PREGNANCY AND BREASTFEEDING SAFETY: There are no adequate studies that assess effects of modafinil in pregnant women. Intrauterine growth retardation and spontaneous abortion have been reported.
It is not known if modafinil is excreted in human milk.
STORAGE: Modafinil should be stored at room temperature, 15 C - 30 C (59 F - 86 F).
DOSING: The recommended dose is 200 mg once daily not to exceed 400 mg. It should be administered in the morning for treating narcolepsy or obstructive sleep apnea, and one hour prior to work in those with shift work disorder. It can be taken with or without food. The 400 mg dose may not be more effective than the 200 mg dose.
DRUG CLASS AND MECHANISM: Modafinil is an oral drug that is used for improving wakefulness in patients with excessive sleepiness. It is similar to armodafinil (Nuvigil). Like amphetamines, modafinil promotes wakefulness by stimulatIng the brain. The exact mechanism of action of modafinil is unknown. It may work by increasing the amount of dopamine (a chemical neurotransmitter that nerves use to communicate with each other) in the brain by reducing the reuptake of dopamine into nerves. Modafinil was approved by the FDA in December 1998.
Medically reviewed by Eni Williams, PharmD
Reference: FDA Prescribing Information
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