Herbal Spotlight
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NEW WARNING
Sanofi-Aventis has issued a “Dear Healthcare Professional” letter to bring attention to new safety recommendations regarding their sedative-hypnotic drug zolpidem tartrate (Ambien, Ambien CR). The company has revised the “Warnings” section of the prescribing information to include the following statement: “The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric, medical illness, or both that should be evaluated.” The warnings also now indicate the possibility of rare, but severe anaphylactic and anaphylactoid reactions when patients take sedative-hypnotics. Case reports of angioedema of the tongue, glottis, or larynx have been reported after the first dose of Ambien, and patients are warned that airway obstruction resulting in death could occur. If a patient experiences angioedema, the patient should not be treated with Ambien again. The “Information for Patients” section now includes the possibility of complex behaviors occurring in patients who are not fully awake. These behaviors include preparing and eating food, making phone calls, having sex, and sleep-driving, often with the patient having no memory of the events. Patients should be urged to avoid combining Ambien with other CNS depressants or alcohol and to report any of these complex behaviors immediately.
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zolpidem tartrate