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HALCION®, CIV (triazolam) Drug Abuse and Dependence

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Halcion contains triazolam which is a Schedule IV controlled substance.

9.2 Abuse

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Addiction-prone individuals (e.g. those with a history of drug addiction or alcoholism) should be under careful surveillance when receiving HALCION because of increased risk of abuse and dependence.

9.3 Dependence

Withdrawal symptoms, including: convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, dysphoria, perceptual disturbances, and insomnia have occurred following abrupt discontinuance of benzodiazepines, including Halcion. The more severe symptoms are usually associated with higher dosages and longer usage, although patients at recommended dosages given for as few as 1 to 2 weeks can also have withdrawal symptoms and in some patients there may be withdrawal symptoms (daytime anxiety, agitation) between nightly doses [see Warnings and Precautions (5.9)]. 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 Halcion. As with all hypnotics, repeat prescriptions should be limited to those who are under medical supervision.

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