Alprazolam

What is Alprazolam?

  • Alprazolam is an antianxiety drug that is used in treatment of panic and anxiety disorders.

Alprazolam generic and brand name

  • The drug is available under generic name Alprazolam and various brand names such as Alprax, Alzam, Alprocontin, Alzolam, Anzilum, Niravam, Tranax, Trika, Xycalm, Xanax, Xanor, Zolam and Zopax.
  • Initially Alprazolam is developed by pharmaceutical company Upjohn.
  • Pfizer Pharmaceuticals is responsible for its manufacturing and distribution.

What is the source of the drug (natural or synthetic)?

  • Alprazolam is a synthetic (man-made) pharmaceutical psychoactive

Why Alprazolam prescribed?

  • Alprazolam plays a key role in the treatment of anxiety disorders such as Social anxiety disorder (SAD) and Generalised anxiety disorder (GAD).
  • It is also prescribed for the treatment of anxiety with co-morbid depression.
  • The medication is also prescribed by FDA for the treatment of the panic disorders with or without Agoraphobia (fear in situations from which escape might be difficult).
  • It may be used to treat the instance of hypersomnia and co-morbid sleep deficits.
  • Alprazolam is also prescribed in combination with other drugs to treat chemotherapy induced nausea and vomiting.

Pharmacophore structure: Information about the chemical structure of the drug

Alprazolam chemically belongs to the class of organic compounds which are known as Benzodiazepines characterized by benzene ring fused to a 1, 4-azepine. The detailed chemical classification of Alprazolam is described below:

Kingdom Organic compounds
Super Class Organoheterocyclic compounds
Class Benzodiazepines
Sub Class 1,4-benzodiazepines
Direct Parent 1,4-benzodiazepines

Chemical information of the drug

  • Alprazolam is available as triazolo analog of the 1, 4-benzodiazepine of central nervous system-active compound.
  • It is a synthetic pharmaceutical aromatic heteropolycyclic compound with a molecular formula C17H13ClN4.
  • The molecular weight of the Alprazolam is 765 g/mol.
  • Chemically, Alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4, 3-α] [1, 4] benzodiazepine.
  • Alprazolam is white and crystalline powder and has water solubility of 0324 mg/mL.
  • Alprazolam is freely soluble in chloroform and dichloromethane, sparingly soluble in acetone, soluble in methanol and ethanol, slightly soluble in ethyl acetate whereas insoluble in water at physiological pH.
  • The melting point of Alprazolam is 228-229.5°

What is the available strength of Alprazolam?

  • Alprazolam is available in immediate release tablet, extended release tablet and orally disintegrating tablet as well as in oral suspensions form for oral administration with food (for oral solution) or without food.
  • Alprazolam IR (immediate release) tablets are available in different strength of 0.25mg, 0.5mg, 1mg and 2mg.
  • Alprazolam IR tablets contain Alprazolam as active ingredient and lactose, docusate sodium, cellulose, corn starch, magnesium stearate, silicon dioxide and sodium benzonate as inactive ingredients. In addition, 0.5 mg tablet contain FD&C Yellow no.6 and 1mg tablet contain FD&C Blue no.2.
  • 25 mg: white in color, ovoid shaped imprinted with “XANAX 0.25”.
  • 5 mg: peach color, ovoid shaped imprinted with “XANAX 0.5”.
  • 1 mg: blue in color, ovoid shaped imprinted with “XANAX 1.0”.
  • 2 mg: white in color, ovoid shaped imprinted with “XANAX” on one side and “2” on another side.
  • Alprazolam XR (extended release) tablets are available in different strength of 0.5mg, 1mg, 2mg and 3mg.
  • Alprazolam XR tablets contain Alprazolam as active ingredient and lactose, magnesium stearate, colloidal silicon dioxide and hypromellose as inactive ingredients. In addition 1 mg and 3 mg tablet contain FD&C Yellow no.10 and 2mg and 3 mg tablet contain FD&C Blue no.2.
  • 5 mg: white in color, pentagonal shaped imprinted with “X” on one side and “0.5” on another side.
  • 0 mg: yellow in color, square shaped imprinted with “X” on one side and “1” on another side.
  • 0 mg: blue in color, round shaped imprinted with “X” on one side and “2” on another side.
  • 0 mg: green in color, triangular shaped imprinted with “X” on one side and “3” on another side.
  • Alprazolam OD (orally disintegrating) tablets are available in different strength of 0.25mg, 0.5mg, 1mg and 2mg.
  • Alprazolam OD tablets contain Alprazolam as active ingredient and magnesium stearate, colloidal silicon dioxide, corn starch, crospovidone, mannitol, methacrylic acid copolymer, microcrystalline cellulose, sucralose, sucrose and orange flavour as inactive ingredients. In addition, 0.25 mg and 0.5 mg tablet contain yellow iron oxide.
  • 25 mg: yellow in color, round shaped, orange flavoured, scored and imprinted with “SP 321” on one side and “0.25” on scored side.
  • 5 mg: yellow in color, round shaped, orange flavoured, scored and imprinted with “SP 322” on one side and “0.5” on scored side.
  • 0 mg: white in color, round shaped, orange flavoured, scored and imprinted with “SP 323” on one side and “1” on scored side.
  • 0 mg: white in color, round shaped orange flavoured, scored and imprinted with “SP 324” on one side and “2” on scored side.
  • Alprazolam concentrated oral solution is golden-yellow in color and available in strength of 75 mg/mL and 1 mg/mL for oral administration.
  • Alprazolam concentrated oral solution contain Alprazolam as active ingredient and succinic acid, succinic acid disodium salt, propylene glycol and water as an inactive ingredients.

