What is Abilify (ARIPiprazole)?

Aripiprazole (Abilify): Uses, Mechanism, Side Effects, and Dosage

Mental health conditions such as schizophrenia, bipolar disorder, and depression can significantly affect a persons thoughts, emotions, and daily life. Many patients describe feeling trapped by racing thoughts, mood swings, or a sense of emotional numbness. Aripiprazole, commonly known by the brand name Abilify, helps restore balance to brain chemistry, improving emotional stability and overall functioning.

Aripiprazole belongs to a class of medications known as atypical antipsychotics. Unlike older antipsychotics that often caused heavy sedation or stiffness, Aripiprazole offers a more balanced and targeted approach to regulating dopamine and serotoninkey neurotransmitters that influence mood and behavior. It is widely used as a first-line or adjunctive treatment for a variety of psychiatric conditions and has become an important option in modern psychiatry due to its effectiveness and generally favorable side-effect profile.

What Does Aripiprazole Do?

Aripiprazole is prescribed to treat mental health disorders that involve disturbances in mood, thought, or perception. These include:

Schizophrenia: Helps reduce hallucinations, delusions, and disorganized thinking.
Bipolar I disorder: Stabilizes mood and prevents manic or mixed episodes.
Major depressive disorder (MDD): Used alongside antidepressants when standard therapy is insufficient.
Tourettes disorder: Reduces tics in children and adolescents.
Irritability associated with autism spectrum disorder: Helps manage agitation and aggression.

Clinical studies show that patients on Aripiprazole often experience fewer relapses, improved mood regulation, and better social functioning compared to those who discontinue therapy (FDA, 2023; Mayo Clinic, 2024).

From a patients perspective, improvement may feel like regaining control over emotions, thinking more clearly, participating in daily activities, and rebuilding confidence.

How Does Aripiprazole Work?

Aripiprazole works by modulating dopamine and serotonin activity in the brain rather than completely blocking or boosting these neurotransmitters. Specifically, it acts as a partial agonist at dopamine D? and serotonin 5-HT?A receptors while blocking serotonin 5-HT?A receptors.

This means it helps stabilize brain signalingreducing excessive dopamine activity linked to psychosis or mania while enhancing dopamine function where levels are too low, such as in depression.

Clinically, this dopamine stabilizing property makes Aripiprazole unique among antipsychotics. It helps relieve symptoms such as hallucinations, irritability, and impulsivity without the heavy sedation or metabolic burden often associated with older medications.

Research also suggests that Aripiprazole may improve cognitive and emotional flexibility, helping patients engage more fully in therapy and daily routines (NIH, 2024).

Aripiprazole Side Effects

Most people tolerate Aripiprazole well, but as with all medications, side effects can occur. These are usually mild and manageable, especially under close medical supervision.

Common Side Effects

Drowsiness or restlessness
Dizziness or lightheadedness
Nausea or constipation
Mild weight gain (less than with many other antipsychotics)
Insomnia or anxiety

Serious Side Effects (Less Common)

Extrapyramidal symptoms (uncontrollable movements or tremors)
Metabolic changes (high blood sugar, cholesterol, or triglycerides)
Neuroleptic malignant syndrome (rare but life-threatening muscle rigidity and fever)
Tardive dyskinesia (involuntary facial or body movements with long-term use)
Suicidal thoughts, particularly in adolescents and young adults

Patients should contact their healthcare provider immediately if they experience muscle stiffness, high fever, irregular heartbeat, or suicidal thoughts. Those with a history of heart rhythm disorders, diabetes, or seizures should discuss these conditions with their doctor before starting Aripiprazole (MedlinePlus, 2024).

What Is the Dosage of Aripiprazole?

Aripiprazole is available in several forms, including oral tablets, orally disintegrating tablets, liquid solution, and long-acting injectable formulations. The injectable versions, such as Abilify Maintena or Aristada, provide steady medication levels for weeks or monthsuseful for patients who have difficulty maintaining daily dosing.

The dosage depends on the condition being treated, patient age, and individual response. Physicians typically start with a low dose and adjust gradually to achieve optimal symptom control.

During Treatment, Doctors Often Monitor:

Weight and metabolic health (blood sugar and lipid levels)
Neurological side effects (muscle stiffness, tremors, or restlessness)
Mood changes or suicidal thoughts, especially early in therapy
Liver function tests in select patients

For older adults or those with liver or kidney impairment, careful dose adjustment may be necessary to minimize risks. Regular follow-ups and open communication with the healthcare provider help ensure safe and effective long-term use.

Does Aripiprazole Have a Generic Version?

