Provigil, a central nervous system (CNS) stimulant, is believed to work by increasing the availability of certain chemicals in the brain, most notably dopamine. Provigil is available in tablet form.
Provigil is classified as a Schedule IV controlled substance. This means it has a potential for abuse and dependence but is less likely to cause dependence than stimulants like Adderall (a Schedule II controlled substance).
What Is Provigil Used For?
The Food and Drug Administration (FDA) has approved Provigil to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder.
Brand Name(s): Provigil
Administration Route(s): Oral
Drug Availability: Prescription
Therapeutic Classification: CNS stimulant
Available Generically: Yes
Controlled Substance: Potential for abuse
Active Ingredient: Modafinil
Dosage Form(s): Tablet
Provigil does not cure these conditions and will only work for as long as you take it.
How to Take Provigil
Take Provigil by mouth exactly as instructed by your healthcare provider. You can take it with or without food, depending on your personal preference. You should not change your dose or take it at a different time of day without speaking to your provider first.
Avoid drinking alcohol, driving, and engaging in any potentially dangerous activities while taking Provigil.
Contact your healthcare team if you ever have any questions about taking your medication or if you feel Provigil isn’t helping you.
Storage
Store your Provigil at room temperature, and ensure that the pill bottle is out of reach of children and pets.
Off-Label Uses
Provigil is used off-label to treat fatigue or sleepiness associated with the following conditions:
Multiple sclerosis Parkinson’s disease Cancer Depression
Off-label use means that even if a drug is not FDA approved to treat a particular condition, a healthcare provider can still prescribe it if they judge it to be medically appropriate.
What Are the Side Effects of Provigil?
This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Like other medications, Provigil can cause side effects. Tell your healthcare provider about any side effects you experience while using Provigil, especially if they persist or worsen.
Common Side Effects
The most common side effects of taking Provigil include:
Headache Back pain Nausea Feeling nervous or anxious Stuffy nose Diarrhea Trouble sleeping Dizziness Indigestion
Severe Side Effects
Potential severe side effects of Provigil include:
Symptoms or signs of an allergic reaction: Hives, peeling skin, blisters, mouth sores, swelling of the face, eyes, lip, or tongue Mental symptoms: Depression, anxiety, seeing or hearing things that aren’t there (hallucination), extreme increase in activity or talking (mania) Symptoms of a heart problem: Chest pain or irregular heartbeat
Call your healthcare provider right away if you have severe side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
Dosage: How Much Provigil Should I Take?
Modifications
There are no specific Provigil dosing adjustments for adults with kidney disease or mild to moderate liver impairment. For adults with severe liver impairment, the manufacturer recommends reducing the Provigil dose to one-half of that recommended for patients with normal liver function.
If you experience a serious side effect, you or your provider may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
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 or obstructive sleep apnea/hypopnea syndrome: Adults and teenagers 17 years of age and older—200 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor. For shift work sleep disorder: Adults and teenagers 17 years of age and older—200 milligrams (mg) one hour before you begin working. Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
There are no specific Provigil dosing adjustments for older adults (aged 65 years or older). Yet, since Provigil may be processed more slowly in older individuals, healthcare providers often start at a lower dose and monitor more closely for side effects.
Be sure to tell your provider if you are pregnant or planning to become pregnant. Animal studies suggest that Provigil may cause harm to the baby. Also, limited data from a pregnancy registry found an increased risk of major birth defects following modafinil exposure to the baby in the mother’s womb.
It’s not known if Provigil passes into breast milk, but you should discuss whether you are breastfeeding or plan on breastfeeding with your provider.
Missed Dose
If you miss a dose of your Provigil, take the dose as soon as you remember, unless it’s later in the day. In that case, skip the dose and go back to your usual dosing schedule. Taking Provigil too late in the day might cause problems sleeping that night. Do not ever double-up on doses.
If you find that you are missing Provigil doses often, consider setting an alarm on your phone, purchasing a pillbox, or asking a loved one or friend to remind you when to take your dose.
Overdose: What Happens If I Take Too Much Provigil?
Taking more than the maximum recommended dose of Provigil can cause unpleasant side effects. There is no specific antidote to treat a Provigil overdose. Supportive care, including heart monitoring, may be warranted in some cases.
Symptoms of a Provigil overdose can include:
Trouble sleepingRestlessnessFeeling disoriented, confused, excited, or agitatedHallucinationsNausea and diarrheaFast or slow heart rateChest painIncrease in blood pressure
Precautions
What Are Reasons I Shouldn’t Take Provigil?
You should not take Provigil if you have a known allergy or sensitivity to Provigil or any of its ingredients.
If someone collapses or isn’t breathing after taking Provigil, call 911 immediately.
It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.
Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
This medicine may cause you to have a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a skin rash; itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may cause serious allergic reactions affecting multiple body organs (e.g., heart, liver, or blood cells). Stop using this medicine and check with your doctor right away if you have the following symptoms: chest pain or discomfort, fever and chills, dark urine, headache, rash, stomach pain, unusual tiredness, unusual bleeding or bruising, or yellow eyes or skin.
If you think modafinil is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.
If you are using a medicine for birth control (such as birth control pills, implants, shots, patches, vaginal rings, or an IUD), it may not work properly while you are taking modafinil. To keep from getting pregnant, use another form of birth control while you are using this medicine and for one month after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
Modafinil may cause some people to feel dizzy, drowsy, have trouble thinking or controlling movements, or trouble seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.
Stop using this medicine and check with your doctor right away if you have the following symptoms while taking the medicine: aggressive behavior, anxiety, depression, hallucinations, mania, thoughts of suicide, or other mental problems.
If you have been taking this medicine for a long time or in large doses and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on modafinil are:
a strong desire or need to continue taking the medicine. a need to increase the dose to receive the effects of the medicine. withdrawal side effects when you stop taking the medicine.
While you are taking this medicine, be careful to limit the amount of alcohol that you drink.
If you have been taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.
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.
Let your healthcare provider know if you have a history of high blood pressure or mental health, heart, or liver problems. Your healthcare provider may need to monitor these underlying conditions while you are taking Provigil.
Moreover, Provigil is not approved to treat children for any health condition. Studies of children taking Provigil showed serious side effects, including severe skin rashes and psychiatric or nervous system reactions.
Lastly, Provigil is a controlled substance and may be habit forming or lead to dependence. As a result, Provigil should be used cautiously in people who have a history of substance abuse disorder.
What Other Medications May Interact With Provigil?
Several medications may interact with Provigil, including:
Hormonal birth control methods: Hormonal birth control (e. g. , pills, shots, implants, patches, rings, and intrauterine devices) may not work as well when used at the same time as Provigil and for one month after stopping Provigil. Gengraf (cyclosporine): Blood levels of Gengraf can increase while taking Provigil. Cytochrome P450 2C19 (CYP2C19) substrates: When taken together, Provigil can increase exposure to medications that are CYP2C19 substrates, such as Prilosec (omeprazole), Dilantin (phenytoin), and Valium (diazepam).
If you are taking a medicine that interacts with Provigil, your healthcare provider may need to change your dose, choose an alternative medicine, and/or monitor certain drug levels.
What Medications Are Similar?
A similar medication called Nuvigil (armodafinil) is available to use for improving wakefulness in patients with narcolepsy, obstructive sleep apnea, and shift-work disorder.
Provigil and Nuvigil share a similar chemical structure, availability, dosing (once a day), drug interactions, and side effects. However, blood levels of Nuvigil are higher later in the day compared with Provigil, suggesting that Nuvigil may be better at improving wakefulness over the course of a day.
Provigil and Nuvigil both have stimulant-like effects, similar to drugs like Adderall (dextroamphetamine-amphetamine) and Ritalin (methylphenidate).
That said, the potential for abuse and dependence is higher for stimulant drugs than for Provigil or Nuvigil. Also, Adderall and Ritalin are approved to treat attention deficit/hyperactivity disorder (ADHD), while Provigil and Nuvigil are not.
How Can I Stay Healthy While Taking Provigil?
Provigil will not cure your health condition, but it can ease the excessive sleepiness you feel during the day.
Provigil is also sometimes used off-label to treat fatigue associated with multiple sclerosis, cancer, Parkinson’s disease, and depression.
Headache Nervousness and anxietyRunny noseNausea, diarrhea, and indigestionBack painTrouble sleepingDizziness
Serious side effects of Provigil are not common but require immediate medical attention and include:
Allergic reactionsPsychiatric symptomsHeart problems
Provigil is classified as a Schedule IV controlled substance. This means it’s less likely to cause dependence than stimulants like Adderall (a Schedule II controlled substance).
Taking Provigil will hopefully grant you the time and energy you need to focus on other healthy behaviors in your life, such as engaging in physical activity or connecting with friends or family members.
Keep taking or using your other health-related medications or devices. For instance, do not stop using your CPAP machine for sleep apnea unless your healthcare provider tells you to do so.
Also, always tell your healthcare provider if you are taking any new medications or experiencing any bothersome or persistent side effects. Remember that Provigil can be habit forming, so let your healthcare team know if you think this is becoming a problem for you.
In the end, Provigil can be a welcome relief to your daily exhaustion, but it’s not a perfect or miracle drug. Scientists are still learning about how it works and its long-term effects. As with any medication, be mindful while taking Provigil and stay in touch with your healthcare team.
