From the Guidelines
Modafinil is recommended for the treatment of narcolepsy, idiopathic hypersomnia, and other sleep disorders, with a standard dosage of 200 mg taken once daily, due to its effectiveness in improving excessive daytime sleepiness, disease severity, and quality of life, as supported by strong evidence from recent studies 1. The medication has been shown to be effective in reducing excessive daytime sleepiness and improving disease severity in patients with narcolepsy and idiopathic hypersomnia, with a moderate overall quality of evidence 1.
- The benefits of modafinil use in patients with these conditions outweigh the risks and adverse events, with commonly reported adverse events including insomnia, nausea, diarrhea, headache, and dry mouth 1.
- Modafinil may also be used for the treatment of hypersomnia secondary to Parkinson’s disease and traumatic brain injury, although the evidence is conditional and the balance of risks and harms should be carefully considered in these cases 1.
- The medication is an FDA Schedule IV federally controlled substance due to its potential for abuse or dependency, and may cause fetal harm or reduce the effectiveness of oral contraception, highlighting the need for careful patient selection and monitoring 1.
- Alternative birth control methods should be used during treatment and for one month after discontinuation, and the medication should be used cautiously in patients with liver impairment, psychiatric disorders, or a history of substance abuse 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). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. The guidelines for using Modafinil (Provigil) for treating sleep disorders are to improve wakefulness in adult patients with:
- Narcolepsy
- Obstructive sleep apnea (OSA): to treat excessive sleepiness, not the underlying obstruction
- Shift work disorder (SWD) It is recommended that a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness in OSA patients 2.
From the Research
Guidelines for Using Modafinil
- Modafinil is a wake-promoting agent approved for the treatment of excessive sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD), and narcolepsy 3, 4, 5.
- The recommended dosage of modafinil is 200 or 400 mg/day, given once or twice daily (morning and midday) to patients with narcolepsy 6.
- Modafinil is generally well tolerated in patients with OSA/HS or SWSD and has a low abuse potential 4.
- Common adverse events with modafinil include insomnia, headache, nausea, nervousness, and hypertension 7.
- Modafinil does not affect sleep architecture in any patient population according to polysomnography 3.
Specific Conditions
- For patients with OSA, modafinil is recommended for use as an adjunct to standard therapies that treat the underlying airway obstruction 5.
- In patients with SWD, modafinil reduces the maximum level of sleepiness during night shift work, level of sleepiness during the commute home, and incidence of accidents or near-accidents during the commute home when compared with placebo 5.
- Modafinil is effective in the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy, although it is not effective against cataplexy 6.
Safety and Interactions
- Modafinil induces and inhibits several cytochrome P450 isoenzymes and has the potential for interacting with drugs from all classes 7.
- The modafinil dose should be reduced in the elderly and in patients with hepatic disease 7.
- Caution is needed in patients with severe renal insufficiency because of substantial increases in levels of modafinil acid 7.