Source: FDA, National Drug Code (US) Revision Year: 2020
NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
In OSA, NUVIGIL is 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 NUVIGIL for excessive sleepiness.
The recommended dosage of NUVIGIL for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.
In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].
The recommended dosage of NUVIGIL for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
In patients with severe hepatic impairment, the dosage of NUVIGIL should be reduced [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
Fatal overdoses involving modafinil alone or involving NUVIGIL or modafinil in combination with other drugs have been reported in the postmarketing setting. Symptoms most often accompanying NUVIGIL or modafinil overdose, alone or in combination with other drugs, have included anxiety, dyspnea, insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.
No specific antidote exists for the toxic effects of a NUVIGIL overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.
Store at 20°-25°C (68°-77°F).
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