WAKLERT contains armodafinil, the active R-enantiomer of modafinil, used to promote wakefulness. Its mechanism involves effects on the central nervous system, although the precise mechanism by which armodafinil promotes wakefulness has not been fully established. Armodafinil has a longer elimination half-life than the S-enantiomer of modafinil. (FDA Access Data)
The medication may be used in adults:
In obstructive sleep apnea, armodafinil is intended to treat excessive sleepiness and does not treat the underlying airway obstruction. (FDA Access Data)
Armodafinil has been evaluated in clinical development programs involving three major conditions: narcolepsy, obstructive sleep apnea, and shift work disorder. Clinical studies assessed wakefulness and the ability to remain alert during periods when patients would otherwise experience significant sleepiness. FDA-reviewed clinical data included four efficacy studies covering these three indications. Overall, the evidence demonstrated treatment effects in the targeted sleep disorders, although the regulatory review also identified concerns regarding aspects of the original statistical analyses. (FDA Access Data)
Armodafinil is a prescription medication and is classified as a Schedule IV controlled substance in the United States, requiring appropriate medical supervision. (FDA Access Data)
The medication is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, or shift work disorder.
Armodafinil is used to reduce excessive daytime sleepiness and promote wakefulness. In obstructive sleep apnea, it does not replace treatment directed at the underlying airway obstruction, such as positive airway pressure therapy when prescribed.
The medication is taken orally strictly according to a healthcare professional's instructions. For narcolepsy and excessive sleepiness associated with obstructive sleep apnea, standard regimens use once-daily morning administration; for shift work disorder, it is generally taken approximately one hour before the beginning of the work shift. The specific dose and timing should be determined by the prescribing physician based on the diagnosis, comorbidities, and individual response.
Side Effects
Patients should seek immediate medical attention if severe rash, facial or tongue swelling, difficulty breathing, severe psychiatric symptoms, or other signs of a serious allergic reaction occur. Serious dermatologic and hypersensitivity reactions are recognized risks associated with armodafinil therapy.
