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Triazolam Full Prescribing Information

Brand Name: Halcion
Generic Name: Triazolam

Halcion (Triazolam) is a sedative used to treat insomnia. Uses, dosage, side effects of Halcion.

Outside U.S., Brand Names also known as: Dumozolam; Novidorm; Nuctane; Somese; Somniton; Songar; Tialam; Trialam

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Halcion patient information (in plain English)

Description

Halcion Tablets contain triazolam, a triazolobenzodiazepine hypnotic agent used to treat sleep disorders.

Pharmacology

Peak plasma levels are reached within 2 hours following oral administration.

In sleep laboratory studies, triazolam tablets significantly decreased sleep latency, increased the duration of sleep, and decreased the number of nocturnal awakenings. After 2 weeks of consecutive nightly administration, the drug's effect on total wake time is decreased, and the values recorded in the last third of the night approach baseline levels. On the first and/or second night after drug discontinuance (first or second post-drug night), total time asleep, percentage of time spent sleeping, and rapidity of falling asleep frequently were significantly less than on baseline (predrug) nights. This effect is often called "rebound" insomnia.

Two clinical findings were reported to occur after several weeks of nightly use of rapidly eliminated benzodiazepine hypnotics: 1) increased wakefulness during the last third of the night and 2) the appearance of increased daytime anxiety after 10 days of continuous treatment.

 

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Indications and Usage

Anxiety

Triazolam is indicated for the short-term treatment of insomnia (generally 7-10 days). Use for more than 2-3 weeks requires complete reevaluation of the patient.


 

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The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning.

Prescriptions for triazolam should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply.

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Contraindications

Triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines.

Triazolam is contraindicated in pregnant women. If there is a likelihood of the patient becoming pregnant while receiving triazolam, she should be warned of the potential risk to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.

Triazolam is contraindicated in patients who have myasthenia gravis or a history of uncorrected narrow-angle glaucoma.

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Warnings

Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.

The failure of insomnia to remit after 7-10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness.

Worsening of insomnia or the emergence of new abnormalities of thinking or behavior may be the consequence of an unrecognized psychiatric or physical disorder. These have also been reported to occur in association with the use of triazolam.

Because some of the adverse effects of triazolam appear to be dose related, it is important to use the smallest possible effective dose. Elderly patients are especially susceptible to dose related adverse effects.

An increase in daytime anxiety has been reported for triazolam after as few as 10 days of continuous use. In some patients this may be a manifestation of interdose withdrawal. If increased daytime anxiety is observed during treatment, discontinuation of treatment may be advisable.

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of benzodiazepine hypnotics including triazolam. Some of these changes may be characterized by decreased inhibition, e.g. aggressiveness and extroversion that seem excessive, similar to that seen with alcohol and other CNS depressants (e.g., sedative/hypnotics). Other kinds of behavioral changes have also been reported, for example, bizarre behavior, agitation, hallucinations, depersonalization. In primarily depressed patients, the worsening of depression, including suicidal thinking, has been reported in association with the use of benzodiazepines.

As with some, but not all benzodiazepines, anterograde amnesia of varying severity and paradoxical reactions have been reported following therapeutic doses of triazolam. Data from several sources suggest that anterograde amnesia may occur at a higher rate with triazolam than with other benzodiazepine hypnotics.

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Precautions

In elderly and/or debilitated patients it is recommended that treatment with triazolam tablets be initiated at 0.125 mg to decrease the possibility of development of oversedation, dizziness, or impaired coordination.

Some side effects reported in association with the use of triazolam appear to be dose related. These include drowsiness, dizziness, light-headedness, and amnesia.

The relationship between dose and what may be more serious behavioral phenomena is less certain. Specifically, some evidence, based on spontaneous marketing reports, suggests that confusion, bizarre or abnormal behavior, agitation, and hallucinations may also be dose related, but this evidence is inconclusive. In accordance with good medical practice it is recommended that therapy be initiated at the lowest effective dose.

Suicide: Caution should be exercised if triazolam is prescribed to patients with signs or symptoms of depression that could be intensified by hypnotic drugs. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in these patients, and the least amount of drug that is feasible should be available to the patient at any one time.

The usual precautions should be observed in patients with impaired renal or hepatic function, chronic pulmonary insufficiency, and sleep apnea. In patients with compromised respiratory function, respiratory depression and apnea have been reported infrequently.

Usage in Children:: The safety and effectiveness of olanzapine in children below the age of 18 have not been established.

Pregnancy and Withdrawl: Benzodiazepines may cause fetal damage when administered during pregnancy. Do not take if pregnant or attempting to become pregnant. Administration of triazolam to nursing mothers is not recommended.

