What is the use of Modafinil (Provigil)?

From the Guidelines

Modafinil is recommended for the treatment of narcolepsy in adults, as it has been shown to improve excessive daytime sleepiness, disease severity, and quality of life, with a moderate quality of evidence 1. The medication is typically used to treat excessive sleepiness associated with narcolepsy, shift work sleep disorder, and obstructive sleep apnea.

Key Points

• The typical dosage ranges from 100-200mg taken once daily in the morning for narcolepsy and obstructive sleep apnea, or about one hour before starting a shift for shift work sleep disorder.
• Modafinil works by affecting certain brain chemicals that control the sleep/wake cycle, though its exact mechanism isn't fully understood.
• It's classified as a wakefulness-promoting agent rather than a traditional stimulant.
• Common side effects include headache, nausea, nervousness, anxiety, and insomnia.
• Modafinil can reduce the effectiveness of hormonal contraceptives, so alternative birth control methods should be used during treatment and for one month after stopping.
• It has potential for dependence and is a controlled substance in many countries.
• Patients should avoid alcohol while taking modafinil and should disclose all other medications to their doctor before starting treatment to prevent potentially dangerous drug interactions.

Considerations

• The balance of risks and harms is likely different for pregnant and breastfeeding women, and the use of modafinil in these populations should be carefully considered 1.
• The costs of the medication are likely to vary, but the majority of patients would most likely use modafinil compared to no treatment for their narcolepsy.
• While modafinil has been used off-label for the treatment of cancer-related fatigue, the evidence for this indication is not as strong as for narcolepsy, and its use in this context should be individualized 1.

From the FDA Drug Label

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). Modafinil tablets are a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders: narcolepsy, obstructive sleep apnea (OSA), shift work disorder (SWD).

The use of Modafinil (Provigil) is to improve wakefulness in adult patients with excessive sleepiness associated with:

• Narcolepsy
• Obstructive sleep apnea (OSA): to treat excessive sleepiness, but not the obstruction or medical condition that is causing OSA
• Shift work disorder (SWD) 2

From the Research

Use of Modafinil (Provigil)

• Modafinil is a wake-promoting agent used to improve wakefulness in patients with excessive sleepiness associated with shift work sleep disorder, obstructive sleep apnea, or narcolepsy 3, 4, 5, 6.
• It is approved for use in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnoea syndrome, or shift work sleep disorder 4, 5, 6.
• Modafinil is effective in reducing excessive daytime sleepiness and improving wakefulness in patients with these conditions, but it may not completely normalize sleepiness measures 3, 5.
• The drug has a low abuse potential and is generally well tolerated, with common adverse events including headache, nausea, and infection 3, 7.

Conditions Treated with Modafinil

• Narcolepsy: Modafinil is effective in reducing excessive daytime sleepiness, but it does not suppress cataplexy 7, 5.
• Obstructive sleep apnea/hypopnoea syndrome: Modafinil is used as an adjunct to standard therapies, such as continuous positive airway pressure, to treat residual excessive sleepiness 4, 5, 6.
• Shift work sleep disorder: Modafinil improves night-time wakefulness and reduces sleepiness during night shift work, without disrupting daytime sleep 4, 6.

Pharmacology and Tolerability

• Modafinil promotes wakefulness through an unknown mechanism, possibly involving inhibition of cortical γ-aminobutyric acid release via serotonergic mechanisms 7.
• The drug has a linear and dose-dependent pharmacokinetic profile, with a half-life of 9-14 hours 7.
• Modafinil is well tolerated, with a low incidence of serious adverse events and no significant effects on cardiovascular or sleep parameters 3, 7, 6.