How Alprazolam works

  • Alprazolam, a benzodiazepine, non-specifically binds with the benzodiazepine receptors BNZ1 and BNZ2.
  • BNZ1 mediates the sleep while BNZ2 affects the muscle relaxation, motor coordination, anticonvulsant activity and memory.
  • Exact mechanism of action is not fully understood but it is believed that benzodiazepine receptor is coupled to gamma-aminobutyric acid-A (GABAA) receptor.
  • The benzodiazepine receptor locks the gamma-aminobutyric acid-A (GABAA) receptor into a confirmation which has much higher affinity for GABA.
  • GABA is inhibitory neurotransmitter in central nervous system which opens chloride channels, causing an influx of Cl ions.
  • Binding of GABA to GABAA receptor increases the frequency of opening of the related chloride ion channels and hyperpolarize the neurons resulting in the prevention of further excitation of the cell.
  • Stimulation of GABA receptor in peripheral nervous system may cause vasodilation, decrease cardiac contractility and enhance perfusion.

Recommended doses of Alprazolam

  • The prescribed dose of Alprazolam varies depending upon the age and diseased state of the patient.

Adult dose:

  • Anxiety disorder

Immediate-release and orally disintegrating tablets, oral suspension

  • Initial dose: 0.25-0.5mg thrice a day orally for 3-4 days, progressively enhance the dose in every 3-4 days.
  • Maintenance dose: up to 4 mg daily in divided doses orally.
  • Panic disorder

Immediate-release and orally disintegrating tablets

  • Initial dose: 0.5mg thrice a day orally. If required, progressively enhance the dose in every 3-4 days.
  • Maintenance dose: 1 to 10mg daily in divided doses.

Extended-release tablets

  • Initial dose: 0.5-1.0mg once a day orally. If required, progressively enhance the dose in every 3-4 days.
  • Maintenance dose: 1 to 10mg once a day orally.
  • Depression

Immediate-release and orally disintegrating tablets, oral suspension

  • Initial dose: 0.5mg thrice a day orally, progressively enhances the dose in every 3-4 days.
  • Maintenance dose: up to 3mg (maximum 4.5mg) daily in divided doses orally.

Geriatric dose:

  • Anxiety disorder

Immediate-release and orally disintegrating tablets, oral suspension

  • 25mg twice or thrice a day orally. No need to increase the dose.
  • Panic disorder

Immediate-release and orally disintegrating tablets

  • 25mg twice or thrice a day orally.