Yes. Aripiprazole is available as a generic medication, approved by the FDA and proven to be equally safe and effective as the brand-name version Abilify. Generic Aripiprazole is widely available in pharmacies and comes in multiple dosage forms, including tablets, oral solutions, and injectable preparations.

Using the generic form can make treatment more affordable without compromising quality or therapeutic effect. However, the long-acting injectable versions (like Abilify Maintena and Aristada) may still be under brand names, as they involve specific delivery systems and formulations.

Conclusion

Aripiprazole is a well-established and versatile medication that helps manage a range of mental health disorders by restoring chemical balance in the brain. Its unique action as a dopamine and serotonin stabilizer allows for effective symptom control with a lower risk of heavy sedation or weight gain compared to many other antipsychotics.

While it may take several weeks for the full benefits to appear, consistent use under medical guidance can lead to significant improvements in mood, thought clarity, and daily functioning.

Ultimately, Aripiprazole can be a life-changing therapy for individuals living with schizophrenia, bipolar disorder, depression, or related conditions. When prescribed and monitored by a qualified healthcare provider, it provides a path toward better mental stability, improved quality of life, and renewed hope.

References

U.S. Food and Drug Administration (FDA). (2023). Aripiprazole: Drug label and prescribing information. https://www.fda.gov/
Mayo Clinic. (2024). Aripiprazole (oral route) description and precautions. https://www.mayoclinic.org/
MedlinePlus. (2024). Aripiprazole: Drug Information. https://medlineplus.gov/
National Institutes of Health (NIH). (2024). Mechanism and clinical applications of atypical antipsychotics. https://www.nih.gov/

Brand Information

ABILIFY (ARIPIPRAZOLE)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber

1INDICATIONS AND USAGE

ABILIFY (aripiprazole) Tablets are indicated for the treatment of:

Schizophrenia
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
Adjunctive Treatment of Major Depressive Disorder
Irritability Associated with Autistic Disorder
Treatment of Tourette's Disorder

2DOSAGE FORMS AND STRENGTHS

ABILIFY

3CONTRAINDICATIONS

ABILIFY is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis

4ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of the labeling:

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Cerebrovascular Adverse Events, Including Stroke
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults
Neuroleptic Malignant Syndrome (NMS)
Tardive Dyskinesia
Metabolic Changes
Pathological Gambling and Other Compulsive Behaviors
Orthostatic Hypotension
Falls
Leukopenia, Neutropenia, and Agranulocytosis
Seizures/Convulsions
Potential for Cognitive and Motor Impairment
Body Temperature Regulation
Suicide
Dysphagia

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions in adult patients in clinical trials (≥10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

The most common adverse reactions in the pediatric clinical trials (≥10%) were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased.

ABILIFY has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately 7,619 patient-years of exposure to oral ABILIFY and 749 patients with exposure to aripiprazole injection. A total of 3,390 patients were treated with oral ABILIFY for at least 180 days and 1,933 patients treated with oral ABILIFY had at least one year of exposure.

ABILIFY has been evaluated for safety in 1,686 pediatric patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's Disorder and who had approximately 1,342 patient-years of exposure to oral ABILIFY. A total of 959 pediatric patients were treated with oral ABILIFY for at least 180 days and 556 pediatric patients treated with oral ABILIFY had at least one year of exposure.

The conditions and duration of treatment with ABILIFY (monotherapy and adjunctive therapy with antidepressants or mood stabilizers) included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.

4.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ABILIFY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), blood glucose fluctuation, drug reaction with eosinophilia and systemic symptoms (DRESS), hiccups, oculogyric crisis, pathological gambling, and fecal incontinence.

5OVERDOSAGE

MedDRA terminology has been used to classify the adverse reactions.

6DESCRIPTION

Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY

ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

7CLINICAL STUDIES

Efficacy of ABILIFY was established in the following adequate and well-controlled trials:

Four short-term trials and one maintenance trial in adult patients and one short-term trial in adolescents (ages 13 to 17 years) with schizophrenia
Four short-term monotherapy trials and one 6-week adjunctive trial in adult patients and one short-term monotherapy trial in pediatric patients (ages 10 to 17 years) with manic or mixed episodes
One maintenance monotherapy trial and one maintenance adjunctive trial in adult patients with bipolar I disorder
Two short-term trials in adult patients with MDD who had an inadequate response to antidepressant therapy during the current episode
Two short-term trials in pediatric patients (ages 6 to 17 years) for the treatment of irritability associated with autistic disorder
Two short-term trials in pediatric patients (ages 6 to 18 years) with Tourette's Disorder

8PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (

9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-006-13

10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-007-13

11PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-008-13

12PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-009-13

13PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-010-13

14PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

30 Tablets NDC 59148-011-13

ARIPiprazole