From the Guidelines
Modafinil is recommended at a dose of 200 mg daily for the treatment of sleep disorders, including narcolepsy, obstructive sleep apnea, and shift work sleep disorder, as it has been shown to be effective in reducing fatigue and improving wakefulness. The dosage and usage of Modafinil (Provigil) can vary depending on the specific sleep disorder being treated, but generally, it is taken once daily in the morning. Some patients may respond to lower doses of 100 mg, while others might require up to 400 mg daily, though this higher dose is less common 1.
Key Considerations
- The medication should be taken at the same time each day, with or without food, though taking it with food may delay its effects slightly.
- For shift work sleep disorder specifically, the dose should be taken about one hour before the start of the work shift.
- Patients with liver impairment or elderly patients often start at 100 mg daily.
- Modafinil works by affecting certain neurotransmitters in the brain that regulate wakefulness, particularly histamine and orexin/hypocretin, though its exact mechanism isn't fully understood 1.
- It typically begins working within a few hours and has effects lasting several hours, with a half-life of approximately 15 hours 1.
Safety and Efficacy
- Modafinil has been shown to be well-tolerated, with common adverse events including headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia 1.
- Studies have demonstrated its efficacy in reducing fatigue and improving quality of life in patients with cancer-related fatigue, multiple sclerosis, and other conditions 1.
- However, patients should be monitored for rare but serious skin reactions, psychiatric symptoms, and potential drug interactions, especially with hormonal contraceptives which may become less effective during treatment.
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). The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning The recommended dosage of modafinil tablets for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
The recommended dosage and usage of Modafinil (Provigil) for treating sleep disorders is:
- 200 mg once a day for patients with narcolepsy or obstructive sleep apnea (OSA), taken in the morning.
- 200 mg once a day for patients with shift work disorder (SWD), taken 1 hour prior to the start of their work shift. 2
From the Research
Modafinil Pharmacology
- Modafinil is a wake-promoting agent that is pharmacologically distinct from CNS stimulants, such as amfetamine, dexamfetamine, and methylphenidate 3.
- It is approved for use in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea/hypopnoea syndrome (OSA/HS), or shift work sleep disorder (SWSD) 3, 4.
Recommended Dosage and Usage
- The recommended dosage of modafinil is 200 or 400 mg/day, given once or twice daily (morning and midday) to patients with narcolepsy 5.
- For patients with OSA/HS, modafinil is recommended as an adjunct to standard therapies that treat the underlying airway obstruction 4.
- In patients with SWD, modafinil can be taken before night shifts to improve wakefulness and reduce sleepiness 6, 4.
Efficacy and Tolerability
- Modafinil has been shown to be effective in improving wakefulness and reducing excessive daytime sleepiness in patients with narcolepsy, OSA/HS, and SWD 3, 5, 6, 4.
- It is generally well tolerated, with a low abuse potential and minimal adverse effects, such as headache and nausea 3, 5, 6, 4.
- Modafinil does not adversely affect cardiovascular parameters or scheduled sleep, and it can improve behavioral alertness, functional status, and health-related quality of life 4.
Pharmacokinetics
- Modafinil is extensively biotransformed in the liver to inactive metabolites, which are then eliminated primarily in the urine 5.
- The pharmacokinetics of modafinil are linear and dose-dependent, with a peak plasma concentration reached 2-3 hours after oral administration 5.
- The elimination half-life of modafinil is 9-14 hours, and it is not significantly affected by age or food intake, but it may be increased in patients with hepatic or renal impairment 5.