Alprazolam (Alprazolam) - Summary

ALPRAZOLAM SUMMARY

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.

See all Alprazolam indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Alprazolam

Comparison of alprazolam versus captopril in high blood pressure: a randomized controlled trial. [2011.08]
CONCLUSION: A significant association exists between the level of BP and anxiety in hypertensive ED patients. Alprazolam is as effective as captopril in lowering BP in ED patients with an initial SBP > 160 mmHg.

Efficacy of alprazolam sublingual tablets in the treatment of the acute phase of panic disorders. [2011.03]
CONCLUSIONS: Alprazolam has been demonstrated to have efficacy, safety and good tolerability in the treatment of the acute phase of panic disorder, the sublingual tablets showing some comparative advantages.

The efficacy and safety of alprazolam versus other benzodiazepines in the treatment of panic disorder. [2011]
We performed a meta-analysis of all single- or double-blind, randomized controlled trials comparing alprazolam to another benzodiazepine in the treatment of adult patients meeting the Diagnostic and Statistical Manual of Mental Disorders, Third or Fourth Edition, criteria for panic disorder or agoraphobia with panic attacks...

The effects of alprazolam on tinnitus: a cross-over randomized clinical trial. [2009.11]
CONCLUSIONS: These results suggest that although alprazolam did not improve the THI score or sensation level of loudness significantly, it has a desirable effect on VAS. Further work is needed to determine the beneficial effects of alprazolam in distressed or depressed patients.

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

more studies >>

Clinical Trials Related to Alprazolam

Staccato™ Alprazolam for Inhalation in Panic Attack [Completed]
We are developing Staccato™ 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.

Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation [Not yet recruiting]
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.

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.

more trials >>

Reports of Suspected Alprazolam Side Effects

Completed Suicide (524),  Cardiac Arrest (384),  Respiratory Arrest (382),  Toxicity TO Various Agents (341),  Drug Abuse (239),  Cardio-Respiratory Arrest (229),  Death (209),  Poisoning (154),  Drug Ineffective (113),  Intentional Drug Misuse (99), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Alprazolam review by 49 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		anxiety
Dosage & duration:		.5mg once a day taken up to once a day for the period of over two years
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		In low doses, this drug does exactly what it says it does - reduces symptons of anxiety. It is especially helpful for very anxiety-producing situations such as speaking in front of groups, flying, and going into crowded places. The drug produces a feeling of being more relaxed, and in extremely high anxiety situations (flying), if I take the full dose of .5 mg, it will sleep and wake up with no residual effects.
Side effects:		Drowsiness, if I take the high end of the prescribed dose, but in this case, that's the desired effect.
Comments:		I can take up to .5 mg / day as needed. I usually take .25 mg to .5 mg / day.

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 25 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Panic attacks
Dosage & duration:		1mg taken 3 times a day for the period of nearly 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		It was very good in controlling the panic attacks. Before taking it I was even unable to drive my car down the road without having a panic attack. I worked liked magic from the very first dose. I could resume to being close to feeling like a normal person again. It worked well for panic attack prevention.
Side effects:		There were no real side effects other than a dry mouth. I still suffered from some anxiety symtoms such as feeling a bit nervous restless, sometimes had trouble sleeping. If I drank alcohol at the same time in small amounts, I felt even better and seemed to have no bad feeling at all but that was short lived, and as I found out later on also dangerous. And Just don"t ever stop taking it suddenly. Thats also very dangerous.
Comments:		The treatment was to take three 1 mg tablet a day, with food. The trouble was that I became very reliant on the medication and felt I needed to keep taking it. Then one day I decided to quit and I just stopped taking it. I don"t know why I did not slowly wean myself off over a couple of weeks. Over the course of the next three days I never got out of the house I was sick, shaking uncontrollably, having hallucinations both audial and visual I thought I was going to die. I felt like hell. A friend found me and took me to the doctor. It was the worst feeling I have ever felt in my life it was the withdrawal symptoms from the drug. All I needed to do was take more, but I felt to afraid. To this day I cant tell you why I just could"nt think straight.