Extended-release tablets

  • 5mg twice or once a day orally.
  • Depression

Immediate-release and orally disintegrating tablets, oral suspension

  • 25mg twice or thrice a day orally. No need to increase the dose.
  • In case of hepatic and renal impairment, the dosing recommendations are as follows:
  • Dose in hepatic impairment

Immediate-release and orally disintegrating tablets, oral suspension

  • 25mg twice or thrice a day orally. Dose may be regularly increased if required.

Extended-release tablets

  • 5mg twice or once a day orally. Dose may be regularly increased if required.
  • Dose in renal impairment: Caution should be taken in case of renal dysfunction.

When should I discontinue, withhold or modify the dose of Alprazolam?

  • The usual dosing of the drug may vary depending upon the efficiency and side effects of the drug in a particular individual.
  • Do not use the medicine if you are hypersensitive or allergic to any of the ingredients of Alprazolam.
  • Alprazolam is not used in patients with narrow-angle glaucoma, asthma, bronchitis, emphysema, chronic obstructive pulmonary disorder or other breathing problem.
  • Use of Alprazolam with Ketaconazole and Itraconzole is contraindicated because it may drastically impair the oxidative metabolism mediated by cytochrome P450 3A.
  • The drug may be used with excessive caution in patients with myasthenia gravis.
  • Alprazolam is contraindicated with the medication of mental illness, chronic pain and seizures.
  • Alprazolam is also not used with antidepressants (Voriconazole, Imipramine and Nefazodone), antifungals (Fluconazole, Posaconazole or Voriconazole), and antihistamines and ergotamines (Cafergot, Cafatine and Wigraine).
  • Use of Alprazolam may also be contraindicated with the selective serotonin reuptake inhinitor such as Sertraline, Fluvoxamine, Paroxetine and Fluoxetine.
  • Use of sleeping pills, oral contraceptives (it increases maximum plasma concentration by 18% and half-life by 29% and decreases clearance by 22%) and sedatives may be contraindicated with Alprazolam medication.
  • Geriatric patients are more sensitive to the effect of Alprazolam due to higher plasma concentration and reduced clearance. Hence, low dose should be exercised to prevent the development of ataxia and oversedation.

What are the pharmacokinetic properties of the drug?

  • Pharmacokinetic studies suggested that after oral administration, Alprazolam is absorbed in gastrointestinal tract and has a bio-availability of approximately 90%.
  • Following absorption, the majority (80%) of the drug is bound to plasma proteins primarily with
  • It has been observed that following a 0.5-3 mg dose of Alprazolam, maximum (or peak) plasma concentration (8 – 37ng/ml) is achieved in 90-120 minutes in the fasted state.
  • The drug is largely metabolized in liver primarily by cytochrome P450 3A4 (CYP3A4) and hydroxylated into α- hydroxyalprazolam and 4-hydroxyalprazolam.
  • The average median half-life of Alprazolam is 2 (ranges from 6.3 to 26.9) hours.
  • Alprazolam and its metabolites (α- hydroxyalprazolam and 4-hydroxyalprazolam) are mainly excreted in the urine as glucuronides. Uncharged drug is also present in urine in less amount.
  • The average steady state volume of distribution of the Alprazolam is approximately 9-1.2 L/kg.

Which pregnancy category (A; B; C; D; X) has been assigned to Alprazolam?

  • The Alprazolam is classified by US FDA pregnancy category: D
  • There are positive evidences of human fetal risk based on adverse reaction data from investigational and marketing experience or studies in human.
  • Alprazolam in pregnant women is contraindicated and recommended only when benefit justifies the risk.
  • Laboratory animal studies have revealed that the Alprazolam crosses the placenta and show adverse effect on fetus.
  • It may cause neonatal flaccidity and respiratory problems in newborns.
  • Studies support the excretion of the benzodiazepines drugs including Alprazolam into animal milk as well as in human milk. Therefore, breast-feeding is not recommended.
  • Despite these facts caution should be exercised when taking Alprazolam.

How to use the drug?

