What is the recommended dosage and treatment protocol for Abilify (aripiprazole)?

Aripiprazole (Abilify) Dosing and Treatment Protocol

For adult schizophrenia, start aripiprazole at 10-15 mg once daily without titration, as this is the FDA-approved target dose with demonstrated efficacy in the 10-30 mg/day range, though doses above 15 mg/day provide no additional benefit. 1

Adult Schizophrenia Dosing

Starting and Target Dose:

• Begin at 10 or 15 mg once daily without regard to meals 1
• No titration is necessary—patients can start at the target dose 1, 2
• Effective dose range: 10-30 mg/day, though higher doses (20-30 mg) show no superiority over 10-15 mg 1, 3

Dose Adjustments:

• Wait at least 2 weeks before increasing dose, as this is the time needed to reach steady-state 1
• Full therapeutic effect may take 1-4 weeks to manifest 4
• The drug accumulates significantly—steady-state plasma concentrations are 4-fold higher on day 14 versus day 1 2

Maintenance Treatment:

• Continue at effective dose (typically 10-15 mg/day) 1
• Periodically reassess need for ongoing treatment 1
• Efficacy maintained for up to 52 weeks in clinical trials 2

Adolescent Schizophrenia (Ages 13-17)

Titration Schedule:

• Day 1-2: 2 mg/day 5, 1
• Day 3-4: 5 mg/day 5
• Day 5 onward: 10 mg/day (target dose) 5, 1
• Subsequent increases: 5 mg increments if needed 1
• The 30 mg/day dose showed no additional efficacy over 10 mg/day 1

Special Populations and Dose Adjustments

Elderly Patients:

• Use lower starting doses 5
• Monitor closely for adverse effects given increased sensitivity 5

Hepatic Impairment:

• Use lower starting doses 5

CYP450 Drug Interactions (Critical):

• CYP2D6 poor metabolizers or strong CYP2D6 inhibitors: Reduce aripiprazole dose by 50% 1
• Strong CYP3A4 inhibitors: Reduce aripiprazole dose by 50% 1
• Strong CYP3A4 inducers: Double the aripiprazole dose 1
• When the interacting drug is discontinued, return to original dose over 1-2 weeks 1
• Common CYP2D6 inhibitors include paroxetine, fluoxetine, quinidine 6
• Common CYP3A4 inhibitors include ketoconazole, clarithromycin 1
• Common CYP3A4 inducers include carbamazepine, rifampin 1

Other Psychiatric Indications

Autism Spectrum Disorder (Ages 6-17):

• Dose range: 5-15 mg/day 5
• Response rate: 56% at 5 mg versus 35% on placebo 5
• Common side effects: somnolence, weight gain, drooling, tremor, fatigue, vomiting 5

Clozapine Augmentation for Treatment-Resistant Schizophrenia:

• Aripiprazole can augment clozapine when positive symptoms persist 5
• Starting dose: 5 mg daily 6
• The Finnish guidelines specifically note that combining aripiprazole with another antipsychotic may reduce negative symptoms 7

PTSD-Related Nightmares:

• Dose range: 15-30 mg/day 5
• Expect substantial improvement within 4 weeks 5

Safety Monitoring and Side Effects

Common Adverse Effects:

• Insomnia, anxiety, headache, agitation, akathisia 2
• Monitor particularly for akathisia and restlessness in first few weeks 6
• Headache, agitation, anxiety, insomnia, dizziness, drowsiness 6

Favorable Safety Profile:

• Low risk of extrapyramidal symptoms compared to haloperidol 2, 8
• Minimal weight gain (comparable to haloperidol, less than olanzapine) 2
• Low propensity for hyperprolactinemia 2
• Minimal QT prolongation at therapeutic doses 2
• Tardive dyskinesia incidence: 0.2% (similar to placebo) 2

Critical Precautions:

• Increased mortality in elderly patients with dementia-related psychosis 8
• Risk of neuroleptic malignant syndrome 8
• Postural hypotension possible 8
• Monitor for serotonin syndrome when combining with serotonergic agents like sertraline, especially in first 24-48 hours after dose changes 6

Pharmacokinetic Considerations

Absorption and Distribution:

• Time to peak concentration: 3 hours 2
• Oral bioavailability: 87% 2
• Elimination half-life: ~75 hours for aripiprazole, ~94 hours for active metabolite dehydro-aripiprazole 2, 4

• 99% protein bound 2

Clinical Implications:

• Long half-life means once-daily dosing is appropriate 1
• Steady-state achieved in 14 days 2, 4
• Active metabolite contributes to therapeutic effect 9, 2