Nuvigil

Nuvigil is a prescription medication used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

• narcolepsy
• obstructive sleep apnea (OSA). Nuvigil is used with other medical treatments for this sleep disorder. Nuvigil does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition. It is important that you continue to use these treatments as prescribed by your doctor.
• shift work disorder (SWD)

Nuvigil is in a class of medications called wakefulness-promoting agents. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.

This medication comes in tablet form to take by mouth. It is usually taken once a day and is taken with or without food.

Your doctor will tell you the right time of day to take Nuvigil.

Common side effects of Nuvigil include headache, nausea, dizziness, and trouble sleeping.

Nuvigil is a prescription medication used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

• narcolepsy
• obstructive sleep apnea (OSA). Nuvigil is used with other medical treatments for this sleep disorder. Nuvigil does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition. It is important that you continue to use these treatments as prescribed by your doctor.
• shift work disorder (SWD)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cephalon, Inc.

Serious side effects have been reported with Nuvigil. See the “Nuvigil Precautions” section.

Common side effects of Nuvigil include the following:

• headache
• nausea
• dizziness
• trouble sleeping

This is not a complete list of Nuvigil side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• medications that block a protein in the body (CYPA4) such as antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), and some macrolide antibiotics (clarithromycin, telithromycin, erythromycin)
• medications that use the enzyme CYP3A4 such as cyclosporine (Neoral, Gengraf, Sandimmune), midazolam (Versed), and triazolam (Halcion)
• medications that use the enzyme CYP2C19 such as omeprazole (Prilosec), diazepam (Valium), phenytoin (Dilantin), and propranolol (Inderal)
• hormonal birth control method, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs)

Tell your doctor if you take warfarin (Coumadin, Jantoven). Caution may need to be taken.

Tell your doctor if you take monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect). The data is not available, but caution is advised.

This is not a complete list of Nuvigil drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nuvigil including the following:

• Serious rash or serious allergic reaction. Nuvigil may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening. Stop taking Nuvigil and call your doctor right away or get emergency help if you have any of these symptoms:
  • skin rash, hives, sores in your mouth, or your skin blisters and peels
  • swelling of your face, eyes, lips, tongue, or throat
  • trouble swallowing or breathing
  • fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine

If you have a severe rash with Nuvigil, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.

• Mental (psychiatric) symptoms. Tell your doctor if you notice any of the following symptoms:
  • depression
  • feeling anxious
  • hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
  • an extreme increase in activity and talking (mania)
  • thoughts of suicide
  • aggressive behavior
  • other mental problems
• Symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing. Tell your doctor if you notice any of these symptoms.

Do not drive a car or do other dangerous activities until you know how Nuvigil affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.

You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking Nuvigil.

Nuvigil is classified as federally controlled substance (C-IV), because it can be abused or lead to dependence. Keep Nuvigil in a safe place to prevent misuse and abuse. Selling or giving away Nuvigil may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Do not take Nuvigil if you:

• are allergic to Nuvigil or to any of its ingredients
• have had a rash or allergic reaction to either Nuvigil or Provigil (modafinil). These medicines are very similar.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nuvigil, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Nuvigil, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Nuvigil or to any of its ingredients
• have a history of mental health problems, including psychosis
• have heart problems or had a heart attack
• have high blood pressure. Your blood pressure may need to be checked more often while taking Nuvigil.
• have liver or kidney problems
• have a history of drug or alcohol abuse or addiction
• if you are having surgery, including dental surgery
• are pregnant or planning to become pregnant. It is not known if Nuvigil will harm your unborn baby.
• are breastfeeding. It is not known if Nuvigil passes into your milk. Talk to your doctor about the best way to feed your baby if you take Nuvigil.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nuvigil falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Hormonal birth control methods may not work while you take Nuvigil. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking Nuvigil, and for one month after stopping Nuvigil. Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Nuvigil crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Nuvigil.

Take Nuvigil exactly as prescribed.

Nuvigil comes in tablet form and can be taken with or without food.

Your doctor will tell you the right time of day to take Nuvigil.

• People with narcolepsy or obstructive sleep apnea (OSA) usually take Nuvigil one time each day in the morning.
• People with shift work disorder (SWD) usually take Nuvigil about 1 hour before their work shift.

Do not change the time of day you take Nuvigil unless you have talked to your doctor. If you take Nuvigil too close to your bedtime, you may find it harder to go to sleep.

Talk to your doctor if your work shift does not begin at the same time every day.

If you take more than your prescribed dose or if you take an overdose of Nuvigil, call your doctor or poison control center right away.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Nuvigil at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function
• your age

The recommended dose of Nuvigil (armodafinil) for patients with obstructive sleep apnea (OSA) or narcolepsy is 150 mg or 250 mg given as a single dose in the morning. In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated.

The recommended dose of Nuvigil (armodafinil) for patients with shift work disorder (SWD) is 150 mg given daily approximately 1 hour prior to the start of their work shift.

If you take too much Nuvigil, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Nuvigil at 20° to 25°C (68° to 77°F).
• Keep this and all medicines out of the reach of children.
• Nuvigil is classified as federally controlled substance (C-IV), because it can be abused or lead to dependence. Keep Nuvigil in a safe place to prevent misuse and abuse.