![]() In all cases in that controlled trial, the confusion resolved soon after termination of treatment. In a controlled trial in adults where patients were randomized to fixed total daily doses of 3 g, 6 g, or 9 g per night or placebo, a dose-response relationship for confusion was demonstrated, with 17% of patients at 9 g per night experiencing confusion. Other Behavioral or Psychiatric Adverse Reactionsĭuring adult clinical trials in narcolepsy, 3% of 781 patients treated with XYREM experienced confusion, with incidence generally increasing with dose. Patients with a previous history of a depressive illness and/or suicide attempt should be monitored carefully for the emergence of depressive symptoms while taking XYREM. The emergence of depression in patients treated with XYREM requires careful and immediate evaluation. In the pediatric clinical trial in patients with narcolepsy (n=104), one patient experienced suicidal ideation and two patients reported depression while taking XYREM. In most cases, no change in XYREM treatment was required. Adverse reactions of depression were reported by 7% of 781 XYREM-treated patients, with four patients (<1%) discontinuing because of depression. XYREM was not involved in the second suicide. Of the two suicides, one patient used XYREM in conjunction with other drugs. In adult clinical trials in patients with narcolepsy (n=781), there were two suicides and two attempted suicides in XYREM-treated patients, including three patients with a previous history of depressive psychiatric disorder. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy and among patients with narcolepsy. ![]() Prescribers should be aware that increased central apneas and clinically relevant desaturation events have been observed with XYREM administration in adult and pediatric patients. In overdoses, life-threatening respiratory depression has been reported. ![]() XYREM may impair respiratory drive, especially in patients with compromised respiratory function. Respiratory Depression and Sleep-Disordered Breathing
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