Use of asenapine as add-on therapy in the treatment of bipolar disorder: A comprehensive review and case series

Bernardo Dell'Osso, Laura Cremaschi, Maria Carlotta Palazzo, Gregorio Spagnolin, Alma Cattaneo, Benedetta Grancini, Matteo Maggi, Alfredo Carlo Altamura

Research output: Contribution to journalArticlepeer-review


Introduction: Several randomized controlled trials (RCTs), conducted in schizophrenic and bipolar patients, have documented the efficacy and tolerability of asenapine as monotherapy both for short- and long-term treatment. However, evidence on its augmentative use is more limited and related to the manic/mixed phase of bipolar disorder (BD).Areas covered: The present article reviews augmentative asenapine efficacy and safety/tolerability in the treatment of BD. It also includes some original cases of bipolar patients treated with add-on asenapine in the short- and long-term.Expert opinion: To date, only a single RCT with manic/mixed patients with partial response to mood-stabilizer monotherapy supports the efficacy and safety/tolerability of augmentative asenapine to lithium/valproate, both in acute and long-term treatment. Additionally, two case reports confirm the overall effectiveness of augmentative asenapine to clozapine and valproate. Our case series, consisting of 4 bipolar patients treated with adjunctive asenapine to mood stabilizers and atypical antipsychotics-with treatment duration ranging from 1 to 14 months-provided clinical results that are consistent with literature data. Taken as a whole, available evidence seems to support the efficacy and safety of adjunctive asenapine in bipolar patients, though additional studies with active comparators are requested to confirm the current body of evidence.

Original languageEnglish
Pages (from-to)1199-1208
Number of pages10
JournalExpert Opinion on Drug Safety
Issue number9
Publication statusPublished - 2014


  • Add-on therapy
  • Asenapine
  • Bipolar disorder
  • Efficacy
  • Tolerability

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)


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