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Asenapine
medication Under reviewAn atypical antipsychotic medication used to treat schizophrenia and acute manic or mixed episodes associated with bipolar I disorder.
Research summary
Human research on asenapine is extensive, but it is almost entirely focused on patients with schizophrenia or bipolar I disorder rather than healthy volunteers. Phase I pharmacokinetic work in healthy subjects has primarily examined how the drug is absorbed, metabolized, and eliminated, confirming the utility of sublingual administration and characterizing dose-related exposure and safety in short-term settings. Beyond these early studies, virtually all efficacy and long-term safety data come from randomized controlled trials and extension studies in clinical populations. Across multiple trials, asenapine has demonstrated efficacy in reducing acute manic and mixed symptoms in bipolar I disorder and in improving psychotic symptoms in schizophrenia, as well as helping to prevent relapse when used as maintenance therapy. Safety data show a predictable side-effect profile with sedation, dizziness, insomnia, weight gain, and metabolic changes among the most frequently reported adverse events. Because these effects are clinically significant and there is no evidence of benefit in healthy individuals, asenapine should be regarded strictly as a prescription antipsychotic medication rather than a health supplement.
Reported Benefits
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Quantification of asenapine and three metabolites in human plasma using liquid chromatography-tandem mass spectrometry with automated solid-phase extraction: application to a phase I clinical trial with asenapine in healthy male subjects.
Kaufmann B, Spengler J, Maier G, et al.
Asenapine pharmacokinetics and safety after single and multiple sublingual doses in healthy volunteers
McIntyre RS, Cohen A, et al.
Reported Side Effects
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Asenapine pharmacokinetics and safety after single and multiple sublingual doses in healthy volunteers
McIntyre RS, Cohen A, et al.
SAPHRIS (asenapine) prescribing information: clinical pharmacology and pharmacokinetics in healthy subjects
Organon LLC
No reports yet
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Add Asenapine to your stack to report effects
Asenapine pharmacokinetics and safety after single and multiple sublingual doses in healthy volunteers
McIntyre RS, Cohen A, et al.
SAPHRIS (asenapine) prescribing information: clinical pharmacology and pharmacokinetics in healthy subjects
Organon LLC
No reports yet
Be the first to report this effect and help the community.
Add Asenapine to your stack to report effects
Asenapine pharmacokinetics and safety after single and multiple sublingual doses in healthy volunteers
McIntyre RS, Cohen A, et al.
SAPHRIS (asenapine) prescribing information: clinical pharmacology and pharmacokinetics in healthy subjects
Organon LLC
Research (3 studies)
SAPHRIS (asenapine) prescribing information: clinical pharmacology and pharmacokinetics in healthy subjects
Organon LLC
Quantification of asenapine and three metabolites in human plasma using liquid chromatography-tandem mass spectrometry with automated solid-phase extraction: application to a phase I clinical trial with asenapine in healthy male subjects.
Kaufmann B, Spengler J, Maier G, et al.
Asenapine pharmacokinetics and safety after single and multiple sublingual doses in healthy volunteers
McIntyre RS, Cohen A, et al.
Community updates
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