Tolerability

*Incidence ≥10% and ≥5% higher than placebo from the XANAX prescribing information. Placebo-corrected incidence of additional adverse events meeting this criteria were: constipation (11% vs 4%), increased appetite (10% vs 1%), cognitive impairment (8% vs 1%), weight gain (9% vs 1%), weight loss (6% vs 0%), fatigue (7% vs 5%), and decreased libido (6% vs 4%), XANAX (N=1388) vs XANAX XR (N=531), respectively.

The similarity in study entry criteria, study design, clinical characteristics of the treatment sample, and dose range utilized (1-10 mg, with a mean dose of approximately 5 mg) enabled this qualitative comparison from the prescribing information of XANAX and XANAX XR. The percentages presented above were arrived at by subtracting the placebo adverse events from the XANAX and XANAX XR groups.

Sedation, the primary treatment-emergent adverse event observed in clinical studies, is generally mild to moderate and resolves early in the majority of patients.5,6^†

^†Instruct patients not to drive a vehicle or operate dangerous machinery until they experience how XANAX XR affects them.

Safety

XANAX XR is contraindicated in patients with known sensitivity to this drug or other benzodiazepines, in patients with acute narrow-angle glaucoma, and in patients taking potent CYP3A inhibitors, such as ketoconazole and itraconazole.

Certain adverse clinical events are a direct consequence of physical dependence to alprazolam. These include a spectrum of discontinuation symptoms, the most important being the possibility of seizure.

The most commonly observed adverse events in patients treated with XANAX XR in controlled clinical trials (=5% and at least twice the incidence observed for placebo) were: sedation (45.2% vs 22.6%), somnolence (23.0% vs 6.0%), memory impairment (15.4% vs 6.9%), dysarthria (10.9% vs 2.6%), abnormal coordination (9.4% vs 0.9%), ataxia (7.2% vs 3.2%), and decreased libido (6.0% vs 2.3%).

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