  • Alprazolam is available in extended-release tablets, orally disintegrating tablets and oral concentrated solution form for oral administration.
  • Alprazolam tablet is taken by mouth with or without food while oral solution is taken with liquid or semi-solid food such as water, juice or applesauce.
  • Oral solution is mixed with liquid or semi-solid food and used completely, do not store for future use.
  • Alprazolam tablets should not be chewed, split or crushed. Whole tablet should be swallowed.
  • It is advisable to take one extended-release tablet daily generally in morning.
  • The orally disintegrating tablet and oral solution should be used in divided doses (2-4 times).
  • Orally disintegrating tablet may be taken with or without water.
  • It is also recommended to take drug at almost the same time every day.
  • Follow the instructions carefully as directed on prescription leaflet and take Alprazolam exactly as directed.
  • Do not change the dose of the drug as prescribed by your doctor as the dosage is based on patient medical condition, treatment responses and usage with other drugs.

How to store the drug?

  • Alprazolam is stored at 25°C (77°F) and excursion permitted to 15-30°C (59-86°F).
  • Store the medicine away from light and moisture.
  • Medicine should not be stored in the bathroom.
  • The drug should be kept away from children and pets.

How to dispose the medicine?

  • Throw away unused and opened, outdated or no longer used container.
  • Also dispose the old medicine after the expiration date.
  • Alprazolam should not be disposed in the household garbage, sink or in wastewater.
  • Consult your pharmacist or local waste disposal company for proper disposal.

Does Alprazolam has approval from government / FDA /or any other related agencies?

  • Alprazolam was approved in October, 1981 by U.S. Food and Drug Administration for the treatment of Anxiety disorder.
  • Alprazolam was also approved for the treatment of panic disorders by U.S. FDA in late 1990s.
  • Alprazolam oral solution was approved on 31, October1993.
  • Alprazolam extended release tablet was approved in January, 2003 and orally disintegrated tablet was approved in January, 2005 by FDA.

Other uses of the drug                                                           

  • Alprazolam may also be used to treat the depression, premenstrual syndrome and agoraphobia (fear of open spaces).
  • Alprazolam may also be used for other uses not listed here. It is advisable to ask your doctor or pharmacist for more information.

What special dietary precautions should I follow?

  • Consult your doctor or pharmacist regarding the use of grapefruit products.
  • Alcohol consumption can also enhance some side effects of the drug.

What special precautions should I follow/ what should I avoid while using Alprazolam?

  • Before taking Alprazolam, tell your doctor about your medical history preferentially if you have any kind of lung disease, liver disease or kidney disease.
  • Take advice from your medical health provider if you have any other kind of eye disorder.
  • Alcoholic beverages, grapefruit, or grapefruit juice should be avoided.
  • Avoid skipping the dose and do not suddenly stop the medication of Alprazolam.
  • Consult with your doctor and pharmacist if you are taking any prescription and non-prescription medications or herbal products.
  • Avoid using machinery requiring alertness or clear vision as well as driving because the use of Alprazolam may make you drowsy.
  • Smoking should be avoided during the medication of Alprazolam.
  • Alprazolam should not be used in the individuals less than 18 years.
  • Consult your doctor in case of any query.

Alprazolam side effects

In addition to the associated benefits, Alprazolam also is accompanied with the side effects some of which are more common, others less common whereas some are more serious. It is always recommended to consult a doctor if you encounter any of the side effects.

Most common side effects caused by Alprazolam requiring medical attention are as follows:

  • Clumsiness or unsteadiness
  • Discouragement
  • Drowsiness
  • Feeling sad or empty
  • Light headedness
  • Loss of interest or pleasure
  • Shakiness and unsteady walk
  • Sleepiness
  • Slurred speech
  • Tiredness
  • Trouble in concentrating, speaking and performing routine tasks
  • Sleeplessness
  • Unsteadiness
  • Trembling
  • Problems with muscle control or coordination
  • Unusual tiredness or weakness

Some less common side effects caused by Alprazolam requiring medical attention are as follows:

  • Chest tightness
  • Chills
  • Clay-colored stools
  • Congestion in nose
  • Cough
  • Dark urine
  • Diarrhoea
  • Fever
  • Headache
  • Hyperventilation
  • Irregular heartbeats
  • Lack of ability to move eyes
  • Memory problems
  • Nausea
  • Painful urination
  • Reduction in urine volume
  • Seizures
  • Sense of discomfort or illness
  • Sore throat
  • Stomach or abdominal pain
  • Swollen joints
  • Trouble in swallowing
  • Unpleasant breath odour
  • Vomiting of blood
  • Yellow eyes or skin

There are some adverse effects that fade away while consuming the drug with time. These symptoms do not require any medical attention, but if these symptoms persist immediately contact to your doctor.

