MEDICATION GUIDE

Read this Medication Guide before you start taking triazolam and each time you get a refill.

There may be new information. This Medication Guide does not take the place of talking

to your doctor about your medical condition or treatment. You and your doctor should talk

about the SEDATIVE-HYPNOTIC when you start taking it and at regular checkups.

What is the most important information I should know about triazolam?

After taking a SEDATIVE-HYPNOTIC, you may get up out of bed while not beingfully awake and do an activity that you do not know you are doing. The next morning,you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with a SEDATIVE-HYPNOTIC. Reported activities include:

• driving a car (“sleep-driving”)

• making and eating food

• talking on the phone

• having sex

• sleep-walking

Important:

1.Take triazolam exactly as prescribed

• Do not take more triazolam than prescribed.

• Take triazolam right before you get in bed, not sooner.

2.Do not take triazolam if you:

• drink alcohol

• take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take triazolam with your other medicines

• cannot get a full night’s sleep

• are pregnant or considering becoming pregnant

3.Call your doctor right away if you find out that you have done any of the aboveactivities after taking triazolam.

What are SEDATIVE-HYPNOTICS?

SEDATIVE-HYPNOTICs are sleep medicines. SEDATIVE-HYPNOTICs are used in adults for the treatment of the symptom of trouble falling asleep due to insomnia.

Triazolam is not indicated for use in children.

Elderly patients are especially susceptible to dose related adverse effects when taking triazolam.

Triazolam is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep triazolam in a safe place to prevent misuse and abuse. Selling or giving away triazolam may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take triazolam?

Do not take triazolam if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in triazolam.

SEDATIVE-HYPNOTICS may not be right for you. Before starting SEDATIVE-HYPNOTICS,tell your doctor about all of your health conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts

• have a history of drug or alcohol abuse or addiction

• have kidney or liver disease

• have a lung disease or breathing problems

• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact, sometimes causing side effects. Do not take SEDATIVE-HYPNOTICS with othermedicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Triazolam should not be taken with potent inhibitors of CYP 3A including ketoconazole, itraconazole, nefazodone and possibly other azole-type antifungal agents.

How should I take triazolam?

• Take triazolam exactly as prescribed. Do not take more triazolam than prescribed for you.

• Take triazolam right before you get into bed. Or you can take triazolam after you have been in bed and have trouble falling asleep.

• Do not take triazolam with or right after a meal.

• Do not take triazolam unless you are able to get a full night’s sleep before youmust be active again.

• Call your healthcare provider if your insomnia worsens or is not better within7 to 10 days. This may mean that there is another condition causing your sleep problem.

• If you take too much triazolam or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of SEDATIVE-HYPNOTICS?

Serious side effects of SEDATIVE-HYPNOTICS include:

• getting out of bed while not being fully awake and do an activity that you donot know you are doing. (See “What is the most important information I should know about SEDATIVE-HYPNOTICS?)

• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.

• memory loss, including “traveler’s amnesia”

• anxiety

• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking SEDATIVE-HYPNOTICS.

Call your doctor right away if you have any of the above side effects or anyother side effects that worry you while using the SEDATIVE-HYPNOTIC.

Common side effects of triazolam include:

• drowsiness

• headache

• dizziness

• lightheadedness

• “pins and needles” feelings on your skin

• difficulty with coordination

• You may still feel drowsy the next day after taking triazolam. Do not drive or doother dangerous activities (including operating machinery) after taking triazolamuntil you feel fully awake.

• You may have withdrawal symptoms for 1 to 2 days when you stop taking the SEDATIVE-HYPNOTIC suddenly. Withdrawal symptoms include trouble sleeping, unpleasant feelings, stomach and muscle cramps, vomiting, sweating, shakiness, and seizures.

These are not all the side effects of SEDATIVE-HYPNOTICS. Ask your doctor or pharmacist for more information.

How should I store triazolam?

• Store triazolam at room temperature between 59° and 86° F (15° to 30°C).

• Protect from light.

• Keep triazolam and all medicines out of the reach of children.

• Do not use triazolam after the expiration date on the bottle.

General Information about SEDATIVE-HYPNOTICS

• Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide.

• Do not use the SEDATIVE-HYPNOTIC for a condition for which it was not prescribed.

• Do not give the SEDATIVE-HYPNOTIC to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about triazolam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about triazolam that was written for healthcare professionals.

If you would like more information, contact 1-800-962-8364.

What are the ingredients in triazolam?

Active Ingredient: Triazolam

Inactive Ingredients: 0.125 mg-corn starch, docusate sodium, lactose (anhydrous),magnesium stearate, microcrystalline cellulose; 0.25 mg-corn starch,docusate sodium, FD&C Blue No. 1, lactose (anhydrous), magnesium stearate,microcrystalline cellulose.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

4076601//05 Revised February 2010

© RLI, 2010

Package Label - Triazolam Tablets, USP