Long-term flexible dose administration of sublingual asenapine was generally well tolerated in pediatric patients with a manic or mixed episode associated with bipolar I disorder.

Fifteen percent of patients discontinued due to treatment-emergent adverse events; clinically significant weight gain was experienced by 34.8 % of patients.

Among the predefined treatment-emergent adverse events of interest, the combination of somnolence, sedation, and hypersomnia was most frequent (42.4 % of patients).