Generic Name: modafinil
Brand Name: Provigil

Drug Description

What is Provigil and how is it used?

Provigil 200mg is a prescription medicine used to treat the symptoms of excessive sleepiness caused by obstructive sleep apnea, narcolepsy and shift work sleep disorder. Provigil may be used alone or with other medications.

Provigil belongs to a class of drugs called Stimulants, CYP3AF Inducers, Moderate.

It is not known if Provigil is safe and effective in children.

What are the possible side effects of Provigil 200mg?

Provigil may cause serious side effects including:

Skin rash (no matter how small)
Mouth sores
Trouble swallowing
Fever
Swelling in your legs
Dark urine
Yellowing of the skin or eyes (jaundice)
Swelling in your face, eyes, lips, tongue
Depression
Anxiety
Suicidal thoughts or actions
Unusual thoughts or behavior
Aggression
Being more active or talkative than usual
Chest pain
Trouble breathing
Uneven heartbeats
Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Provigil 200mg include:

Headache
Dizziness
Feeling nervous
Anxiety
Back pain
Nausea
Diarrhea
Upset stomach
Sleep problems
Stuffy nose

Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Provigil. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

DESCRIPTION
Provigil 200mg (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

The chemical structure is:

Provigil 200mg Structural Formula Illustration
Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone.

Provigil 200mg tablets following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

INDICATIONS
Provigil 200mg is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

Limitations of Use
In OSA, Provigil 200mg is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with this medication for excessive sleepiness.

DOSAGE AND ADMINISTRATION

Dosage In Narcolepsy And Obstructive Sleep Apnea (OSA)
The recommended dosage of Provigil 200mg for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.

Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose.

Dosage In Shift Work Disorder (SWD)
The recommended dosage of Provigil for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.

Dosage Modifications In Patients With Severe Hepatic Impairment
In patients with severe hepatic impairment, the dosage of PROVIGIL should be reduced to one-half of that recommended for patients with normal hepatic function.

Use In Geriatric Patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations].

Dosage Forms And Strengths

100 mg – capsule-shaped, white to off white, tablet, debossed with “PROVIGIL” on one side and “100 MG” on the other.
200 mg – capsule-shaped, white to off white, scored tablet, debossed with “PROVIGIL” on one side and “200 MG” on the other.

Provigil 200mg (modafinil) tablets are available as follows:

100 mg: Each capsule-shaped, white to off white tablet is debossed with “PROVIGIL” on one side and “100 MG” on the other.

200 mg: Each capsule-shaped, white to off white, scored tablet is debossed with “PROVIGIL” on one side and “200 MG” on the other.

SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:

Serious Rash, including Stevens-Johnson Syndrome
Angioedema and Anaphylaxis Reactions
Multi-organ Hypersensitivity Reactions
Persistent Sleepiness
Psychiatric Symptoms
Effects on Ability to Drive and Use Machinery
Cardiovascular Events

Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Provigil 200mg has been evaluated for safety in over 3,500 patients, of whom more than 2,000 patients with excessive sleepiness are associated with OSA, SWD, and narcolepsy.

WARNINGS

Serious Rash, including Stevens-Johnson Syndrome
Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil.

Provigil 200mg is not approved for use in pediatric patients for any indication.

In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients (age < 17 years); these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia).

The median time to rash that resulted in discontinuation was 13 days. No such cases were observed among 380 pediatric patients who received placebo. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil.

There are no factors that are known to predict the risk of occurrence or the severity of rash associated with modafinil. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 3 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash.

Although benign rashes also occur with modafinil, it is not possible to reliably predict which rashes will prove to be serious. Accordingly, modafinil should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.

OVERDOSE
In clinical trials, a total of 151 protocol-specified doses ranging from 1000 to 1600 mg/day (5 to 8 times the recommended daily dose of Provigil 200mg) have been administered to 32 subjects, including 13 subjects who received doses of 1000 or 1200 mg/day for 7 to 21 consecutive days. In addition, several intentional acute overdoses occurred; the two largest being 4500 mg and 4000 mg taken by two subjects participating in foreign depression studies. None of these study subjects experienced any unexpected or life-threatening effects.

Adverse reactions that were reported at these doses included excitation or agitation, insomnia, and slight or moderate elevations in hemodynamic parameters. Other observed high-dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea, and decreased prothrombin time.

Symptoms most often accompanying Provigil 200mg overdose, alone or in combination with other drugs have included insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, agitation, anxiety, excitation, and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.

Cases of accidental ingestion/overdose have been reported in children as young as 11 months of age. The highest reported accidental ingestion on a mg/kg basis occurred in a three-year-old boy who ingested 800-1000 mg (50-63 mg/kg) of PROVIGIL. The child remained stable. The symptoms associated with overdose in children were similar to those observed in adults.