Recommended Dosage of Nuvigil (Armodafinil) for Adults
The recommended dosage of armodafinil (Nuvigil) for adults with narcolepsy or obstructive sleep apnea is 150 mg to 250 mg taken orally once daily as a single dose in the morning. 1
Dosing Guidelines
- The standard starting dose is 150 mg once daily in the morning for most adults with narcolepsy 1
- Doses up to 250 mg/day have been well tolerated, but there is no consistent evidence that these higher doses provide additional benefit beyond the 150 mg/day dose 1
- For shift work disorder, the recommended dose is 150 mg taken approximately 1 hour prior to the start of the work shift 1
- The medication should be administered as a single daily dose rather than divided doses 1, 2
Special Populations
- For elderly patients, consideration should be given to using lower doses (starting at 100 mg) with close monitoring 1, 3
- In patients with severe hepatic impairment, the dosage should be reduced 1
- Armodafinil is contraindicated in pregnancy based on animal data showing potential fetal harm, though human data are insufficient to determine risk 4
- The medication may reduce the effectiveness of oral contraceptives 4
Pharmacokinetic Considerations
- Armodafinil is readily absorbed with peak plasma concentrations reached around 2 hours after administration in the fasted state 5
- Food does not affect the overall bioavailability but may delay peak concentration by approximately 2-4 hours 5
- The medication exhibits linear pharmacokinetics over the 50-400 mg dose range 5
- Steady state is typically reached within 7 days of daily dosing 5
- Armodafinil has a mean elimination half-life of approximately 15 hours 5, 6
- Compared to modafinil, armodafinil maintains higher plasma concentrations later in the day on a milligram-to-milligram basis 6
Efficacy and Monitoring
- Armodafinil has been shown to significantly improve wakefulness and reduce excessive daytime sleepiness in patients with narcolepsy 7, 2
- The American Academy of Sleep Medicine suggests armodafinil as a treatment option for narcolepsy in adults (conditional recommendation) 4
- Efficacy assessments can include the Clinical Global Impression of Change (CGI-C), Brief Fatigue Inventory (BFI), and Epworth Sleepiness Scale (ESS) 2
- Improvements in wakefulness typically begin within the first month of treatment and can be maintained long-term 2
Safety and Adverse Effects
- Armodafinil is generally well tolerated, with most adverse events being mild to moderate in intensity 2
- The most common adverse effects include headache (25%), nasopharyngitis (17%), and insomnia (14%) 2
- Modest increases in vital signs may occur (blood pressure [3.6/2.3 mm Hg], heart rate [6.7 beats per minute]), with most changes occurring within the first 3 months of treatment 2
- Armodafinil is an FDA Schedule IV controlled substance due to its potential for abuse or dependency 4
- Regular monitoring of blood pressure is recommended for patients on armodafinil 2
Important Precautions
- Armodafinil should be used with caution in patients with cardiovascular disease, as it may cause modest increases in blood pressure and heart rate 2
- The medication may reduce the effectiveness of hormonal contraceptives, necessitating alternative birth control methods 4
- A 2018 report from the armodafinil/modafinil pregnancy registry showed higher rates of major congenital anomalies in children exposed to the drug in utero 4