorder patients which compared
this recommended taper schedule with a slower taper schedule, no difference was observed
between the groups in the proportion of patients who tapered to zero dose; however, the
slower schedule was associated with a reduction in symptoms associated with a withdrawal
syndrome.
As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle
spasticity, sleep disturbances, hallucinations and other adverse behavioral effects such as
agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In
many of the spontaneous case reports of adverse behavioral effects, patients were receiving
other CNS drugs concomitantly and/or were described as having underlying psychiatric
conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated
published reports involving small numbers of patients have suggested that patients who have
borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or
substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive
thoughts have been reported during discontinuation of alprazolam in patients with
posttraumatic stress disorder.
Post Introduction Reports: Various adverse drug reactions have been reported in association
with the use of XANAX since market introduction. The majority of these reactions were
reported through the medical event voluntary reporting system. Because of the spontaneous
nature of the reporting of medical events and the lack of controls, a causal relationship to the
use of XANAX cannot be readily determined. Reported events include: gastrointestinal
disorder, hypomania, mania, liver enzyme elevations, hepatitis, hepatic failure, Stevens-
Johnson syndrome, angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and
galactorrhea (see PRECAUTIONS).
DRUG ABUSE AND DEPENDENCE
Physical and Psychological Dependence
Withdrawal symptoms similar in character to those noted with sedative/hypnotics and alcohol
have occurred following discontinuance of benzodiazepines, including XANAX. The
symptoms can range from mild dysphoria and insomnia to a major syndrome that may include
abdominal and muscle cramps, vomiting, sweating, tremors and convulsions. Distinguishing
between withdrawal emergent signs and symptoms and the recurrence of illness is often
difficult in patients undergoing dose reduction. The long term strategy for treatment of these
phenomena will vary with their cause and the therapeutic goal. When necessary, immediate
management of withdrawal symptoms requires re-institution of treatment at doses of XANAX
sufficient to suppress symptoms. There have been reports of failure of other benzodiazepines
to fully suppress these withdrawal symptoms. These failures have been attributed to
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Reference ID: 4029640