Aripiprazole

Conditions Treated

Aripiprazole is an atypical antipsychotic medication used to manage symptoms of several mental health and neurological conditions. It works by affecting certain natural substances in the brain.

Schizophrenia

It is used to treat schizophrenia in adults and children 13 years of age and older. Schizophrenia is a condition that can cause disturbed thinking, loss of interest in life, and strong or inappropriate emotions.

Bipolar I Disorder

Aripiprazole is used to treat manic or mixed episodes (periods of abnormally high, excited, or irritable mood) in adults and children 10 years of age and older. It may be prescribed alone or in combination with other medications.

Major Depressive Disorder

In adults, aripiprazole is used as an add-on treatment for depression when antidepressant medications alone are not sufficient to manage symptoms.

Irritability Associated with Autistic Disorder

It is used to treat symptoms of irritability in children and teenagers (ages 6 to 17) with autistic disorder. These symptoms may include:

• Aggression toward others
• Deliberate self-injury
• Temper tantrums
• Quickly changing moods

Tourette's Disorder

Aripiprazole is used to treat Tourette's disorder in children and adolescents between the ages of 6 and 18.

Mechanism of Action

Aripiprazole belongs to a class of medications known as atypical antipsychotics. While the exact way it works for all conditions is not fully understood, it is believed to help restore the balance of certain natural substances in the brain called neurotransmitters.

This medication primarily affects two key neurotransmitters that are responsible for transmitting signals between nerve cells:

• Dopamine: This chemical is involved in how the brain processes information, experiences pleasure, and regulates mood.
• Serotonin: This chemical helps regulate mood, sleep, and anxiety.

Aripiprazole is often considered a stabilizer. Unlike some older medications that only block these chemicals, aripiprazole can adjust their activity depending on the brain's needs. If levels of these chemicals are too high in certain areas, the medication helps lower their effect. If levels are too low in other areas, it can help increase their activity. By balancing these levels, the medication helps reduce symptoms such as hallucinations, disorganized thinking, and extreme mood swings.

Common Side Effects

Commonly reported side effects of aripiprazole include:

• Nausea and vomiting
• Constipation
• Headache
• Dizziness or lightheadedness
• Drowsiness or fatigue
• Restlessness or an inability to sit still (akathisia)
• Anxiety
• Weight gain
• Blurred vision
• Increased saliva or drooling

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Movement disorders: Uncontrolled or repetitive movements of the face, tongue, or limbs, which may become permanent.
• Neuroleptic Malignant Syndrome: A rare but life-threatening reaction characterized by high fever, muscle rigidity, confusion, sweating, and irregular heartbeat.
• Impulse control issues: New or intense urges to gamble, shop, eat, or engage in sexual activities that are difficult to control.
• High blood sugar: Symptoms such as increased thirst, frequent urination, extreme hunger, and weakness.
• Difficulty swallowing: Problems with the swallowing reflex that could lead to food or liquid entering the lungs.
• Low white blood cell count: Fever, sore throat, or other persistent signs of infection.
• Seizures: Sudden, uncontrolled electrical disturbances in the brain.
• Orthostatic hypotension: A sudden drop in blood pressure that causes dizziness or fainting when standing up from a sitting or lying position.

Boxed Warnings

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

Antidepressants and antipsychotics may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Patients of all ages starting therapy should be monitored closely for worsening symptoms, suicidal thoughts, or unusual changes in behavior.

Impulse Control Problems

The FDA has issued warnings that aripiprazole may cause intense, uncontrollable urges to gamble, binge eat, shop, or engage in sexual activity. These urges can occur even if the person did not have these behaviors before starting the medication. These impulses typically stop once the medication is discontinued or the dose is reduced.

