Armodafinil
Generic Name: armodafinil
Brand Names:
Armodafinil
11 DESCRIPTION Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35.
Overview
11 DESCRIPTION Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35.
Uses
1 INDICATIONS AND USAGE Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil 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 armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage of armodafinil tablets for each indication is as follows: • OSA or Narcolepsy: 150 mg to 250 mg once a day in the morning. ( 2.1 ) • SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift. ( 2.2 ) • Hepatic Impairment: reduced dose in patients with severe hepatic impairment. ( 2.3 , 12.3 ) • Geriatric Patients: consider lower dose. ( 2.4 , 12.3 ) 2.1 Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy The recommended dosage of armodafinil tablets for patients with OSA or narcolepsy is 150 mg to 250 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 below and elsewhere in the labeling: • Serious Dermatologic Reactions [see Warnings and Precautions (5.1) ] • Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.2) ] • Angioedema and Anaphylaxis 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, dizziness, and insomnia.
Interactions
7 DRUG INTERACTIONS Effects of Armodafinil Tablets 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 armodafinil tablets 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 armodafinil tablets [see Clinical Pharmacology (12.3) ] . The effectiveness of steroidal contraceptives may be reduced when used with armodafinil tablets and for one month after discontinuation of therapy.
Warnings
5 WARNINGS AND PRECAUTIONS • Serious Rash, including Stevens-Johnson Syndrome: discontinue armodafinil tablets at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) • DRESS/Multi-organ Hypersensitivity Reactions: if suspected, discontinue armodafinil tablets. (5.2) • Angioedema and Anaphylaxis Reactions: if suspected, discontinue armodafinil tablets. (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 particular caution in treating patients with a history of psychosis, depression, or mania. Consider discontinuing armodafinil tablets if psychiatric symptoms develop. 4 CONTRAINDICATIONS Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or their inactive ingredients [see Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. Intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and modafinil. Although the pharmacology of armodafinil is not identical to that of the sympathomimetic amines, armodafinil shares some pharmacologic properties with this class [see Clinical Pharmacology (12.1) ]. Some sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Armodafinil Tablets containing 150 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and A32 on the other side. They are available as follows: NDC 71335-2991-1: 30 Tablets in a BOTTLE NDC 71335-2991-2: 28 Tablets in a BOTTLE NDC 71335-2991-3: 90 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F).
Frequently Asked Questions
What is Armodafinil used for?▼
1 INDICATIONS AND USAGE Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil 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 armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
What are the side effects of Armodafinil?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Serious Dermatologic Reactions [see Warnings and Precautions (5.1) ] • Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.2) ] • Angioedema and Anaphylaxis 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, dizziness, and insomnia.
Can I take Armodafinil during pregnancy?▼
8.1 Pregnancy Risk Summary Limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. Intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and modafinil. Although the pharmacology of armodafinil is not identical to that of the sympathomimetic amines, armodafinil shares some pharmacologic properties with this class [see Clinical Pharmacology (12.1) ]. Some sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions.
What are the important warnings for Armodafinil?▼
5 WARNINGS AND PRECAUTIONS • Serious Rash, including Stevens-Johnson Syndrome: discontinue armodafinil tablets at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) • DRESS/Multi-organ Hypersensitivity Reactions: if suspected, discontinue armodafinil tablets. (5.2) • Angioedema and Anaphylaxis Reactions: if suspected, discontinue armodafinil tablets. (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 particular caution in treating patients with a history of psychosis, depression, or mania. Consider discontinuing armodafinil tablets if psychiatric symptoms develop. 4 CONTRAINDICATIONS Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or their inactive ingredients [see Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Armodafinil tablets are 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.