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Patient Package Insert
The text of the patient insert for triazolam is set forth below.
Introduction: Triazolam is 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.
Effectiveness Of Benzodiazepine Sleeping Pills: Benzodiazepine sleeping pills are effective medications and are relatively free of serious problems when they are used for short-termmanagement of sleep problems (insomnia). insomnia is not always the same. It may be reflected in difficulty in falling asleep, frequent awakening during the night, and/or early morning awakening. Insomnia is often transient in nature, responding to brief treatment with sleeping pills. Use for more than a short while requires discussion with your physician about the risks and benefits of prolonged use.
Side Effects
Common Side Effects: The most common side effects of benzodiazepine sleeping pills are related to the ability of the medications to make you sleepy; drowsiness, dizziness, lightheadedness, and difficulty with coordination. Users must be cautious about engaging in hazardous activities requiring complete mental alertness, e.g. operating machinery or driving a motor vehicle. Do not take alcohol while using triazolam. Benzodiazepine sleeping pills should not be used with other medications or substances that may cause drowsiness, without discussing said use with your physician.
How sleepy you are the day after you use one of these sleep medications depends on your individual response and on how quickly the product is eliminated from your body. The larger the dose, the more likely an individual will experience next day residual effects such as drowsiness. For this reason, it is important to use the lowest effective dose for each individual patient. Benzodiazepines that are eliminated rapidly, (e.g., triazolam) tend to cause less next day drowsiness but may cause more withdrawal problems the day after use.
Special Concerns
Memory Problems: All benzodiazepine sleeping pills can cause a special type of amnesia (memory loss) in which a person may not recall events occurring during some period of time, usually several hours, after taking a drug. This is ordinarily not a problem, because the person taking a sleeping pill intends to be asleep during this vulnerable period of time. It can be a problem when the drugs are taken to induce sleep while traveling, such as during an airplane flight, because the person may awake before the effect of the drug is gone. This has been called "traveler's amnesia". Triazolam is more likely than other members of the class to cause this problem.
Tolerance/Withdrawal Phenomena: Some loss of effectiveness or adaptation to the sleep inducing effects of these medications may develop after nightly use for more than a few weeks and there may be a degree of dependence that develops. For the benzodiazepine sleeping pills that are eliminated quickly from the body, a relative deficiency of the drug may occur at some point in the interval between each night's use. This can lead to (1) increased wakefulness during the last third of the night, and (2) the appearance of increased signs of daytime anxiety or nervousness. These two events have been reported in particular for triazolam.
There can be more severe `withdrawal' effects when a benzodiazepine sleeping pill is stopped. Such effects can occur after discontinuing these drugs following use for only a week or two, but may be more common and more severe after longer periods of continuous use. One type of withdrawal phenomenon is the occurrence of what is known as `rebound insomnia'. That is, on the first few nights after the drug is stopped, insomnia is actually worse than before the sleeping pill was given. Other withdrawal phenomena following abrupt stopping of benzodiazepine sleeping pills range from mild unpleasant feelings to a major withdrawal syndrome which may include abdominal and muscle cramps, vomiting, sweating, tremor, and rarely, convulsions. These more severe withdrawal phenomena are uncommon.
Dependence/Abuse Phenomena: All benzodiazepine sleeping pills can cause dependence (addiction), especially when used regularly for more than a few weeks or at higher doses. Some people develop a need to continue taking these drugs, either at the prescribed dose or at increasing doses, not so much for continued therapeutic effect, but rather, to avoid withdrawal phenomena and/or to achieve nontherapeutic effects. Individuals who have been dependent on alcohol or other drugs may be at particular risk of becoming dependent on drugs in this class, but all people appear to be at some risk. This possibility must be considered before extending the use of these drugs for more than a few weeks.
Mental and Behavioral Changes: A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of benzodiazepine sleeping pills. Some of these changes are like the release of inhibition seen in association with alcohol, e.g. aggressiveness and extroversion that seem out of character. Others, however, can be more unusual and more extreme, such as confusion, bizarre behavior, agitation, hallucinations, depersonalization, and worsening of depression, including suicidal thinking. It is rarely clear whether such events are induced by the drug being taken, are caused by some underlying illness or are simply spontaneous happenings. In fact, worsened insomnia may in some cases be associated with illnesses that were present before the medication was used. In any event, the most important fact is to understand that regardless of the cause, users of these medications should promptly report any mental or behavioral changes to their doctor.
Effects on Pregnancy: Certain benzodiazepines have been linked to birth defects when administered during the early months of pregnancy. In addition, the administration of benzodiazepines during the last weeks of pregnancy has been associated with sedation of the fetus. Consequently, the use of this drug should be avoided at any time during pregnancy.
Interactions with Other Medications
HALCION should not be taken with ketoconazole, itraconazole and nefazodone. Taking HALCION with certain other
medications may cause increased levels of the drug in the blood and result in an excessive effect. Always tell your
doctor about all medications you are taking.
Safe Use Of Benzodiazepine Sleeping Pills: To assure the safe and effective use of triazolam, you should adhere to the following cautions:
- Triazolam is a prescription medication and therefore, should be used only as directed by your doctor. Follow your doctor's advice about how to take it, when to take it, and how long to take it. As with other prescription medication, triazolam should be taken only by the individual for whom it is prescribed.
- Do not extend your use of triazolam beyond 7-10 days without first consulting your physician.
- If you develop any unusual and disturbing thoughts or behavior during treatment with triazolam, you should discuss such problems with your physician.
- Inform your physician about any alcohol consumption and medicine you are taking now, including drugs you may buy without a prescription. Do not use alcohol while taking triazolam.
- Do not take triazolam in circumstances where a full night's sleep and elimination of the drug from the body are not possible before you would again need to be active and functional, e.g. an overnight flight of less than 7-8 hours, because amnestic episodes have been reported in such situations.
- Do not increase the prescribed dose except on the advice of your physician.
- Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.
- Be aware that you may experience an increase in sleep difficulties (rebound insomnia) on the first night or two after discontinuing triazolam.
- Inform your physician if you are planning to become pregnant, if you are pregnant, or if you become pregnant while you are taking this medicine. The use of triazolam should be avoided at any time during pregnancy.
- Always tell your doctor about all medications you are taking.
Pharmacia & Upjohn Company
A subsidiary of Pharmacia Corporation
Kalamazoo, Michigan 49001, USA
Revised January 2003 812 110 831
692167
