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Comparison of somnolence associated with asenapine, olanzapine, risperidone, and haloperidol relative to placebo in patients with schizophrenia or bipolar disorder.

Gao K, Mackle M, Cazorla P, Zhao J, Szegedi A - Neuropsychiatr Dis Treat (2013)

Bottom Line: This study assessed the median time to onset, duration, and rate of somnolence associated with asenapine and other antipsychotics in both indications.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.Only asenapine and olanzapine had significantly higher rates of somnolence relative to placebo.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Mood and Anxiety Clinic in the Mood Disorders Program, Case Western Reserve University, School of Medicine, Cleveland, OH, USA;

ABSTRACT

Background: 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.

Methods: Ten clinical trials (n = 4786) were analyzed as five cohorts pooled according to indication and study design.

Results: 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.

Conclusion: 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.

No MeSH data available.


Related in: MedlinePlus

Frequency of somnolence events by intensity.Abbreviations: ASE, asenapine; HAL, haloperidol; OLA, olanzapine; PBO, placebo; RIS, risperidone.
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f1-ndt-9-1145: Frequency of somnolence events by intensity.Abbreviations: ASE, asenapine; HAL, haloperidol; OLA, olanzapine; PBO, placebo; RIS, risperidone.

Mentions: In the short-term schizophrenia cohort, the incidence of somnolence (Table 2) with all doses of asenapine was 13.1%, 6.9% with placebo, 8.5% with risperidone, 5.2% with haloperidol, and 19.1% with olanzapine. The NNH (95% CI) for asenapine and olanzapine relative to placebo was 16 (10, 43) and 8 (5, 15), respectively. The difference between risperidone or haloperidol and placebo was not significant. No patients discontinued because of somnolence/sedation in the placebo, risperidone, or haloperidol groups, but one patient (0.2%) receiving asenapine and two patients (1.0%) receiving olanzapine discontinued due to somnolence. One event of severe somnolence was reported in the asenapine group. Moderate events of somnolence with placebo, asenapine, risperidone, olanzapine, and haloperidol were experienced by five (1.3%), 13 (2.3%), two (3.4%), 13 (6.7%), and one (0.87%) patients, respectively (Figure 1). All other events of somnolence with each treatment were mild.


Comparison of somnolence associated with asenapine, olanzapine, risperidone, and haloperidol relative to placebo in patients with schizophrenia or bipolar disorder.

Gao K, Mackle M, Cazorla P, Zhao J, Szegedi A - Neuropsychiatr Dis Treat (2013)

Frequency of somnolence events by intensity.Abbreviations: ASE, asenapine; HAL, haloperidol; OLA, olanzapine; PBO, placebo; RIS, risperidone.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3755703&req=5

f1-ndt-9-1145: Frequency of somnolence events by intensity.Abbreviations: ASE, asenapine; HAL, haloperidol; OLA, olanzapine; PBO, placebo; RIS, risperidone.
Mentions: In the short-term schizophrenia cohort, the incidence of somnolence (Table 2) with all doses of asenapine was 13.1%, 6.9% with placebo, 8.5% with risperidone, 5.2% with haloperidol, and 19.1% with olanzapine. The NNH (95% CI) for asenapine and olanzapine relative to placebo was 16 (10, 43) and 8 (5, 15), respectively. The difference between risperidone or haloperidol and placebo was not significant. No patients discontinued because of somnolence/sedation in the placebo, risperidone, or haloperidol groups, but one patient (0.2%) receiving asenapine and two patients (1.0%) receiving olanzapine discontinued due to somnolence. One event of severe somnolence was reported in the asenapine group. Moderate events of somnolence with placebo, asenapine, risperidone, olanzapine, and haloperidol were experienced by five (1.3%), 13 (2.3%), two (3.4%), 13 (6.7%), and one (0.87%) patients, respectively (Figure 1). All other events of somnolence with each treatment were mild.

Bottom Line: This study assessed the median time to onset, duration, and rate of somnolence associated with asenapine and other antipsychotics in both indications.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.Only asenapine and olanzapine had significantly higher rates of somnolence relative to placebo.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Mood and Anxiety Clinic in the Mood Disorders Program, Case Western Reserve University, School of Medicine, Cleveland, OH, USA;

ABSTRACT

Background: 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.

Methods: Ten clinical trials (n = 4786) were analyzed as five cohorts pooled according to indication and study design.

Results: 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.

Conclusion: 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.

No MeSH data available.


Related in: MedlinePlus