More common symptoms of side effects include:

  • Decreased interest in sexual intercourse
  • Difficulty having a bowel movement (stool)
  • Irregular or missed menstrual periods
  • Lack of ability to have or keep an erection
  • Loss in sexual ability, desire, drive, or performance
  • Loss of appetite
  • Stopping of menstrual bleeding
  • Watering of mouth
  • Weight loss

Less common symptoms of side effects include:

  • Bloating in abdomen
  • Change in taste (bad, unusual, or unpleasant (after) taste)
  • Cramps
  • Crusting, blistering, and irritation on skin
  • Double vision
  • Dry, cracked or scaly skin
  • Feeling of warmth
  • Heavy bleeding
  • Itching or reddening of the skin
  • Redness of the face, neck, arms, and occasionally, upper chest
  • Runny nose or sneezing
  • Sudden sweating

Besides these, Alprazolam may also be associated with some other side effects. These include:

  • Cardiovascular effects: tachycardia, hypotension, chest pain.
  • Nervous system effects: confusion, nervousness, depression, insomnia, irritability, dizziness, headache, fatigue, tiredness, syncope, akathisia, vasomotor disturbance, derealisation and paresthesia.
  • Dermatologic effects: dermatitis, sweating and photosensitivity.
  • Gastrointestinal effects: nausea, dry mouth, constipation, vomiting, diarrhoea, increased salivation.
  • Ocular effects: blurred vision, acute worsening of narrow angle glaucoma.
  • Psychiatric effects: depression, hypomania.
  • Hepatic effect: jaundice, elevated bilirubin and hepatic enzyme.
  • Respiratory effects: hyperventilation, upper respiratory infection.
  • Urinogenital effects: menstrual disorders, micturition difficulties, sexual dysfunction, incontinence, hyperlactatemia, gynecomastia and galactorrhea.

 What should I do in case of overdose?

  • If you overdose the drug contact with your doctor or pharmacist for symptomatic and supportive measures.
  • Symptoms of Alprazolam overdose may include muscle weakness, fainting, drowsiness and confusion.

What should I do in case of missed a dose?

  • Take a missed dose as soon as possible.
  • To make up the missed dose, do not take extra medicine.
  • Avoid taking the missed dose if it is about time for your next dose.

Does Alprazolam have any interaction with other drugs?

Alprazolam may interact with other medications, vitamins or herbs. Care should be taken when you are taking these drugs together. This interaction can be harmful or prevent the drug from working well. Some drugs when given concomitantly with Alprazolam can cause serious side effects. These drugs and Alprazolam should not be taken simultaneously. Examples of these drugs include:

Activators or inhibitors of Cytochrome P450 3A (CYP3A)

Metabolism of Alprazolam is primarily carried out by the cytochrome P450 3A (CYP3A).  Therefore, agents or drugs (activators or inhibitors of CYP3A) that interfere with the metabolism via CYP3A may show interaction with Alprazolam.

Inhibitors of CYP3A: Inhibitors of CYP3A bring about inhibition of the metabolism of Alprazolam and other related benzodiazepines and hence cause an increase in their plasma concentration. These include

  • Azole antifungal agents: Ketoconazole and itraconazole. The concomitant use of these drugs with Alprazolam results in an increase in the plasma concentration of Alprazolam approximately 4 fold and 3 fold respectively and hence not recommended.
  • Other azole-type antifungal agents: They are also potent CYP3A inhibitors that inhibit the metabolism of Alprazolam and hence not recommended with Alprazolam.
  • Other inhibitors of CYP3A:
  • Nefazodone: The drug causes an increase in the concentration of Alprazolam by two fold when coadministered with it.
  • Fluvoxamine: Concomitant use of fluvoxamine with Alprazolam decreases the clearance of Alprazolam by 49% thereby doubling its plasma concentration two fold and increasing its half-life by 71%.
  • Cimetidine: Coadministration of cimetidine causes the plasma concentration of Alprazolam to be increased by 86% and half-life by 16%.
  • Erythromycin: The plasma concentration of Alprazolam increases by 1.61 fold when coadministered with erythromycin.

