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Description

Generic Name

Modafinil

Active Ingredient

Modafinil

Chemical Name and Composition

Modafinil is chemically described as 2-[(diphenylmethyl)sulfinyl]acetamide.

Modafinil is a white to off-white crystalline powder. It is practically insoluble in water and slightly soluble in methanol and acetone. It has a molecular weight of about 273.35. Modafinil is a racemic compound, meaning it contains two mirror-image forms of the molecule.

Medication Classification

Provigil is a wakefulness-promoting agent (a wakefulness-promoting medication). Its exact mechanism is not fully understood. It promotes wakefulness through effects on certain areas of the brain involved in the sleep-wake cycle, and it acts differently from typical stimulants such as amphetamines.

Provigil is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indications

Provigil is indicated to improve wakefulness in adults with excessive sleepiness associated with:

• Narcolepsy
• Obstructive sleep apnea (OSA): Used alongside standard treatment for the underlying airway obstruction, such as continuous positive airway pressure (CPAP). Provigil does not treat the airway obstruction itself.
• Shift work sleep disorder (SWSD): For excessive sleepiness in people whose work schedule disrupts normal sleep.

Provigil is used to treat the excessive sleepiness caused by these conditions. It does not cure the underlying condition or take the place of getting enough sleep.

Dosage Forms and Available Strengths

• Dosage Form: Oral tablets
• Route of Administration: Oral
• Available Strengths: 100 mg and 200 mg

Inactive Ingredients

Inactive ingredients may include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Provigil exactly as prescribed by your healthcare provider. Your provider will set your dose based on your condition and your response. Do not change your dose or stop taking it without medical guidance.

How to Take Provigil

• Swallow the tablet with water.
• Take Provigil once a day, at the same time each day, unless your provider tells you otherwise.
• For narcolepsy and obstructive sleep apnea, the usual dose is taken in the morning.
• For shift work sleep disorder, the dose is usually taken about 1 hour before the start of your work shift.
• Do not take more than prescribed, and do not take it more often than directed.

Food Considerations

Provigil may be taken with or without food. Taking it with food may delay how quickly it starts to work but does not change the total amount absorbed. Avoid alcohol while taking Provigil, as the combination can affect how you feel and think.

Missed Dose Instructions

• If you miss your morning dose, avoid taking it late in the day, as it may make it hard to fall asleep at night.
• If it is already afternoon or evening, skip the missed dose and take your next dose at the usual time.
• Do not take two doses at once to make up for a missed dose.
• If you are unsure what to do, contact your healthcare provider or pharmacist.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children.

Disposal

Because Provigil is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal. Ask your pharmacist if you have questions about disposal.

Special Instructions

Children: The safety and effectiveness of Provigil have not been established in pediatric patients. It is not approved for use in children. Serious skin reactions, including some requiring hospitalization, have been reported in children who used modafinil. Keep the medication out of the reach of children. If a child swallows this medication, seek emergency care immediately.

Elderly Patients: Older patients may clear modafinil from the body more slowly. A provider may start at a lower dose and monitor closely.

Patients with Liver Problems: Use with caution. A lower dose is often recommended for patients with severe liver problems, since impaired liver function can increase drug levels.

Caregivers: Give the medication exactly as prescribed. Watch for skin rash, blistering, swelling of the face or throat, new or worsening mood or behavior changes, chest pain, or trouble breathing, and seek care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Provigil can usually be stopped without a gradual taper, but talk to your provider before stopping.
• Watch for a return of excessive sleepiness after stopping, which can affect activities such as driving.
• Some people may notice tiredness or low mood after stopping regular use. Tell your provider if this happens.

Overdose Warning

An overdose of Provigil can be serious. Symptoms of overdose may include:

• Trouble sleeping (insomnia)
• Restlessness, agitation, or confusion
• Nervousness or tremor
• A fast, pounding, or irregular heartbeat
• High or, in some cases, low blood pressure
• Nausea or diarrhea
• Chest pain

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Provigil and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Serious skin reactions: A severe rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Warning signs may include skin blistering or peeling, mouth sores, hives, or a rash with fever. These reactions can be life-threatening.
• Angioedema and serious allergic reactions: Swelling of the face, eyes, lips, tongue, or throat; trouble breathing or swallowing; or hives.
• Multi-organ hypersensitivity reactions: Fever, rash, swollen lymph nodes, or signs of problems in organs such as the liver, heart, or blood.
• Psychiatric symptoms: New or worsening anxiety, agitation, depression, hallucinations, mania, unusual thoughts or behavior, aggression, or thoughts of harming yourself.
• Cardiovascular events: Chest pain, a fast or pounding heartbeat, or shortness of breath. Report these promptly, especially if you have a history of heart problems.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Headache
• Nausea
• Nervousness
• Trouble sleeping (insomnia)
• Dizziness
• Anxiety
• Dry mouth
• Diarrhea
• Reduced appetite

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

Conditions to Disclose to Your Healthcare Provider

Before taking Provigil, tell your healthcare provider if you have or have had any of the following:

• Heart problems, including a heart attack, chest pain, an irregular heartbeat, or high blood pressure
• Mitral valve prolapse or a history of an abnormal heart response to stimulant medicines
• Mental health conditions, including depression, anxiety, mania, psychosis, or thoughts of suicide
• Liver or kidney problems
• A previous skin rash or allergic reaction to modafinil or armodafinil
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed
• Use of any hormonal birth control, such as pills, implants, patches, injections, or an intrauterine device (IUD)

Contraindications

Do not take Provigil if you:

• Have a known hypersensitivity to modafinil or armodafinil, or to any component of the formulation. Serious reactions, including skin rash and angioedema, have occurred.

