Abilify

Approved Uses

Abilify is a medication prescribed to manage symptoms of various psychiatric and neurological conditions. It is used in both adults and children, depending on the specific diagnosis.

Schizophrenia

Abilify is used to treat schizophrenia in adults and children at least 13 years old. Schizophrenia is a chronic mental disorder that may cause hallucinations, delusions, and disordered thinking.

Bipolar I Disorder

This medication is used to treat manic or mixed episodes associated with bipolar I disorder. It may be used alone or in combination with other mood-stabilizing medications. It is approved for use in adults and children 10 years and older.

Major Depressive Disorder

In adults, Abilify is used as an add-on treatment for major depressive disorder. It is typically prescribed when an antidepressant alone is not providing enough relief from symptoms.

Irritability Associated with Autistic Disorder

Abilify is used to treat symptoms of irritability, such as aggression, mood swings, and self-injury, in children and adolescents aged 6 to 17 who have autistic disorder.

Tourette's Disorder

It is used to treat motor and vocal tics in children and adolescents aged 6 to 18 who have Tourette's disorder.

Mechanism of Action

Abilify (aripiprazole) belongs to a class of medications known as atypical antipsychotics. While the exact way it works is not fully understood, it is believed to help manage symptoms by affecting the activity of neurotransmitters in the brain.

Balancing Brain Chemicals

Neurotransmitters are natural chemicals that act as messengers between brain cells. Abilify primarily targets two of these chemicals:

• Dopamine: This chemical is involved in how the brain processes motivation, reward, and movement.
• Serotonin: This chemical helps regulate mood, sleep, and appetite.

Unlike some older antipsychotic medications that primarily block dopamine, Abilify acts as a partial agonist. This means it can either increase or decrease the activity of dopamine and serotonin depending on the levels already present in the brain. If levels of these chemicals are too high, the medication helps lower them; if levels are too low, it can help boost them. This stabilizing effect helps to normalize brain communication and improve symptoms associated with various mental health conditions.

Common Side Effects

The most frequently reported side effects of Abilify include:

• Nausea, vomiting, or constipation
• Headache or dizziness
• Drowsiness or feeling tired
• Increased appetite and weight gain
• Restlessness or an uncontrollable urge to move
• Blurred vision
• Excessive saliva or drooling
• Anxiety or trouble sleeping

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Uncontrolled muscle movements, particularly in the face, tongue, or other body parts
• Signs of high blood sugar, such as extreme thirst, frequent urination, or fruity-smelling breath
• Difficulty swallowing
• Seizures
• Signs of infection, such as fever or sore throat, which may indicate a low white blood cell count
• Difficulty regulating body temperature or feeling very hot

A rare but serious reaction called Neuroleptic Malignant Syndrome (NMS) can occur. Seek emergency care for high fever, stiff muscles, confusion, sweating, or changes in heart rate.

Impulse Control Problems

Abilify has been linked to new or intense urges that are difficult to control. These may include compulsive gambling, binge eating, excessive shopping, or increased sexual urges. These behaviors typically stop if the medication is adjusted or discontinued under medical supervision.

Boxed Warnings

Abilify includes two boxed warnings, which are the most serious safety alerts issued by the FDA:

• Increased mortality in elderly patients with dementia-related psychosis: Older adults with dementia-related psychosis who are treated with antipsychotic drugs face an increased risk of death. Abilify is not approved for the treatment of patients with dementia-related psychosis.
• Suicidal thoughts and behaviors: In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults. Patients of all ages who start this therapy should be monitored closely for worsening symptoms, suicidal thoughts, or unusual changes in behavior.

Impulse Control Problems

There have been reports of patients experiencing intense, uncontrollable urges while taking Abilify. These may include compulsive gambling, binge eating, excessive shopping, and increased sexual urges. Because patients may not recognize these behaviors as abnormal, it is important for caregivers and family members to watch for new or worsening urges.

Serious Neurological and Movement Conditions

Neuroleptic Malignant Syndrome (NMS)

NMS is a rare but potentially fatal reaction to antipsychotic medications. Symptoms can include high fever, muscle stiffness, confusion, sweating, and changes in heart rate or blood pressure.

Tardive Dyskinesia

This condition involves involuntary, repetitive body movements, such as grimacing or eye blinking. The risk of developing tardive dyskinesia may increase with the length of treatment and the total dose taken, and the condition can sometimes become permanent.

Metabolic Changes

Atypical antipsychotic drugs like Abilify can cause metabolic changes that may increase cardiovascular risk. These include:

• Hyperglycemia and Diabetes: Some patients may develop high blood sugar, which in extreme cases can lead to ketoacidosis, coma, or death. Regular blood sugar monitoring may be necessary for those with diabetes or risk factors for the disease.
• Dyslipidemia: Changes in cholesterol and triglyceride levels can occur.
• Weight Gain: Significant weight gain has been observed in patients taking Abilify and should be monitored regularly.

