From the Guidelines
Modafinil is a wakefulness-promoting agent primarily prescribed for the treatment of excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder 1.
Key Uses
- The recommended dose is 200mg taken orally once daily, with or without food, and can be adjusted to a maximum of 400mg per day if necessary 1.
- Treatment typically begins with a single dose in the morning, and its efficacy has been demonstrated in clinical trials to last for up to 12 hours, with a duration of treatment that is often long-term, sometimes indefinite, depending on the underlying condition being managed.
Additional Considerations
- Modafinil has also been used off-label for the treatment of cancer-related fatigue, although more research is needed to fully understand its efficacy in this context 1.
- Common side effects include headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia 1.
- It is essential to note that modafinil is a Schedule IV federally controlled substance due to its potential for abuse or dependency, and its use should be carefully monitored 1.
From the FDA Drug Label
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). In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
The use of Modafinil (Provigil) is to improve wakefulness in adult patients with:
- Narcolepsy
- Obstructive sleep apnea (OSA): to treat excessive sleepiness, not the underlying obstruction
- Shift work disorder (SWD) 2
From the Research
Uses of Modafinil (Provigil)
- Modafinil is a wake-promoting agent used to treat excessive sleepiness associated with narcolepsy, obstructive sleep apnoea/hypopnoea syndrome (OSA/HS), and shift work sleep disorder (SWSD) 3, 4.
- It is approved for use in the US and certain European countries as an adjunctive therapy in patients with residual excessive sleepiness associated with OSA/HS who are receiving nasal continuous positive airway pressure (nCPAP) therapy 3.
- Modafinil improves night-time wakefulness without disrupting daytime sleep in patients with SWSD 3.
- It is also used to treat excessive daytime sleepiness associated with narcolepsy, and as an adjunctive treatment in patients with obstructive sleep apnea syndrome who have residual daytime sleepiness despite optimal treatment with continuous positive airway pressure 4.
- Additionally, modafinil has been shown to be beneficial in enhancing cognition in patients with prolonged disorders of consciousness, particularly those with traumatic brain injury 5.
Comparison with Other Treatments
- Modafinil has a different pharmacokinetic profile compared to armodafinil, with armodafinil maintaining higher plasma concentrations later in the day 6.
- Armodafinil, the R-isomer of racemic modafinil, has been shown to be effective in treating excessive sleepiness associated with OSA, SWD, and narcolepsy, and may be a particularly appropriate therapy for patients with persistent excessive sleepiness 7.