Serious Reactions

• Neuroleptic Malignant Syndrome (NMS): This is a rare but life-threatening condition associated with antipsychotic use. Symptoms include high fever, stiff muscles, confusion, and changes in pulse or blood pressure.
• Tardive Dyskinesia: This condition causes involuntary, repetitive body movements, such as grimacing, lip-smacking, or eye blinking. In some cases, these movements may become permanent.
• Metabolic Changes: Treatment may lead to high blood sugar (hyperglycemia), increased cholesterol and triglyceride levels, and significant weight gain. Healthcare providers may monitor blood sugar and weight regularly during treatment.

Other Precautions

Aripiprazole may cause orthostatic hypotension, which is a sudden drop in blood pressure that leads to dizziness or lightheadedness when standing up. It can also impair the body's ability to regulate its core temperature, increasing the risk of overheating during heavy exercise or exposure to extreme heat. Because the medication can cause drowsiness or impair judgment and motor skills, caution is advised when driving or operating heavy machinery until the drug's effects are fully understood.

Pregnancy

If you are pregnant or planning to become pregnant, discuss the risks and benefits of using aripiprazole with your healthcare provider. Taking antipsychotic medications during the last three months of pregnancy may cause problems in the newborn after delivery. These issues may include:

• Withdrawal symptoms
• Breathing or feeding difficulties
• Tremors or muscle stiffness
• Extreme sleepiness or agitation

There is a pregnancy registry for individuals who take psychiatric medications while pregnant. This registry helps health professionals monitor the safety of these drugs for both the parent and the baby.

Breastfeeding

Aripiprazole can pass into breast milk. It is important to talk to your doctor if you are breastfeeding or planning to breastfeed to determine the best course of action for you and your infant.

Oral Formulations

Aripiprazole is most commonly prescribed in oral formats for daily use:

• Tablets: Standard oral tablets available in various strengths.
• Orally Disintegrating Tablets: These tablets are designed to dissolve on the tongue and should be taken immediately after opening the blister pack.
• Oral Solution: A liquid form of the medication, often used for patients who have difficulty swallowing pills.

Injectable Formulations

This medication is also available as an injection, which is typically administered by a healthcare professional in a medical setting:

• Immediate-release injection: Used for the acute treatment of certain symptoms.
• Extended-release injectable suspension: Long-acting versions of the medication that are administered at intervals of several weeks or months.

The specific form and strength prescribed depend on the condition being treated, the patient's age, and their response to the medication.

FDA Approval and Indications

Aripiprazole is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several specific conditions, including:

• Schizophrenia
• Manic or mixed episodes associated with bipolar I disorder
• Major depressive disorder (as an add-on treatment for patients already taking an antidepressant)
• Irritability associated with autistic disorder
• Tourette's disorder

Boxed Warnings

The FDA requires a boxed warning—its most serious level of caution—for aripiprazole due to the following risks:

• Dementia-Related Psychosis: Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
• Suicidal Thoughts and Behaviors: Antidepressants and certain antipsychotics may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Patients and caregivers should monitor for any unusual changes in mood or behavior, especially when first starting the medication or changing the dose.

Safety Communications

In 2016, the FDA issued a safety communication warning that aripiprazole is associated with compulsive or uncontrollable urges to gamble, eat, shop, and engage in sexual activity. These impulse-control problems are reported to be rare but can result in harm to the patient and others if not recognized. These urges typically stop when the medication is discontinued or the dose is reduced.

Discontinuing Aripiprazole

It is important not to stop taking aripiprazole abruptly without consulting a healthcare provider. Stopping the medication suddenly can lead to several issues:

• Return of symptoms: The mental health condition being treated, such as schizophrenia or bipolar disorder, may worsen or return if the medication is stopped too quickly.
• Withdrawal effects: Patients may experience unpleasant physical or psychological symptoms when the drug is discontinued suddenly.

Safe Discontinuation

If you and your doctor decide to stop treatment, the dose is typically reduced gradually. This process, known as tapering, helps the body adjust and minimizes the risk of withdrawal effects. Always follow the specific schedule provided by your healthcare professional to ensure the medication is stopped safely.