Xanax (Alprazolam) - Summary

XANAX SUMMARY

XANAX®      CIV
alprazolam tablets, USP

XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

XANAX Tablets (alprazolam) 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 XANAX.

XANAX is also indicated for the treatment of panic disorder, with or without agoraphobia.

See all indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Xanax (Alprazolam)

Does oral alprazolam affect ventilation? A randomised, double-blind, placebo-controlled trial. [2009.05]
The respiratory effects of benzodiazepines have been controversial...

Cognitive, psychomotor and actual driving performance in healthy volunteers after immediate and extended release formulations of alprazolam 1 mg. [2007.05]
CONCLUSIONS: The acute impairing effects of alprazolam XR 1 mg on driving and psychomotor functions were generally less, as compared to its immediate-release equivalent, but still of sufficient magnitude to increase the risk of becoming involved in traffic accidents.

Current approaches to the pharmacologic treatment of anxiety disorders. [2007]
Despite their high prevalence, the anxiety disorders are underdiagnosed and undertreated.

Different acute tolerance development to EEG, psychomotor performance and subjective assessment effects after two intermittent oral doses of alprazolam in healthy volunteers. [2007]
BACKGROUND/AIMS: Benzodiazepines (BZDs) are the most effective of the psychotropic drugs in the treatment of anxiety disorders. Tolerance has been reported for the majority of BZDs after chronic administration. However, little attention has been paid to the possibility that tolerance might be present after the intermittent oral administration of BZDs. The objectives of the present study were to assess tolerance development after the administration of two intermittent single oral doses of alprazolam given 15 days apart in healthy volunteers, and to compare the results obtained using measures from different domains: neurophysiological, psychomotor and subjective... CONCLUSIONS: The administration of two single oral doses of alprazolam, 2 weeks apart in healthy volunteers, yielded the same PKs on both occasions, but significant changes were observed in the PD profile. Acute tolerance was observed after the second administration. Two patterns of acute tolerance development were obtained: (1) impairments of psychomotor performance and relative beta-1 activity, and (2) subjective assessments and relative alpha activity. (c) 2007 S. Karger AG, Basel.

Attenuation of the hypothalamic-pituitary-adrenal axis responsivity to the Trier Social Stress Test by the benzodiazepine alprazolam. [2006.11]
Little is known about effects of commonly used anxiolytic drugs on psychologically evoked responses of two major stress systems, the hypothalamic-pituitary-adrenal (HPA) and the sympathetic-adrenal-medullary (SAM) axis. The purpose of the present study was to assess effects of the anxiolytic alprazolam on responses of the HPA and the SAM axes to a standardized psychosocial stress protocol, the Trier Social Stress Test (TSST)...

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Clinical Trials Related to Xanax (Alprazolam)

A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks [Terminated]
The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.

Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 1 mg Extended-release tablets to Pharmacia & Upjohn's Xanax XR 1 mg tablets following a single, oral 3 mg (3 x 1 mg) dose administered under fasting conditions.

Fed Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam Extended-release 3 mg tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered under fed conditions.

Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 3 mg Extended-release tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered under fasting conditions.

A Study to Assess the Long-Term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder [Terminated]
The purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in adolescents with panic disorder.

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PATIENT REVIEWS / RATINGS / COMMENTS

Xanax review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		anxiety related to severe PMS
Dosage & duration:		.5 mg taken prn, usually 2x/day for 3 to 4 days/mont for the period of 2 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		the treatment drastically reduced my anxiety and feelings of stress and panic during my PMS week.
Side effects:		no side effects experienced.
Comments:		i was experiencing severe PMS symptoms - upon further testing, it was found that i had an ovarian cyst and used this treatment for anxiety symptoms until my surgery.

Xanax review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		anxiety
Dosage & duration:		0.5mg taken daily for the period of 4yrs
Other conditions:		diabetes, high blood pressure,osteoporosis
Other drugs taken:		metformin,benicar, norvasc,fosamax
		Reported Results
Benefits:		blood sugar controlled levels around 100-110, blood pressure had been normal ever since i was placed on these b/p medications.xanax was the only one that could prevent anxiety and panic attacks and help me sleep. as for fosamax, i have not had a follow up bone density so i do not know how beneficial it is for treating osteoporosis
Side effects:		since i started taking metformin my weight loss continued (this is unwanted weight loss). initially fosamax gave me severe flu like symptoms
Comments:		metformin 250 mg od, benicar 5 mg od , fosamax 70mg q wk,norvasc 2.5 mg od

Xanax review by 60 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Anxiety
Dosage & duration:		1 mg taken every 8 hours for the period of 5 days
Other conditions:		Post Laser Surgery
Other drugs taken:		none
		Reported Results
Benefits:		First days after surgery were a blur. There was considerable swelling post surgery, and the drug helped me to ignore the way I looked.
Side effects:		I was awake but sort of in a daze. I had plans to do research and reading during my recuperation, but I don't remember doing much of anything for about 5 days.
Comments:		Post laser surgery. I had Fraxel Re:pair laser done. I quit the drug as soon as somebody told me I looked like a Zombie.