It is therefore recommended to avoid the use of Alprazolam in patients who are on therapy with potent inhibitors of CYP3A. Also, caution should be taken while using drugs that moderately inhibit CYP3A and dosage adjusted.

Inducers of CYP3A: The metabolism of Alprazolam gets increased and hence its concentration decreases in presence of inducers of CYP3A such as carbamazepine.

  • CNS Depressants

The administration of benzodiazepines (including Alprazolam) results in a cumulative effect on the CNS depression when given in combination with other psychotropic medications, antihistaminics, anticonvulsants, ethanol and other drugs that themselves cause CNS depression.

  • Imipramine and Desipramine. The plasma concentration of antidepressants such as imipramine and desipramine gets increased by about 31% and 20%, respectively, when coadministered with benzodiazepines (including Alprazolam).
  • Fluoxetine: Concomitant use of fluoxetine with Alprazolam causes an increase in the plasma concentration of Alprazolam by 46%, and half-life by 17%, besides decreasing psychomotor performance.
  • Narcotics

The plasma concentration of Alprazolam gets decreased by approximately 6% and half life increased 58% when coadministered with narcotics such as Propoxyphene.

  • Oral Contraceptives

Concomitant use of Alprazolam with oral contraceptives results in an increased plasma concentration of Alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%.

  • Other drugs: Clinical studies also indicate a possible drug interaction of Alprazolam with the drugs such as
  • Isoniazid, diltiazem, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice
  • Sertraline and paroxetine
  • Ergotamine, nicardipine, amiodarone, nifedipine, and cyclosporine

Does Alprazolam have any interaction with diseases?

It has been observed that following medical conditions (disease) may interact with Alprazolam:

  • Hypersensitivity: Alprazolam is not recommended in case of people who are allergic or hypersensitive to Alprazolam or any of its ingredients or other
  • Acute Alcohol IntoxicationAdministration of benzodiazepines (e.g., Alprazolam) is contraindicated in patients with acute alcohol intoxication due to its additive effect on the central nervous system depression along with alcohol. This may lead to severe respiratory depression and death. Caution should be taken while administering benzodiazepines therapy in patients who might be prone to acute alcohol intake.
  • DepressionAlprazolam or any other benzodiazepines may cause a depression of the central nervous system. The use of the drug in patients may result in or cause worsening of mental depression as well as suicidal behavior. Besides, drug administration may cause episodes of mania (abnormally elevated mood state) and hypomania in depressed patients. It is usually recommended to use the drug with caution and avoid large quantities in patients with depression or psychiatric disorders. A close monitoring is generally advised for any changes in mood or behavior.
  • Closed-Angle GlaucomaThe use of Alprazolam (benzodiazepine) is not recommended in case of patients with acute angle-closure glaucoma or untreated open-angle glaucoma as it may lead to increased intraocular pressure.
  • SeizuresTherapy with benzodiazepines including Alprazolam may lead to seizures or its increased frequency in patients with seizure disorders. Prolonged use or excessive dosages of the drug should not be followed by abrupt cessation as it may cause seizures or result in withdrawal symptoms. Drug therapy should be terminated only gradually with tapering doses under the supervision of the doctor. Rapid withdrawal of the drug may cause status epilepticus in patients with a history of seizures.
  • Drug DependenceProlonged use or excessive dosages of benzodiazepines including Alprazolam may result in tolerance and dependence (both physical and psychological). Withdrawal symptoms may also occur following the continuous use of the drug even for 6 weeks. Patients who have a history of alcohol/ substance abuse or addiction prone individuals should be under close observation while administering therapy with benzodiazepines. Withdrawal of the drug should be done gradually and requires temporary reinstitution of benzodiazepines in case of appearance of withdrawal symptoms.
  • ObesityThe obese patients have enhanced plasma half-lives of benzodiazepines (such as Alprazolam) due to increased distribution into fat and hence require caution while being administered benzodiazepines therapy. It is generally recommended to have longer dosing intervals. Initial doses are based on actual body weight, while maintenance doses on ideal body weight in order to avoid the toxic effects.
  • Renal/Liver DiseaseBenzodiazepines such as Alprazolam undergo metabolism by the liver, and the metabolites are excreted in the urine. Administration of benzodiazepines therapy should be initiated very cautiously at lower initial dosages in patients with impaired renal and/or hepatic function as it may lead to drug accumulation and harmful effects.
  • Paradoxical ReactionsThe administration of benzodiazepines including Alprazolam in psychiatric patients and pediatric patients suffering with hyperactive aggressive disorders may result in the development of paradoxical reactions, such as aggressive behavior, excitability, nervousness, irritability, agitation, sleep disturbances, vivid dreams, nightmares and anxiety. Careful monitoring of such patients should be done for any sign of paradoxical reaction during therapy with benzodiazepines. It is generally recommended to avoid the use of benzodiazepines for the treatment of psychosis.
  • Respiratory DepressionThe use of benzodiazepines including Alprazolam may be associated with respiratory depression and apnea at high dosages or when administered intravenously. However, geriatric population, weak or severely ill patients (receiving other CNS depressants, or with limited chronic pulmonary insufficiency or other respiratory disorders) are prone even at the commonly used therapeutic doses. Caution should be taken during administration of benzodiazepines in these patients. Injectable formulations of benzodiazepines are generally not recommended in patients with severe respiratory insufficiency, sleep apnea, or hypoxia.

