Abilify

(aripiprazole)

Forms/Strengths

• Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg
• Orally Disintegrating Tablets (Abilify ODT): 10 mg, 15 mg
• Oral Solution: 1 mg/mL

Dosing

• Age: >6 y/o

  • Irritability Associated with Autistic Disorder: 6-17 years

  • Bipolar I Disorder (Acute Mania/Mixed): 10-17 years, adults

  • Schizophrenia: 13+ years, adults

  • Tourette’s Disorder: 6-17 years

• Onset: Variable; clinical effect typically within days to weeks for mood/behavioral symptoms
• Duration: ~75 hours (half-life); steady-state typically achieved within 1–2 weeks
  
• Considerations: Monitor for EPS, metabolic and cardiovascular changes, assess behavioral shifts (especially in ADHD/mood dysregulation), and counsel families on potential side effects and gradual titration.
• Initial Dose: 

  • Autism: 2 mg/day

  • Bipolar: 2-5 mg/day (pediatrics), 10-15 mg/day (adults)

  • Schizophrenia: 2 mg/day titrated to 10-15 mg/day

  • Tourette’s: 2 mg/day

• Titration: Increase dose every 1–2 weeks
• Max Dose:

  Indication	Pediatric Max Dose	Adult Max Dose
  Autism	15 mg/day	N/A
  Bipolar I	30 mg/day	30 mg/day
  Schizophrenia	30 mg/day	30 mg/day
  Tourette’s	20 mg/day (6-12 y/o), 30 mg (13-17 y/o)	N/A

Quick Facts

• Partial agonist at dopamine D2 & serotonin 5-HT1A; antagonist at 5-HT2A receptors
• Modulates neurotransmission to stabilize mood and reduce psychotic symptoms
• Approved for reducing irritability and tantrums in children with autistic disorder
• Effective as adjunctive therapy in major depressive disorder
• Useful in controlling manic symptoms in bipolar I disorder and reducing motor/vocal tics in Tourette's Disorder
• Off-label benefits include use in ADHD-related aggression, disruptive behavior, and impulsivity
• Lower risk of EPS and metabolic burden compared to many first-generation and some second-generation antipsychotics (e.g., olanzapine, clozapine)
• Common side effects: akathisia, restlessness, insomnia, nausea, headache, weight gain, constipation
• Use with caution in patients with cardiovascular/metabolic risks
  

Indications

• Irritability Associated with Autistic Disorder (ICD-10: F84.0): Reduces aggression and tantrums.
• Major Depressive Disorder, Adjunctive Use (ICD-10: F32.x / F33.x): Enhances antidepressant effects.
• Schizophrenia (ICD-10: F20.x): Reduces delusions and hallucinations.
• Bipolar I Disorder (ICD-10: F31.x): Controls manic episodes and stabilizes mood.
• Tourette’s Disorder (ICD-10: F95.2): Reduces motor and vocal tics.

Off-Label Uses

• Generalized Anxiety Disorder (ICD-10: F41.1): Sometimes used adjunctively in refractory cases
• Post-Traumatic Stress Disorder (ICD-10: F43.10): May benefit select patients not responding to first-line treatments
• Borderline Personality Disorder (ICD-10: F60.3): May help reduce impulsivity and emotional dysregulation
• Behavioral Control in ADHD/Disruptive Behavior: Although not FDA-approved for this use, aripiprazole is often considered in pediatric patients with significant aggression or impulsivity when first-line ADHD treatments are insufficient
  

How to Take

• Administration:

  • Can be taken with or without food
  • Orally Disintegrating Tablets (ODT): Place on the tongue and allow to dissolve; do not chew or crush
  • Oral Solution: Measure accurately with a dosing syringe or cup
  • Take at the same time each day for consistency in drug levels

• Missed Dose:

  • Take as soon as possible unless it is near the next scheduled dose; do not double up

• Discontinuation:

  • Taper gradually when discontinuing to avoid withdrawal effects or rebound behavioral symptoms
    

Side Effects

• • Common:

    • Akathisia, restlessness
    • Fatigue, drowsiness
    • Nausea, vomiting
    • Dizziness, constipation