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Modafinil can affect several liver enzymes, which changes how other drugs work. Key interactions include:

• Hormonal contraceptives: Modafinil can reduce the effectiveness of birth control pills, implants, patches, injections, and IUDs. This can lead to unintended pregnancy. Use an additional or alternative non-hormonal method of birth control during treatment and for one month after stopping Provigil.
• CYP3A4 substrates: Modafinil induces the CYP3A4 enzyme and may lower the levels and effects of drugs processed by it, such as certain hormonal contraceptives, cyclosporine, and some other medicines.
• CYP2C19 substrates: Modafinil may inhibit CYP2C19, which can raise the levels of drugs such as certain antidepressants, diazepam, phenytoin, and some proton pump inhibitors. Dose adjustments may be needed.
• CYP3A4 inhibitors and inducers: Drugs such as certain antifungals, macrolide antibiotics, rifampin, or carbamazepine may change modafinil levels.
• Warfarin: Your provider may monitor your blood clotting more closely, as modafinil can affect warfarin levels.
• CNS stimulants: Combining modafinil with other stimulants may increase the risk of high blood pressure, fast heart rate, nervousness, and trouble sleeping.
• Monoamine oxidase inhibitors (MAOIs): Use caution when combining modafinil with an MAOI, as their combined effects have not been fully studied. Talk to your provider before using these together.

Monitoring Requirements

Your healthcare provider may monitor:

• Your response to treatment and level of daytime sleepiness
• Blood pressure and heart rate, especially in patients with heart conditions
• Signs of skin reactions or allergic reactions, particularly early in treatment
• New or worsening mood, behavior, or mental health changes
• The effectiveness of hormonal birth control and the need for additional contraception
• Signs of tolerance, dependence, or misuse

Abuse, Dependence, and Misuse Warnings

Provigil is a Schedule IV controlled substance.

• Modafinil produces psychoactive and euphoric effects in some people and may be a target for misuse.
• Physical and psychological dependence can occur, though the risk is generally considered lower than with typical stimulants.
• Do not increase your dose on your own.
• Do not sell or give away Provigil. Doing so may harm others and is against the law.
• Use with caution if you have a history of substance abuse, and tell your provider about any such history.

Long-Term Use Considerations

• If long-term treatment is needed, your provider should regularly reassess whether it is still appropriate.
• Provigil treats excessive sleepiness but does not cure the underlying sleep disorder. Continue any recommended treatment for your condition, such as CPAP for obstructive sleep apnea.
• Provigil is not a replacement for healthy sleep habits or getting enough sleep.
• Tell your provider if your sleepiness returns or worsens during treatment.

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Patient Counseling Information

Safe Medication Use

• Take Provigil exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Take your dose in the morning for narcolepsy or obstructive sleep apnea, or about 1 hour before your shift for shift work sleep disorder, unless your provider directs otherwise.
• Avoid taking Provigil late in the day, as it may make it hard to fall asleep.
• If you have obstructive sleep apnea, keep using your prescribed treatment, such as CPAP. Provigil does not treat the airway problem itself.
• Do not share Provigil with anyone else. Sharing is dangerous and against the law.
• Keep it in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Serious skin and allergic reactions: Stop taking Provigil and get medical help right away if you develop a rash, blistering, mouth sores, swelling of the face or throat, or trouble breathing.
• Birth control: Provigil can make hormonal birth control less effective, raising the risk of unintended pregnancy. Use an additional or alternative non-hormonal method of birth control while taking Provigil and for one month after stopping it.
• Mental health: Tell your provider about any new or worsening mood, thinking, or behavior changes, including anxiety, agitation, or thoughts of self-harm.
• Driving and machinery: Provigil may improve wakefulness, but your sleepiness may not fully go away. Do not drive or do activities that require full alertness until you know how the medication affects you and your condition is well controlled.
• Alcohol: Avoid alcohol while taking Provigil.
• Pregnancy: Tell your provider if you are pregnant or plan to become pregnant, so treatment can be managed safely.
• Breastfeeding: Talk to your provider before breastfeeding while taking Provigil.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Develop a skin rash, blistering or peeling skin, mouth sores, or hives
• Have swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing
• Develop fever, swollen lymph nodes, or signs of organ problems
• Have new or worsening anxiety, agitation, depression, hallucinations, or thoughts of harming yourself
• Have chest pain, a fast or pounding heartbeat, or shortness of breath
• Find that your sleepiness returns or does not improve
• Have any symptom that concerns you or does not go away