INDICATIONS AND USAGEAlprazolam tablets are indicated for the management of anxiety
disorder (a condition corresponding most closely to the APA Diagnostic and
Statistical Manual (DSM-III-R) diagnosis of generalized anxiety disorder) or the
short-term relief of symptoms of anxiety. Anxiety or tension associated with the
stress of everyday life usually does not require treatment with an
anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive
anxiety and worry (apprehensive expectation) about two or more life
circumstances, for a period of six months or longer, during which the person has
been bothered more days than not by these concerns. At least 6 of the following
18 symptoms are often present in these patients: Motor
Tension (trembling, twitching, or feeling shaky; muscle tension, aches,
or soreness; restlessness; easy fatigability); Autonomic
Hyperactivity (shortness of breath or smothering sensations; palpitations
or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness
or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or
chills; frequent urination; trouble swallowing or lump in throat); Vigilance and Scanning (feeling keyed up or on edge;
exaggerated startle response; difficulty concentrating or mind going blank
because of anxiety; trouble falling or staying asleep; irritability). These
symptoms must not be secondary to another psychiatric disorder or caused by some
organic factor.
Anxiety associated with depression is responsive to alprazolam.
Alprazolam tablets are also indicated for the treatment of panic disorder,
with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses
corresponded closely to the DSM-III-R criteria for panic disorder (see CLINICAL STUDIES).
Panic disorder is an illness characterized by recurrent panic attacks. The
panic attacks, at least initially, are unexpected. Later in the course of this
disturbance certain situations, eg, driving a car or being in a crowded place,
may become associated with having a panic attack. These panic attacks are not
triggered by situations in which the person is the focus of others attention
(as in social phobia). The diagnosis requires four such attacks within a four
week period, or one or more attacks followed by at least a month of persistent
fear of having another attack. The panic attacks must be characterized by at
least four of the following symptoms: dyspnea or smothering sensations;
dizziness, unsteady feelings, or faintness; palpitations or tachycardia;
trembling or shaking; sweating; choking; nausea or abdominal distress;
depersonalization or derealization; paresthesias; hot flashes or chills; chest
pain or discomfort; fear of dying; fear of going crazy or of doing something
uncontrolled. At least some of the panic attack symptoms must develop suddenly,
and the panic attack symptoms must not be attributed to some know organic
factors. Panic disorder is frequently associated with some symptoms of
agoraphobia.
Demonstrations of the effectiveness of alprazolam by systematic clinical
study are limited to four months duration for anxiety disorder and four to ten
weeks duration for panic disorder; however, patients with panic disorder have
been treated on an open basis for up to eight months without apparent loss of
benefit. The physician should periodically reassess the usefulness of the drug
for the individual patient.