Modafinil

Provigil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy. Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.

ALERTEC (modafinil) is indicated for: • The symptomatic treatment of excessive sleepiness in adult patients with narcolepsy. In narcolepsy, ALERTEC has no significant effect on cataplexy. • The symptomatic treatment of excessive sleepiness in adult patients with obstructive sleep apnea (OSA).

In OSA, ALERTEC is indicated as an adjunct to successful standard treatment(s) for the underlying obstruction, when excessive sleepiness persists. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient with OSA, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating ALERTEC.

If ALERTEC is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. • The symptomatic treatment of excessive sleepiness in adult patients with circadian rhythm sleep disorder, shift work type (shift work disorder) (SWD).

In SWD, ALERTEC (modafinil) is indicated for the symptomatic treatment of excessive sleepiness (as confirmed by multiple sleep latency test) associated with loss of a normal sleep-wake pattern (as confirmed by polysomnography). Daytime sleep (as measured by polysomnography) in SWD is not affected by the use of ALERTEC.

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.

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). ( 1 ) Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.