Other Precautions

• Orthostatic Hypotension: Abilify may cause a sudden drop in blood pressure when standing up, leading to dizziness, lightheadedness, or fainting.
• Low White Blood Cell Count: Some patients may experience a significant decrease in white blood cells, which can increase the risk of infection.
• Seizures: The medication should be used with caution in individuals with a history of seizures or conditions that lower the seizure threshold.
• Cognitive and Motor Impairment: Abilify may cause sleepiness or impair judgment, thinking, and motor skills.
• Body Temperature Regulation: The drug may interfere with the body's ability to reduce its core temperature, increasing the risk of overheating during strenuous exercise or exposure to extreme heat.
• Difficulty Swallowing: Antipsychotic use has been associated with esophageal dysmotility and aspiration.

Pregnancy

The use of Abilify during pregnancy requires careful consideration. Healthcare providers typically recommend using this medication only when the potential benefit to the mother justifies the potential risk to the developing fetus.

If Abilify is taken during the third trimester (the last three months) of pregnancy, the newborn may experience certain complications after birth. These symptoms may vary in severity and can include:

• Withdrawal symptoms
• Breathing problems
• Feeding difficulties
• Tremors or muscle stiffness
• Excessive sleepiness or fussiness

It is important not to stop taking Abilify suddenly without consulting a healthcare provider, as untreated mental health conditions can also pose risks to both the parent and the baby. There is a pregnancy registry available to monitor the health of individuals who take antipsychotic medications while pregnant.

Breastfeeding

Abilify passes into human breast milk. Because of the potential for side effects in a nursing infant, a decision should be made whether to discontinue breastfeeding or discontinue the drug. This decision should take into account the importance of the medication to the mother's health and the potential effects on the infant. Individuals are encouraged to discuss the risks and benefits of breastfeeding while taking this medication with their healthcare team.

Oral Formulations

Abilify is provided in multiple oral formats for daily use:

• Tablets: Standard tablets taken by mouth.
• Orally Disintegrating Tablets: These tablets are designed to dissolve quickly on the tongue and can be swallowed without additional liquid.
• Oral Solution: A liquid version of the medication for patients who prefer or require a non-solid form.
• Tablet with Sensor: A specialized oral tablet system that contains an ingestible sensor to track when the medication has been taken.

Injectable Formulations

Injectable versions of this medication are administered by healthcare professionals and include:

• Intramuscular Injection: An immediate-release liquid formulation for injection into the muscle.
• Extended-Release Injectable Suspension: A long-acting form of the medication administered by a healthcare provider that releases the drug slowly over time.

FDA Approval and Indications

Abilify (aripiprazole) is an FDA-approved prescription medication. It is indicated for the treatment of schizophrenia, manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for major depressive disorder. It is also approved to treat irritability associated with autistic disorder and Tourette's disorder in certain pediatric populations.

Boxed Warnings

The FDA has issued Boxed Warnings for Abilify regarding two significant safety concerns:

• Dementia-Related Psychosis: Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs face an increased risk of death. Abilify is not FDA-approved for treating patients with dementia-related psychosis.
• Suicidal Thoughts and Behaviors: While Abilify is not a traditional antidepressant, it is used to treat depression. Antidepressants have been shown to increase the risk of suicidal thoughts and actions in children, adolescents, and young adults.

Impulse-Control Warnings

The FDA has warned that Abilify may cause patients to experience intense, uncontrollable urges, particularly gambling, eating, shopping, and sexual urges. These impulse-control problems are rare but serious. According to regulatory safety communications, these behaviors usually resolve after the medication is stopped or the dosage is reduced.

Weight Gain and Abilify

Weight gain is a common side effect for people taking Abilify. While clinical studies suggest it may cause less weight gain than some other antipsychotic medications, it remains a significant concern for many patients.

How Abilify Affects Weight

The exact reason why Abilify causes weight gain is not fully understood, but it may involve changes in metabolism or appetite. The impact can differ between age groups:

• Adults: Many adults experience modest weight gain, though some may see more significant changes.
• Children and Adolescents: Pediatric patients are often more sensitive to the weight-related side effects of this medication and may gain weight more rapidly than adults.

Monitoring and Management

Because of the risk of weight gain, healthcare providers usually perform the following during treatment:

• Regularly check weight and body mass index (BMI).
• Monitor waist circumference.
• Order blood tests to check for changes in blood sugar (glucose) and cholesterol levels, as these can be affected by weight changes.

Patients are encouraged to maintain a healthy lifestyle, including a balanced diet and regular exercise, to help manage potential weight changes. If weight gain becomes a concern, it is important to speak with a doctor before making any changes to the medication schedule.