Modafinil

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. …

• The recommended dosage of modafinil tablets for each indication is as follows: • Narcolepsy or OSA: 200 mg once a day in the morning. • SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift. • Severe Hepatic Impairment: reduce dose to half the recommended dose. • Geriatric Patients: consider lower dose
• 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
• 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 [see Clinical Pharmacology and Clinical Studies ]
• Dosage in Shift Work Disorder (SWD) The recommended dosage of modafinil tablets 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 modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see Use in Specific Populations and Clinical Pharmacology ]
• 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 ]

100 mg – white to off white colored capsule shaped tablets debossed with ‘M’ on one side and 100 MG on other side. 200 mg – white to off white colored capsule shaped tablets debossed with ‘M’ on one side and 200 MG on other side with a breakline between 200 and MG. Tablets: 100 mg and 200 mg. ()

• Safety and effectiveness
• In pediatric patients have not been established
• Modafinil is not approved in this population for any indication
• Serious skin rashes, including erythema multiforme major (EMM) and Stevens-Johnson Syndrome (SJS) have been associated with modafinil use
• In pediatric patients [see Warnings and Precautions ]
• In a controlled 6 week study, 165
• Pediatric patients (aged 5 to 17 years) with narcolepsy were treated with modafinil (n=123), or placebo (n=42). …

In clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Allergic Reactions Advise patients to stop taking modafinil tablets and to notify their physician right away if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing, or a related allergic phenomenon
• Driving and Dangerous Activities Advise patients not to alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with modafinil tablets has been shown to produce levels of wakefulness that permit such activities. …

• Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions ]
• Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. ()

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. …

• 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. …

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 pai …

8.1 Pregnancy Teratogenic Effects 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). …

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 modafinil) 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. …

9.1 Controlled Substance Modafinil tablets contain modafinil, a Schedule IV controlled substance. 9.2 Abuse In humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants. In in vitr o binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.