Surveys or studies that demonstrate frequency of adverse reaction have not been conducted.
Clinically Significant Adverse Reactions (Frequency Unknown): Dependence and Withdrawal Symptoms: Drug dependence may occur with use, so this drug should be administered with caution while carefully monitoring patients. Furthermore, a rapid reduction in dose or discontinuation during use may lead to withdrawal symptoms such as rebound insomnia or irritability. If administration is to be discontinued, it should be done carefully by gradually decreasing the dose.
Psychiatric Symptoms and Disturbances of Consciousness: Psychiatric symptoms and disturbances of consciousness (e.g., delirium, confusion, somnambulism, hallucinations, excitation, disinhibition, depressed level of consciousness) may occur. Patients, hence, should be carefully monitored. If any abnormal findings are observed, administration of this drug should be discontinued and appropriate therapeutic measures should be taken.
Transient Anterograde Amnesia and Twilight States: Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, making phone calls or having sex, with amnesia for the event, have been reported in patients who had taken zolpidem and were not fully awake. The use of alcohol and other CNS-depressants with zolpidem appears to increase the risk of such behaviours, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of zolpidem should be strongly considered for patients who report such behaviours (for example, sleep driving), due to the risk to the patient and others.
Respiratory Depression: Respiratory depression may occur. Furthermore, carbon dioxide narcosis may occur if this drug are administered to a patient with highly compromised respiratory function. Therefore, in such circumstances, appropriate therapeutic measures such as airway management and ventilation should be taken.
Hepatic Function Disorder, Jaundice: Hepatic function disorder and jaundice accompanied by increased AST (GOT), increased ALT (GPT), increased γ-GTP, and increased Al-P may occur. Patients, hence, should be carefully monitored. If any abnormal findings are observed, administration of this drug should be discontinued and appropriate therapeutic measures should be taken.
Other Adverse Reactions: See Table 2.
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