Briefing Note - aripiprazole (Ablify)

SMC did not accept aripiprazole for use within NHSScotland to treat moderate to severe manic episodes in bipolar I disorder and to prevent a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

• Bipolar I disorder is a mental illness that causes extreme mood swings. Patients with this disease suffer from manic and depressive episodes, as well as having periods where they are symptom free. Symptoms of a manic episode include feeling ‘high’, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In a depressive phase, patients may suffer from lasting sadness or empty mood, loss of interest in activities once enjoyed, difficulty in concentrating, sleep disturbance and overwhelming feelings of worthlessness, guilt and hopelessness that often lead to thoughts of suicide or death.
• Aripiprazole is one of a group of medicines known as atypical antipsychotics, which help to stabilise mood. It is given as a tablet once daily.
• Short-term studies showed that aripiprazole was better than placebo at reducing manic symptoms and as good at maintaining a treatment effect as other comparators at the end of a three-month period. Over 6 months, aripiprazole was also better than placebo at preventing relapse.
• The most common side effects of aripiprazole are headache, nausea, anxiety, depression, nervousness, akathesia (inner restlessness), insomnia and weight gain.
• SMC decided not to accept aripiprazole as second-line treatment because aripiprazole was no more effective than the comparators in the analysis and the benefits did not outweigh the extra cost.