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

Neuropsychiatric Disease and Treatment

Volumn 9, Issue , 2013, Pages 1145-1157

  Gao, Keming ^a   Mackle, Mary ^b   Cazorla, Pilar ^b   Zhao, Jun ^b   Szegedi, Armin ^b  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Asenapine; Bipolar disorder; Schizophrenia; Sedation; Somnolence

Indexed keywords

ANTIDEPRESSANT AGENT; ANXIOLYTIC AGENT; ASENAPINE; BENZODIAZEPINE DERIVATIVE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CHOLINERGIC RECEPTOR BLOCKING AGENT; DOPAMINE RECEPTOR BLOCKING AGENT; HALOPERIDOL; HYPNOTIC AGENT; LORAZEPAM; MONOAMINE OXIDASE INHIBITOR; MOOD STABILIZER; NEUROLEPTIC AGENT; OLANZAPINE; PLACEBO; RISPERIDONE; TRICYCLIC ANTIDEPRESSANT AGENT;

ARTICLE; BIPOLAR DISORDER; BIPOLAR MANIA; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; COMPARATIVE STUDY; DISEASE DURATION; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; HUMAN; LOW DRUG DOSE; MANIA; MONOTHERAPY; MORBIDITY; MULTICENTER STUDY (TOPIC); NEGATIVE SYNDROME; POSITIVE AND NEGATIVE SYNDROME SCALE; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SOMNOLENCE; STUDY DESIGN; TREATMENT DURATION;

EID: 84882773475     PISSN: 11766328     EISSN: 11782021     Source Type: Journal    
DOI: 10.2147/NDT.S41333     Document Type: Article

References (23)

1. Meyer RE, Salzman C, Youngstrom EA, et al. Suicidality and risk of suicide - definition, drug safety concerns, and a necessary target for drug development: a consensus statement. J Clin Psychiatry. 2010;71(8): e1-e21.
2. Gao K, Ganocy SJ, Gajwani P, Muzina DJ, Kemp DE, Calabrese JR. A review of sensitivity and tolerability of antipsychotics in patients with bipolar disorder or schizophrenia: focus on somnolence. J Clin Psychiatry. 2008;69(2):302-309.
3. Shahid M, Walker GB, Zorn SH, Wong EH. Asenapine: a novel psychopharmacologic agent with a unique human receptor signature. J Psychopharmacol. 2009;23(1):65-73.
4. Gerrits MG, de Greef R, Dogterom P, Peeters PA. Valproate reduces the glucuronidation of asenapine without affecting asenapine plasma concentrations. J Clin Pharmacol. 2012;52(5):757-765.
5. Kane JM, Cohen M, Zhao J, Alphs L, Panagides J. Efficacy and safety of asenapine in a placebo-and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. J Clin Psychopharmacol. 2010;30(2):106-115.
6. Kane JM, Mackle M, Snow-Adami L, Zhao J, Szegedi A, Panagides J. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry. 2011;72(3):349-355.
7. Potkin SG, Cohen M, Panagides J. Efficacy and tolerability of asenapine in acute schizophrenia: a placebo-and risperidone-controlled trial. J Clin Psychiatry. 2007;68(10):1492-1500.
8. Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R. Long-term assessment of asenapine versus olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry. 2010;43(4): 138-146.
9. McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord. 2009;11(7):673-686.
10. McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009;11(8):815-826.
11. McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010;126(3):358-365.
12. McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2010; 122(1-2):27-38.
13. Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012;32(1):46-55.
14. Citrome L. Asenapine for schizophrenia and bipolar disorder: a review of the efficacy and safety profile for this newly approved sublingually absorbed second-generation antipsychotic. Int J Clin Pract. 2009; 63(12):1762-1784.
15. Buchanan RW, Panagides J, Zhao J, et al. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012;32(1):36-45.
16. Szegedi A, Verweij P, van Duijnhoven W, Mackle M, Cazorla P, Fennema H. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry. 2012;73(12):1533-1540.
17. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4(2):213-226.
18. Said Q, Gutterman EM, Kim MS, Firth SD, Whitehead R, Brixner D. Somnolence effects of antipsychotic medications and the risk of unintentional injury. Pharmacoepidemiol Drug Saf. 2008;17(4): 354-364.
19. Bymaster FP, Calligaro DO, Falcone JF, et al. Radioreceptor binding profile of the atypical antipsychotic olanzapine. Neuropsychopharmacology. 1996;14(2):87-96.
20. Nicholson AN, Pascoe PA, Turner C, et al. Sedation and histamine H1-receptor antagonism: studies in man with the enantiomers of chlorpheniramine and dimethindene. Br J Pharmacol. 1991;104(1): 270-276.
21. Harvey AG, Schmidt DA, Scarna A, Semler CN, Goodwin GM. Sleep-related functioning in euthymic patients with bipolar disorder, patients with insomnia, and subjects without sleep problems. Am J Psychiatry. 2005;162(1):50-57.
22. Palmese LB, DeGeorge PC, Ratliff JC, et al. Insomnia is frequent in schizophrenia and associated with night eating and obesity. Schizophr Res. 2011;133(1-3):238-243.
23. Gao K, Kemp DE, Fein E, et al. Number needed to treat to harm for discontinuation due to adverse events in the treatment of bipolar depression, major depressive disorder, and generalized anxiety disorder with atypical antipsychotics. J Clin Psychiatry. 2011;72(8):1063-1071.