Modafinil

Modafinil is a prescription drug that promotes wakefulness and can be used to treat conditions such as obstructive sleep apnea, hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder.

Modafinil is available under the following different brand names: Provigil.

Adult and pediatric dosages:

Tablet, Schedule IV

• 100 mg
• 200 mg

Dosage Considerations – Should be Given as Follows:

Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

Adults:

• 200 mg orally each morning, no more than 400 mg per day

Pediatric

• Children under 16 years old: not recommended
• Children 16 years and older: 200 mg orally each morning, no more than 400 mg per day

Narcolepsy

Adults:

• 200 mg orally each morning, no more than 400 mg per day

Pediatric:

• Children under 16 years old: not recommended
• Children 16 years and older: 200 mg orally each morning, not to exceed 400 mg per day

Shift Work Sleep Disorder

Adults:

• 200 mg orally 1 hour prior to patient's work shift

Pediatric:

• Children under 16 years old: not recommended
• 200 mg orally 1 hour prior to patient's work shift

Dosage Modifications

• Hepatic impairment, severe: 100 mg orally each morning

Other indications and uses

• Off-label: may reduce fatigue in multiple sclerosis (MS) patients and depression.

Side effects associated with use of Modafinil, include the following:

• headaches
• runny or stuffy nose
• decreased appetite
• abdominal pain
• nervousness
• fainting
• irregular heartbeat (arrhythmia)
• low blood pressure (hypotension)
• high blood pressure (hypertension)
• T-wave changes
• amnesia
• anxiety
• sudden muscle weakness or paralysis
• chills
• depression
• dizziness
• epistaxis
• fever
• difficulty sleeping (insomnia)
• numbness and tingling
• tremor
• drug hypersensitivity syndrome
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• loss of appetite
• diarrhea
• dry mouth
• mouth ulcer
• vomiting with a sever blistering, peeling, and red skin rash
• abnormal liver function tests
• chest pain
• neck pain
• shortness of breath
• sore throat
• bruising
• severe tingling, numbness and pain
• muscle weakness
• easy bruising or bleeding
• white patches or sores inside your mouth or lips
• hallucinations, unusual thoughts or behavior

Rare side effects of Modafinil include:

• reversible psychosis

Post marketing side effects of Modafinil reported include:

• aggression
• psychomotor hyperactivity

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe Interactions of Modafinil include:
  • cobimetinib
  • isocarboxazid
  • linezolid
  • ombitasvir/paritaprevir/ritonavir
  • phenelzine
  • selegiline transdermal
  • tranylcypromine
• Modafinil has serious interactions with at least 35 different drugs.
• Modafinil has moderate interactions with at least 35 different drugs.
• Modafinil has mild interactions with at least 81 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

• May impair ability to operate heavy machinery and perform hazardous tasks
• This medication contains modafinil. Do not take Provigil if you are allergic to modafinil or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Possible hypersensitivity

Effects of Drug Abuse

• No information provided

Short-Term Effects

• Risk of skin reactions, discontinue if rash or other hypersensitivity reactions occur. May impair ability to operate heavy machinery and perform hazardous tasks
• See "What Are Side Effects Associated with Using Modafinil?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Modafinil?"

Cautions

• Risk of skin reactions, Steven-Johnsons Syndrome, toxic necrolysis, and drug rash with eosinophilia and systemic symptoms; discontinue if rash or other hypersensitivity reactions occur
• May impair ability to operate heavy machinery and perform hazardous tasks
• Not recommended in patients with angina, cardiac ischemia, and recent history of myocardial infarction, left ventricular hypertrophy or mitral valve prolapse
• Use with caution in severe hepatic impairment, elderly, and patients with a history of depression or psychosis (modafinil may exacerbate psychiatric symptoms) or mania
• Consider dose adjustment of CYP3A4/5 substrate medications
• Use with caution in patients with Tourette's syndrome as stimulants may unmask ticks
• May reduce effectiveness of steroidal contraceptives one month after discontinuation of drug therapy
• Reassess degree of sleepiness frequently, if used together with continuous positive airway pressure (CPAP), periodic assessment of CPAP compliance is necessary
• Discontinue at first sign of serious rash, symptoms of angioedema or anaphylaxis, and if multiorgan hypersensitivity reaction is suspected

Pregnancy and Lactation

• Use modafinil during pregnancy with caution if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• Transfer of modafinil into breast milk is unknown, therefore use with caution if breastfeeding.