Armodafinil (Nuvigil) Risks, Warnings, and Complications

CONTROLLED SUBSTANCE: Armodafinil is a controlled substance (Schedule IV) due to a potential for abuse and dependence. This medication can cause a euphoric mood. Some people abuse it by taking increasingly large doses or more frequent doses to get a euphoric effect. Drug diversion (selling or giving the medication to others) has also been reported. 

Never take armodafinil without a physician’s advice. Do not obtain this medication from multiple physicians. 

DRUG ABUSE AND DEPENDENCE: People taking armodafinil can develop a physical dependence on it. They may experience withdrawal symptoms if the dose of the medication is reduced significantly all of a sudden or the medicine is discontinued abruptly. Withdrawal symptoms can include sweating, shakiness, chills, nausea, vomiting, fatigue, insomnia, muscle aches, headache, depression, aggression, confusion, heart rhythm abnormalities, convulsions, and suicidal thinking. 

Taking armodafinil can lead to tolerance over time. This means a person may have a decreased response to this medication after taking it for a period of time or higher doses may have the same effect as lower doses.

Drug abuse of armodafinil can increase the risk of an overdose. Signs of an overdose may include dizziness, headache, flushed skin, fast heart rate, fast breathing, dilated pupils, agitation, restlessness, hyperactivity, insomnia, anxiety, abdominal pain, nausea, decreased appetite, tremor, high blood pressure, chest pain, poor coordination, seizures, hallucinations, or delirium. 

Before starting armodafinil, tell your healthcare professional if you have a history of mental illness, including substance abuse. Take armodafinil exactly as prescribed by your doctor. Do not change the dose or dosing frequency without your doctor’s approval.

SERIOUS ALLERGIC REACTIONS: There are reports of life-threatening adverse reactions, including serious skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis, after the use of modafinil and armodafinil. This risk is higher in people under the age of 18 years. Armodafinil is not approved for use in children for any condition. 

A serious rash can occur anywhere from 1 day to 2 months after starting treatment with armodafinil. There are also reports of serious dermatologic reactions after prolonged use for 3 months. 

Stop taking armodafinil and seek emergency medical care at the first sign of a skin rash, hives, itching, blistering, peeling, or mouth ulceration.

DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS): Drug reaction with eosinophilia and systemic symptoms (DRESS) is a serious multi-organ hypersensitivity reaction that can involve the liver, kidneys, blood, heart, and muscles. This drug reaction can be life-threatening and requires hospitalization. 

Stop taking armodafinil and get emergency medical care if you develop a fever, rash, facial swelling, and/or swollen glands. These symptoms can resemble an acute viral infection. 

ANGIOEDEMA AND ANAPHYLAXIS REACTIONS: Angioedema (swelling under the skin) and anaphylaxis (throat closing) have been reported after taking Nuvigil (armodafinil). Stop taking the medicine and immediately talk with your doctor or go to the emergency room if you develop swelling of the face, eyes, lips, tongue, or throat, hoarseness, or trouble breathing or swallowing. 

CONTINUED SLEEPINESS: Armodafinil (Nuvigil) treatment may not completely cure excessive sleepiness. You may have persistent daytime sleepiness while on this medication. Your doctor will reassess you frequently to evaluate your response to the drug. Avoid driving or doing other potentially hazardous activities even if you feel more alert compared to before unless your doctor says you can. 

PSYCHIATRIC SYMPTOMS: Controlled trials have shown that taking Nuvigil (armodafinil) can cause irritability, nervousness, anxiety, and agitation. These side effects can be severe enough to require discontinuation of armodafinil (Nuvigil) treatment. Depression and suicidal ideation (thoughts of harming one’s self) have also been reported in clinical trials.

Tell your doctor if you have a history of mental illness such as depression, psychosis, bipolar depression, or mania. Stop taking armodafinil and call your doctor if you develop any new or unusual changes in mood or behavior, such as abnormal excitement or frenzied mood, aggression, delusions, hallucinations, or suicidal ideation. 

EFFECTS ON CONCENTRATION: Armodafinil affects the central nervous system (CNS) and can potentially affect thinking, judgment, and motor skills. Be careful while driving, operating machinery, and doing other dangerous activities while you are on this medication. 

CARDIOVASCULAR RISKS: Clinical studies have shown that modafinil, which is very similar to armodafinil, can cause cardiovascular side effects such as chest pain, fast or irregular heartbeat, shortness of breath, and ECG changes. Your doctor will monitor your blood pressure when you start treatment and during treatment with armodafinil because this drug can cause high blood pressure.

Tell your doctor if you have a history of heart problems, including hypertension, mitral valve prolapse, and left ventricular hypertrophy. Seek immediate medical attention if you develop chest pain or a fast or irregular heartbeat.