Armodafinil Tablets

What is this medication?

ARMODAFINIL (ar moe DAF i nil) treats sleep disorders, such as narcolepsy, obstructive sleep apnea, and shift work disorder. It works by promoting wakefulness. It belongs to a group of medications called stimulants.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Nuvigil

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Depression
• Heart disease
• High blood pressure
• Kidney disease
• Liver disease
• Schizophrenia
• Substance use disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to armodafinil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Keep taking this medication unless your care team tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 17 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Amphetamine or dextroamphetamine
• Dexmethylphenidate or methylphenidate
• MAOIs, such as Marplan, Nardil, and Parnate
• Pemoline
• Procarbazine

This medication may also interact with the following:

• Antifungal medications, such as itraconazole or ketoconazole
• Barbiturates, such as phenobarbital
• Carbamazepine
• Cyclosporine
• Diazepam
• Estrogen or progestin hormones
• Medications for mental health conditions
• Phenytoin
• Propranolol
• Triazolam
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

This medication may affect your coordination, reaction time, or judgment. It may also hide signs that you are tired. This medication will not eliminate your abnormal tendency to fall asleep and is not a replacement for sleep. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Estrogen or progestin hormones may not work as well while you are taking this medication and for 1 month after stopping treatment. If you are using these hormones for contraception, talk to your care team about using a second type of contraception. A barrier contraceptive, such as a condom or diaphragm, is recommended.

It is unknown if the effects of this medication will be increased by the use of caffeine. Caffeine is found in many foods, beverages, and medications. Ask your care team if you should limit or change your intake of caffeine-containing products while on this medication.

Do not stop previously prescribed treatments for your condition, such as a CPAP machine, except on the advice of your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Increase in blood pressure
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Headache
• Nausea
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.