Alprazolam (Alprazolam) - Summary

ALPRAZOLAM SUMMARY

Alprazolam Tablets, USP CIV

Alprazolam is a triazolo analog of the 1, 4 benzodiazepine class of central nervous system-active compounds.

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

Studies support ing 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 attributable to some known 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.

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ALPRAZOLAM NEWS HIGHLIGHTS

Published Studies Related to Alprazolam

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)...

The benzodiazepine alprazolam dissociates contextual fear from cued fear in humans as assessed by fear-potentiated startle. [2006.10.01]
BACKGROUND: The startle reflex is potentiated by aversive states. It has been proposed that phasic startle potentiation to a threat cue and sustained startle potentiation to contextual stimuli reflect distinct processes mediated by different brain structures. The present study tested the hypothesis that alprazolam would reduce the sustained startle potentiation to contextual threats but not the startle potentiation to a threat cue... CONCLUSIONS: Startle responses to an explicit threat cue and to an aversive context are psychopharmacologically distinct, suggesting that they may represent functionally dissociable aversive states.

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Clinical Trials Related to Alprazolam

Staccatoâ„¢ Alprazolam for Inhalation in Panic Attack [Completed]
We are developing Staccatoâ„¢ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.

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.

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.

A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety [Completed]
This was a multicenter, open-label, randomized crossover trial comparing two treatments, Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking conventional immediate-release alprazolam tablets for anxiety. The trial included five study

visits (four periods of 7 3 - day duration): Screening (Visit 1), Treatment Period 1 (Visit

2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 [telephone visit]). At Visit 1, following screening, eligible subjects continued to take their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking alprazolam in accordance with the treatment sequence to which they were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference Questionnaire, and a physical examination and clinical laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own conventional alprazolam.

The site made a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's

health status.

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.

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ALPRAZOLAM PATIENT REVIEWS / RATINGS / COMMENTS

Alprazolam review by 23 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Panic disorder, agoraphobia
Dosage & duration:		0.25 (dosage frequency: as needed) for the period of 1 month
Other conditions:		Insomnia, high blood pressure, agora
Other drugs taken:		None
		Reported Results
Benefits:		Helped me be able to leave the house for the first time in months, quickly reduced my anxiety and I didn't have any attacks.
Side effects:		Barely any despite some slight confusion.
Comments:		This medication (and other benzodiazepines) has gotten a bad reputation because some irresponsible people have ruined it for those that actually need it. If people would take this drug as prescribed, there would not be as many problems and it wouldn't carry the stigma it does now. I started having panic attacks when I turned 21, and the condition soon worsened into full-blown panic disorder. A year later, I couldn't hold down a job and was agoraphobic. I tried counseling and medications like Zoloft and Lexapro. The side effects from those made me feel worse than I did just not taking them. Finally my doctor decided to put me on Alprazolam as-needed. It has been a life-saver for me. I would take the lowest dose (0.25 mg), and be able to leave my house for the first time in months. I visited friends, went to restaurants, and did everything I used to do before my disorder. I finally felt like I had my life back. I would take one whenever I anticipated a situation where I could have an attack, or when I felt one coming on already. Sometimes I didn't even need all of the 0.25 mg and could break it in half. Too many people abuse this medication by upping their dosage without a doctor's consent or using it when they don't need to, and now you are almost treated like a criminal at some pharmacies and doctor's offices when they learn you are taking it because they think you are a druggie. I *much* prefer this medication over any of the SSRIs, which have horrible side effects. I felt like a zombie on those medications, had no sex drive at all, and didn't have any energy whatsoever. The doctors tell you those side effects will go away with use, but for days to even weeks you feel 10 times worse than you did before. It's just not worth it. 0.25 mg of Alprazolam as-needed for anxiety has helped me get my life back on track and really helped save me from spending days and nights locked away in my house. I highly recommend this medication for responsible people who just need something in a crutch and don't want to go on long-term SSRIs that leave you feeling drained and lifeless. Yes, counseling and therapy are a better alternative to medication, but the problem is always finding a *good* counselor, and sometimes even then, they just don't work. I have seen 3 counselors and all of them have failed to help me with anything, all I did was waste a $20 copay each visit to have them tell me things that sounded like they came from an inspirational booklet. Taken *as* prescribed or as-needed, this drug is wonderful.

Alprazolam review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		anxiety
Dosage & duration:		.5 mg taken 3x daily for the period of 6 months
Other conditions:		depression
Other drugs taken:		none
		Reported Results
Benefits:		I found that episodes of anxiety were less frequent and less severe. I was not as edgy or easily startled.
Side effects:		During the day, there were times I was drowsy and did not feel it was safe to take the medication, as I had to be alert for driving or for concentrating at work.
Comments:		Doctor monitored, and when there was improvement sustained over time, I "weaned" off the drug and have a prescription where I can take small doses "as needed."

Alprazolam review by 70 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Anxiety, Panic Attck, Nervousness
Dosage & duration:		0.5 mg taken in the beginning i took 0.25 mg for the period of For 8 years
Other conditions:		Blood Pressure, Mildly Diabetic
Other drugs taken:		Zestril, Glucophage, Amlodipine (Novasc)
		Reported Results
Benefits:		I experienced Xannax more effective for anxiety and panic attacks.
Side effects:		I didn't feel any alarming side effects from this medication even after using for over 8 years. The feeling of dependency doesn't bother as we are sometimes addict of certain foods also.
Comments:		First I experienced the state of anxiety and panic at the age of 20. Starting with Librium I was successful to managed and control my mood and over sensitive nature. Regular exercise, food and lively hobbies helped to relieve me form all sedative and tranquilizers. It was, probably, job related stress and tension what triggered the state of anxiety and panic. Now the above-mentioned medications are helping to perform my activities, mostly as a normal person.