Understanding Depression
Everyone feels sad or less interested in life occasionally. But if you don't have the energy for your favorite activities, or they don't give you the satisfaction they used to, or if you feel sad or empty most of the day, every day, it could be depression. Depression is a real and serious illness that may affect your appetite, your sleep patterns, the way you feel about yourself, and the way you think about things. It can make you less inclined to engage in once-enjoyable activities or even disinterested in life in general. It may occur once, but for many people it can occur several times in their lives. A common mental illness, it is estimated that depression affects about 14 million Americans in a given year or approximately 1 out of 6 adults over a lifetime.
What causes depression?
While many things may contribute to depression, its exact cause is not fully understood. Contributors to depression could be genetic, biochemical, environmental, psychological, or any combination of these factors. Biologically, depression is thought to involve an imbalance of naturally occurring chemicals in the brain. These chemicals are called "neurotransmitters," and they help nerve cells communicate with each other by sending messages. The three key neurotransmitters thought to be involved in depression are serotonin, norepinephrine, and dopamine. When someone is depressed, the nerve cells cannot communicate effectively. If not enough neurotransmitters are available, certain nerve messages will not be properly communicated. This is thought to result in feelings of sadness, disinterest, and other symptoms of depression.
ABILIFY is indicated only in adults with major depressive disorder (MDD).
IMPORTANT SAFETY INFORMATION and INDICATION for ABILIFY® (aripiprazole)
INDICATION: ABILIFY (aripiprazole) is indicated for:
- Use as an add-on treatment to antidepressants for major depressive disorder in adults
IMPORTANT SAFETY INFORMATION:
Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with atypical antipsychotic medicines, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).
Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient's healthcare professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).
Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.
Serious side effects may include:
- An increased risk of stroke and ministroke has been reported in clinical studies of elderly people with dementia-related psychosis
- Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
- Abnormal or uncontrollable movements of face, tongue, or other parts of body. These may be signs of a serious condition called tardive dyskinesia (TD), which could become permanent
- If you have diabetes, or risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger your blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it.
Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.
ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.
Medicines like ABILIFY can impact your body's ability to reduce body temperature, you should avoid overheating and dehydration.
ABILIFY and medicines like it have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.
Tell your healthcare professional if you have a history of or are at risk for seizures, or are pregnant or intend to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take, since there are some risks for drug interactions.
While taking ABILIFY, avoid:
- Drinking alcohol
- Breast-feeding an infant
Most common side effects (≥10%) from all clinical trials involving adults or pediatric patients include:
ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness.
PEDIATRIC PATIENTS (10-17 years): Extrapyramidal Disorder (for example, uncontrolled movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness), headache, sleepiness, and nausea.
It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasm or contraction which may be signs of a condition called dystonia.
For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.
For patients with phenylketonuria or PKU, ABILIFY DISCMELT® (aripiprazole) contains phenylalanine.
If you have any questions about your health or medicines, talk to your healthcare professional.
Please see U.S. FULL PRESCRIBING INFORMATION including Boxed WARNINGS and Medication Guide.