Where can I get more information?

Your pharmacist or health care provider can provide more information about Alprazolam.

Clinical research and current scenario of the drug

  • Bioassay studies for duration of two years indicated no evidence of carcinogenic potential of Alprazolam in rats at doses up to 30 mg/kg/day and in mice at doses up to 10 mg/kg/day.
  • Studies indicate no impairment of fertility in rats when administered with Alprazolam at doses up to 5 mg/kg/day (25 times the maximum recommended daily human dose of 10 mg/day).
  • Clinical studies are not available to support the safety and effectiveness of Alprazolam in children below 18 years of age.
  • Short term, placebo controlled studies for 10 weeks indicate the efficacy of Alprazolam in the treatment of panic disorder in patients.
  • Studies advocate the effectiveness of Alprazolam in the treatment of anxiety or anxiety with associated depressive symptomatology.
  • Controlled postmarketing discontinuation study of panic disorder patients indicate difficulty in tapering the dose of Alprazolam to zero when administered at doses greater than 4 mg/day in comparison to doses less than 4 mg/day.

 References from chemical, biological and toxicological databases

  • DrugBank: Alprazolam. http://www.drugbank.ca/drugs/DB00404
  • Alprazolam | C17H13ClN4 | ChemSpider. http://www.chemspider.com/Chemical-Structure.2034.html
  • Alprazolam: MedlinePlus Drug Information. https://www.nlm.nih.gov/medlineplus/druginfo/meds/a684001.html
  • Alprazolam | C17H13ClN4 – PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/alprazolam
  • Alprazolam – Wikipedia, the free encyclopedia. https://en.wikipedia.org/wiki/Alprazolam
  • Alprazolam for depression. http://www.ncbi.nlm.nih.gov/pubmed/22786504
  • Brief review of published alprazolam clinical studies. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1463502/
  • Alprazolam: a review of its pharmacodynamic properties and efficacy in the treatment of anxiety and depression. http://www.ncbi.nlm.nih.gov/pubmed/6141930
  • Clinical pharmacology, clinical efficacy, and behavioral toxicity of alprazolam: a review of the literature. http://www.ncbi.nlm.nih.gov/pubmed/14978513
  • The pharmacology of alprazolam: a review. http://www.ncbi.nlm.nih.gov/pubmed/2029716
  • A comparison of the safety and efficacy of alprazolam versus other agents in the treatment of anxiety, panic, and depression: a review of the literature. http://www.ncbi.nlm.nih.gov/pubmed/8262888
  • Alprazolam use and dependence. A retrospective analysis of 30 cases of withdrawal. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1002418/
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