Description
Armodafinil is used to help people who have narcolepsy, obstructive sleep apnea (also called hypopnea syndrome), or shift work sleep disorders to stay awake during the day. This medicine does not cure these conditions and will only work as long as you continue to take it.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of armodafinil in the pediatric population. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of armodafinil have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of armodafinil in the elderly. However, elderly patients are more likely to have liver problems, which may require an adjustment in the dose for patients receiving armodafinil.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Amiodarone
- Amphetamine
- Atogepant
- Belzutifan
- Benzhydrocodone
- Buprenorphine
- Cariprazine
- Citalopram
- Codeine
- Desogestrel
- Dextroamphetamine
- Dienogest
- Dihydrocodeine
- Diltiazem
- Drospirenone
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Fentanyl
- Fexinidazole
- Gestodene
- Hydrocodone
- Insulin Aspart, Recombinant
- Iobenguane I 131
- Landiolol
- Levonorgestrel
- Lisdexamfetamine
- Lumateperone
- Macimorelin
- Mavacamten
- Medroxyprogesterone
- Meperidine
- Mestranol
- Methadone
- Nifedipine
- Nomegestrol
- Norelgestromin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clopidogrel
- Midazolam
- Omeprazole
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Angina (severe chest pain), unstable or
- Drug abuse or dependence, history of or
- Heart attack, recent—Use with caution. May cause side effects to become worse.
- Depression, history of or
- Hypertension (high blood pressure) or
- Mania, history of or
- Psychosis (mental illness), history of—Use with caution. May make these conditions worse.
- Left ventricular hypertrophy (heart disease), history of or
- Mitral valve prolapse (heart disease)—Should not be used in patients with these conditions.
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you have sleep apnea and use a continuous positive airway pressure (CPAP) machine at night, continue using this machine with the medicine.
Take this medicine at the same time each day. Do not change your schedule without talking to your doctor.
You may take this medicine with or without food.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For narcolepsy and obstructive sleep apnea:
- Adults—150 to 250 milligrams (mg) once a day in the morning.
- Children—Use and dose must be determined by your doctor.
- For shift work sleep disorder:
- Adults—150 milligrams (mg) 1 hour before you begin working.
- Children—Use and dose must be determined by your doctor.
- For narcolepsy and obstructive sleep apnea:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
This medicine does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy, sleep apnea, or a shift work sleep problem. Ask your doctor for advice about good sleep habits.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may cause serious allergic reactions that may involve multiple organs, such as your liver or kidneys. Check with your doctor right away if you have a fever, dark urine, headache, rash, stomach pain, swollen, painful, or tender lymph glands in neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.
Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
Hormonal birth control pills, implants, patches, shots, vaginal rings, or IUDs may not work as well while you are using armodafinil. To keep from getting pregnant, use a second form of birth control together with your pills, implant, patch, shot, vaginal ring, or IUD while you are using this medicine. Continue using the second form of birth control for 1 month after your last dose. Other forms of birth control include condoms, a diaphragm, or contraceptive foam or jelly.
Armodafinil may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.
Check with your doctor if you have been taking this medicine for a long time and feel that it is not working as well as before. Do not increase your dose without talking to your doctor. Some people can become mentally or physically dependent on this medicine. If you have questions, talk with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Blistering, burning, crusting, dryness, or flaking of the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficult or labored breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- frequent urination
- headache, severe and throbbing
- increased volume of pale, dilute urine
- itching, scaling, severe redness, soreness, or swelling of the skin
- rash
- shakiness in the legs, arms, hands, or feet
- tightness in the chest
- trembling or shaking of the hands or feet
- trouble breathing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Anxiety
- blurred vision
- chest pain or discomfort
- confusion about identity, place, and time
- diarrhea
- dry mouth
- headache
- hyperventilation
- irritability
- lightheadedness, dizziness, or fainting
- nausea
- pounding in the ears
- restlessness
- seeing, hearing, or feeling things that are not there
- slow heartbeat
- trouble sleeping
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Acid or sour stomach
- belching
- chills
- cough
- difficulty having a bowel movement (stool)
- discouragement
- feeling sad or empty
- general feeling of discomfort or illness
- heartburn
- indigestion
- joint pain
- loss of appetite
- loss of interest or pleasure
- mood or mental changes
- muscle aches and pains
- runny nose
- shivering
- sore throat
- stomach discomfort, upset, or pain
- sweating
- thirst
- tiredness
- trouble concentrating
- vomiting
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20071125