It is to be considered that the child born of a mother who is on benzodiazepines may be at some risk for withdrawal symptoms from the drug, during the postnatal period. Also, neonatal flaccidity has been reported in an infant born of a mother who had been receiving benzodiazepines.

Interference with Cognitive or Motor Performance: Because of its depressant CNS effects, patients receiving triazolam should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle.

For the same reason, patients should be cautioned about the concomitant ingestion of alcohol and other CNS depressant drugs during treatment with triazolam tablets.

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Drug Interactions

Triazolam produces additive CNS depressant effects when co-administered with alcohol, antihistamines, anticonvulsants, or psychotropic medications which themselves can produce CNS depression.

Consideration of dose reduction may be appropriate when patients are treated concomitantly with triazolam and either cimetidine or erythromycin.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes clozapine, ketoconazole, nefazodone, valproic acid, and medicines used to treat HIV infection. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

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Adverse Reactions

The most troublesome side effects were extensions of the pharmacologic activity of triazolam, e.g. excessive daytime drowsiness, unusual weakness, dizziness, lightheadedness, headache, clumsiness, or unsteadiness.

The most serious adverse reactions which may occur include memory impairment, abnormal thinking/behavior, confusion, anxiety, and depression.

Drug Abuse and Dependence: Triazolam is a controlled substance under the Controlled Substance Act, and triazolam tablets have been assigned to Schedule IV.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, dysphoria, perceptual disturbances and insomnia), have occurred following abrupt discontinuance of benzodiazepines, including triazolam. The more severe symptoms are usually associated with higher dosages and longer usage, although patients at therapeutic dosages given for as few as 1-2 weeks can also have withdrawal symptoms and in some patients there may be withdrawal symptoms (daytime anxiety, agitation) between nightly doses. Consequently, abrupt discontinuation should be avoided and a gradual dosage tapering schedule is recommended in any patient taking more than the lowest dose for more than a few weeks. The recommendation for tapering is particularly important in any patient with a history of seizure.

The risk of dependence is increased in patients with a history of alcoholism, drug abuse, or in patients with marked personality disorders. Such dependence-prone individuals should be under careful surveillance when receiving triazolam. As with all hypnotics, repeat prescriptions should be limited to those who are under medical supervision.

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Overdose

Signs and Symptoms

Symptoms of Triazolam, Halcion overdose may include confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness. Respiratory depression and apnea have been reported with overdosages of triazolam. Seizures have occasionally been reported after overdosages.

Death has been reported in association with overdoses of triazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including triazolam, and alcohol; benzodiazepine and alcohol levels seen in some of these cases have been lower than those usually associated with reports of fatality with either substance alone.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

As in all cases of drug overdosage, respiration, pulse, and blood pressure should be monitored and supported by general measures when necessary. Immediate gastric lavage should be performed. An adequate airway should be maintained. Intravenous fluids may be administered.

Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected.

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Dosage

Do not exceed the recommended dosage or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit forming.

  • Follow the directions for using this medicine provided by your doctor.
  • Store this medicine at room temperature, away from heat and light.
  • Avoid drinking grapefruit juice 1 hour before or 2 hours after taking this medicine.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

It is important to individualize the dosage of triazolam tablets for maximum beneficial effect and to help avoid significant adverse effects.

Adults: The recommended dose for most adults is 0.25 mg before retiring. A dose of 0.125 mg may be found to be sufficient for some patients (e.g., low body weight). A dose of 0.5 mg should be used only for exceptional patients who do not respond adequately to a trial of a lower dose since the risk of several adverse reactions increases with the size of the dose administered. A dose of 0.5 mg should not be exceeded.

Elderly and Debilitated Patients or those with Hypotension: The recommended dosage range is 0.125 mg to 0.25 mg. Therapy should be initiated at 0.125 mg in this group and the 0.25 mg dose should be used only for exceptional patients who do not respond to a trial of the lower dose. A dose of 0.25 mg should not be exceeded in these patients.

As with all medications, the lowest effective dose should be used.

Usage in Children:: Olanzapine is not indicated for patients under 18 years of age.

Discontinuation: You may experience trouble sleeping for 1 to 2 nights after you stop taking this medicine. If it continues, contact your doctor.

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How Supplied

Scored tablets are available in 0.125 mg and 0.25 mg of Triazolam.

Halcion Patient Information Sheet (in plain English)

Extensive information on Anxiety Disorders, symptoms, causes, treatment


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

Copyright © 2007 Healthyplace Inc. All rights reserved.

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back to: Psychiatric Medications Pharmacology Homepage

Last Updated: 09 April 2017
Reviewed by Harry Croft, MD

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