Department of Psychiatry, Mood and Anxiety Clinic in the Mood Disorders Program, Case Western Reserve University, School of Medicine, Cleveland, OH, USA;
Neuropsychiatr Dis Treat. 2013;9:1145-57. doi: 10.2147/NDT.S41333. Epub 2013 Aug 22.
Patients with schizophrenia or bipolar disorder (BPD) may be differentially sensitive to antipsychotics. This study assessed the median time to onset, duration, and rate of somnolence associated with asenapine and other antipsychotics in both indications.
Ten clinical trials (n = 4786) were analyzed as five cohorts pooled according to indication and study design.
In the short-term schizophrenia cohort, the incidence of somnolence was 13.1%, 19.1%, 8.5% 5.2%, and 6.9% with asenapine, olanzapine, risperidone, haloperidol, and placebo, respectively. Median time to onset of somnolence was 2 days for asenapine and olanzapine, and 6, 3, and 7 days for risperidone, haloperidol, and placebo, respectively. Median duration was 15 days for asenapine and olanzapine, and 3, 22.5, and 4.5 days for risperidone, haloperidol, and placebo, respectively. In the long-term schizophrenia cohort, the incidence, time to onset, and duration of somnolence with asenapine and olanzapine were 18.4% versus 19.6%, 9.0 days versus 12 days, and 22 days versus 21 days, respectively. In schizophrenia with persistent negative symptoms, the incidence, median time to onset, and duration of somnolence with asenapine and olanzapine were 18.5% versus 21.1%, 9.0 days versus 7.5 days, and 25.0 days versus 41.5 days, respectively. In the monotherapy for BPD cohort, the incidence of somnolence with asenapine, olanzapine, and placebo was 23.8%, 26.4%, and 6.4%, respectively. Median time to onset and duration of somnolence with asenapine, olanzapine, and placebo were 1, 2, and 2 days, respectively, and 7, 8.5, and 5 days. In the adjunctive therapy for BPD cohort, the incidence, median time to onset, and duration of somnolence with asenapine and placebo were 24.0% versus 10.2%, 1.5 days versus 2 days, and 12.5 days versus 7 days, respectively.
In the short-term schizophrenia cohort, time to onset and duration of somnolence with asenapine was similar to that with olanzapine and haloperidol. Only asenapine and olanzapine had significantly higher rates of somnolence relative to placebo. The time to onset, duration, and incidence of somnolence with asenapine and olanzapine was similar in patients with long-term schizophrenia and those with BPD. Patients with BPD were more sensitive than those with schizophrenia to asenapine and olanzapine.
精神分裂症或双相情感障碍（BPD）患者可能对抗精神病药的敏感性不同。本研究评估了阿塞那平与其他抗精神病药在这两种适应症中的起始时间、持续时间和昏睡发生率。
根据适应症和研究设计，对 10 项临床试验（n=4786）进行了分析，共分为 5 个队列。
在短期精神分裂症队列中，昏睡的发生率分别为阿塞那平 13.1%、19.1%、8.5%、5.2%和 6.9%，而奥氮平、利培酮、氟哌啶醇和安慰剂的发生率分别为 13.1%、19.1%、8.5%、5.2%和 6.9%。昏睡的起始时间分别为阿塞那平和奥氮平 2 天，利培酮、氟哌啶醇和安慰剂 6、3、7 天。昏睡的持续时间分别为阿塞那平和奥氮平 15 天，利培酮、氟哌啶醇和安慰剂 3、22.5、4.5 天。在长期精神分裂症队列中，阿塞那平和奥氮平的昏睡发生率、起始时间和持续时间分别为 18.4%与 19.6%、9.0 天与 12 天、22 天与 21 天。在伴有持续性阴性症状的精神分裂症中，阿塞那平和奥氮平的昏睡发生率、起始时间和持续时间分别为 18.5%与 19.1%、9.0 天与 7.5 天、25.0 天与 41.5 天。在 BPD 的单药治疗队列中，阿塞那平、奥氮平和安慰剂的昏睡发生率分别为 23.8%、26.4%和 6.4%。阿塞那平、奥氮平和安慰剂的昏睡起始时间和持续时间分别为 1、2 和 2 天、7、8.5 和 5 天。在 BPD 的辅助治疗队列中，阿塞那平和安慰剂的昏睡发生率、起始时间和持续时间分别为 24.0%与 10.2%、1.5 天与 2 天、12.5 天与 7 天。
在短期精神分裂症队列中，阿塞那平和奥氮平的昏睡起始时间和持续时间与氟哌啶醇相似。只有阿塞那平和奥氮平的昏睡发生率明显高于安慰剂。在长期精神分裂症患者和 BPD 患者中，阿塞那平和奥氮平的昏睡起始时间、持续时间和发生率相似。与精神分裂症患者相比，BPD 患者对阿塞那平和奥氮平更为敏感。
