Triazolam (Triazolam) - Indications and Dosage

INDICATIONS AND USAGE

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

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

DOSAGE AND ADMINISTRATION

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

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.

In geriatric and/or debilitated patients 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.

HOW SUPPLIED

Triazolam Tablets USP for oral administration are available as:

0.125 mg white, unscored, oval-shaped tablets (Identified 54 519).

NDC 0054-8858-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-4858-06: Bottles of 10 tablets.

NDC 0054-4858-29: Bottles of 500 tablets.

0.25 mg blue, scored, oval-shaped tablets (Identified 54 620).

NDC 0054-8859-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-4859-06: Bottles of 10 tablets.

NDC 0054-4859-29: Bottles of 500 tablets.

Store at controlled room temperature

15°-30°C (59°-86°F).

The text of the patient insert for triazolam is set forth below:

INFORMATION FOR THE PATIENT ABOUT TRIAZOLAM TABLETS, USP

INTRODUCTION

Triazolam tablets are intended to help you sleep. It is one of several benzodiazepine sleeping pills that have generally similar properties. Anyone who is considering using one of these medications should be aware of both their benefits and several important risks and limitations, including diminishing effectiveness with continued use and the possible development of dependence (addiction) and possibly mental changes particularly when the drugs are used for more than a few days to a week. This patient information statement is intended to provide you with knowledge about this class of medications in general and about triazolam in particular that will be useful to guide you in the safe use of this product. BUT IT SHOULD NOT REPLACE A DISCUSSION BETWEEN YOU AND YOUR PHYSICIAN ABOUT THE RISKS AND BENEFITS OF TRIAZOLAM.

This leaflet will focus on the beneficial and adverse effects of all members of this class of medications, as well as some specific information about triazolam. There are some differences among these products, and your physician may wish to discuss any specific advantages and disadvantages of particular members of this drug class with you.