Risperidone (Risperdal) is now approved as monotherapy or in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder (bipolar mania). In clinical trials, patients who received risperidone in doses of 1 mg/d to 6 mg/d experienced significantly greater symptom improvements than those in the control groups.

In the clinical studies, all doses of risperidone were generally well tolerated. The most common side effects in monotherapy studies included extrapyramidal symptoms, sleepiness, dyspepsia, nausea, abnormal vision, and increased saliva. In combination therapy studies, common side effects included sleepiness, dizziness, parkinsonism, increased saliva, akathisia, abdominal pain, and urinary incontinence.

A long-acting injection formulation of risperidone (Risperdal Consta) is now available for the treatment of schizophrenia. Risperdal Consta is the first and only long-acting atypical antipsychotic approved by the FDA for this indication.

Risperdal Consta is available in 25 mg, 37.5 mg, and 50 mg dose units.

In clinical trials, Risperdal Consta was generally well tolerated. The most common adverse events were somnolence, akathisia, parkinsonism, dyspepsia, constipation, dry mouth, fatigue, and weight increase.

Consult product labeling for detailed prescribing instructions.