  • Serious:

    • Black Box Warnings: Increased mortality in elderly patients with dementia-related psychosis; increased suicidality in children/young adults with major depressive disorder
    • Tardive dyskinesia (involuntary facial, tongue, or body movements; risk increases with long-term use)
    • Neuroleptic malignant syndrome (high fever, muscle rigidity, confusion, altered consciousness, autonomic instability; rare but life-threatening)
    • Hyperglycemia and related complications (ketoacidosis, diabetic coma)
    • Orthostatic hypotension
    • Seizures/convulsions
    • Low white blood cell count
    • Laryngeal spasm and dystonic reactions (pharynx, hypopharynx, tongue)
    • Compulsive behaviors (gambling, binge eating, shopping, sexual urges)
    • Allergic reactions (rash, hives, swelling, difficulty breathing/swallowing)
    • Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis (stroke, TIA)
      

Monitoring / Labs

• Metabolic Effects: Monitor weight, fasting glucose, and lipid profiles regularly.
• Psychiatric Symptoms: Watch for worsening mood, suicidal thoughts, or unusual behavior.
• Tardive Dyskinesia: Assess for abnormal involuntary movements periodically.
• Blood Pressure: Monitor for orthostatic changes, especially in older adults.
• Baseline and Routine Monitoring:
  • Fasting glucose and lipid profile.
  • CBC (if history of leukopenia/neutropenia).
• Others: Monitor prolactin if symptoms of hyperprolactinemia occur.

Education

• When to Call the Doctor:
  • Signs of allergic reaction (rash, swelling, difficulty breathing).
  • High fever, muscle stiffness, or confusion (possible Neuroleptic Malignant Syndrome).
  • Uncontrolled movements of face, tongue, arms, or legs (possible Tardive Dyskinesia).
  • Sudden mood changes, agitation, suicidal thoughts.
  • Severe dizziness or fainting.
  • Excessive thirst, frequent urination, unexplained weight loss (possible hyperglycemia).

• Safety Tips:

  • Avoid alcohol and CNS depressants, as they may enhance sedation.
  • Caution with activities requiring alertness (e.g., driving) until individual response is known.
  • Slow positional changes to prevent orthostatic hypotension.
  • Maintain hydration and monitor for heat intolerance.
  • Tapering may be necessary before discontinuation to prevent withdrawal effects.

• Parent Tips for Pediatric Patients:

  • Monitor for behavioral changes (e.g., aggression, restlessness, suicidal ideation).
  • Encourage nutrient-dense meals to counteract potential weight gain.
  • Watch for sedation-related school performance issues.
  • Communicate with teachers and caregivers regarding behavioral or academic changes.
  • Ensure adherence; skipping doses may reduce symptom control.

Additional Information

• Contraindications:
  • Hypersensitivity to aripiprazole or any component of the formulation.
• Pregnancy: May cause extrapyramidal/withdrawal symptoms in neonates; use if benefits > risks (limited data)
• Lactation: Excreted in breast milk; not recommended.
• Drug Interactions:
  • CYP3A4 and CYP2D6 inhibitors (e.g., fluoxetine, ketoconazole) may increase aripiprazole levels.
  • CYP3A4 inducers (e.g., carbamazepine, rifampin) may decrease efficacy.
  • May potentiate effects of antihypertensives, leading to hypotension.
  • Caution with dopamine agonists or antagonists due to possible pharmacodynamic interactions.
    

References

1. FDA. Abilify (aripiprazole) Full Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/
2. DailyMed: Aripiprazole Monograph. https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=aripiprazole
3. MedlinePlus. Aripiprazole Drug Information. https://medlineplus.gov/druginfo/meds/a603012.html
4. Otsuka Pharmaceutical. Abilify (aripiprazole) Prescribing Information. https://www.otsuka-us.com/
5. GoodRx. Abilify Side Effects. https://www.goodrx.com/abilify/abilify-side-effects
6. NAMI. Aripiprazole Lauroxil Information. https://www.nami.org/
7. FDA. Abilify Safety and Utilization Review. https://www.fda.gov/media/107289/download
8. FDA. Abilify Medication Guide. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016MedG.pdf