Modafinil
Generic Name: modafinil
Brand Names:
Modafinil
11 DESCRIPTION Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35. The chemical structure is: Modafinil, USP 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.
Overview
11 DESCRIPTION Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35. The chemical structure is: Modafinil, USP 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.
Uses
1 INDICATIONS AND USAGE Modafinil tablets are 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, modafinil tablets are 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 modafinil tablets for excessive sleepiness.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage of modafinil tablets for each indication is as follows: Narcolepsy or OSA: 200 mg once a day in the morning. ( 2.1 ) SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift. ( 2.2 ) Severe Hepatic Impairment: reduce dose to half the recommended dose. ( 2.3 , 12.3 ) Geriatric Patients: consider lower dose. ( 2.4 , 12.3 ) 2.1 Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA) The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Serious Rash, including Stevens-Johnson Syndrome [see Warnings and Precautions ( 5.1 )] Angioedema and Anaphylaxis Reactions [see Warnings and Precautions ( 5.2 )] Multi-organ Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Persistent Sleepiness [see Warnings and Precautions ( 5.4 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.5 )] Effects on Ability to Drive and Use Machinery [see Warnings and Precautions ( 5.6 )] Cardiovascular Events [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.
Interactions
7 DRUG INTERACTIONS Effects of Modafinil on CYP3A4/5 Substrates The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by modafinil via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with modafinil [see Clinical Pharmacology ( 12.3 )] . The effectiveness of steroidal contraceptives may be reduced when used with modafinil and for one month after discontinuation of therapy.
Warnings
5 WARNINGS AND PRECAUTIONS Serious Rash, including Stevens-Johnson Syndrome: Discontinue modafinil at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) Angioedema and Anaphylaxis Reactions: If suspected, discontinue modafinil. ( 5.2 ) Multi-organ Hypersensitivity Reactions: If suspected, discontinue modafinil. ( 5.3 ) Persistent Sleepiness: Assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity. ( 5.4 ) Psychiatric Symptoms: Use caution in patients with a history of psychosis, depression, or mania. Consider discontinuing modafinil if psychiatric symptoms develop. ( 5.5 ) Known Cardiovascular Disease: Consider increased monitoring. 4 CONTRAINDICATIONS Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. ( 4 )
Pregnancy
8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of modafinil in pregnant women. Intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of R- and S-modafinil) and armodafinil (the R-enantiomer of modafinil). Although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. Certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Modafinil tablets, USP are available as follows: Modafinil tablets USP, 100 mg are white to off white colored capsule shaped tablets debossed with ‘M’ on one side and 100 MG on other side.
Frequently Asked Questions
What is Modafinil used for?▼
1 INDICATIONS AND USAGE Modafinil tablets are 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, modafinil tablets are 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 modafinil tablets for excessive sleepiness.
What are the side effects of Modafinil?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Serious Rash, including Stevens-Johnson Syndrome [see Warnings and Precautions ( 5.1 )] Angioedema and Anaphylaxis Reactions [see Warnings and Precautions ( 5.2 )] Multi-organ Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Persistent Sleepiness [see Warnings and Precautions ( 5.4 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.5 )] Effects on Ability to Drive and Use Machinery [see Warnings and Precautions ( 5.6 )] Cardiovascular Events [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.
Can I take Modafinil during pregnancy?▼
8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of modafinil in pregnant women. Intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of R- and S-modafinil) and armodafinil (the R-enantiomer of modafinil). Although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. Certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions.
What are the important warnings for Modafinil?▼
5 WARNINGS AND PRECAUTIONS Serious Rash, including Stevens-Johnson Syndrome: Discontinue modafinil at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) Angioedema and Anaphylaxis Reactions: If suspected, discontinue modafinil. ( 5.2 ) Multi-organ Hypersensitivity Reactions: If suspected, discontinue modafinil. ( 5.3 ) Persistent Sleepiness: Assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity. ( 5.4 ) Psychiatric Symptoms: Use caution in patients with a history of psychosis, depression, or mania. Consider discontinuing modafinil if psychiatric symptoms develop. ( 5.5 ) Known Cardiovascular Disease: Consider increased monitoring. 4 CONTRAINDICATIONS Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.