From the Guidelines
Modafinil is a highly effective treatment for excessive sleepiness and fatigue, and its use is recommended for patients with narcolepsy, obstructive sleep apnea, and shift work sleep disorder, as well as for those with cancer-related fatigue, hypersomnia secondary to Parkinson's disease, and hypersomnia secondary to traumatic brain injury, with a typical dosage ranging from 100-200mg taken once daily, as supported by the most recent and highest quality study 1.
Key Points
- Modafinil works by affecting certain brain chemicals that control the sleep-wake cycle, promoting wakefulness without the jitteriness or anxiety often associated with stimulants.
- Common side effects include headache, nausea, nervousness, and insomnia.
- Modafinil can reduce the effectiveness of hormonal contraceptives, so alternative birth control methods should be considered.
- This medication requires a prescription and should only be taken under medical supervision, as it has potential for dependence and may interact with other medications.
- Patients with heart, liver, or kidney problems should use modafinil with caution, and it's not recommended for those with a history of stimulant abuse or certain psychiatric conditions.
Evidence Summary
The American Academy of Sleep Medicine clinical practice guideline 1 recommends the use of modafinil for the treatment of narcolepsy in adults, with a strong recommendation based on moderate-quality evidence. Additionally, the guideline suggests the use of modafinil for the treatment of hypersomnia secondary to Parkinson's disease 1 and hypersomnia secondary to traumatic brain injury 1, with conditional recommendations based on moderate-quality evidence. The use of modafinil for cancer-related fatigue is also supported by evidence, with studies showing significant improvements in fatigue levels and quality of life 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Overview of Modanifil
- Modafinil is a wake-promoting agent used to treat excessive sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD), and narcolepsy 2, 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 who are receiving nasal continuous positive airway pressure (nCPAP) therapy 3, 5.
Efficacy of Modanifil
- Modafinil has been shown to improve objectively determined sleep latency, overall clinical condition related to severity of sleepiness, and reduce patient-reported sleepiness in patients with OSA, SWD, and narcolepsy 2, 3, 5.
- It has also been found to improve wakefulness, behavioral alertness, functional status, and health-related quality of life in these patients 2, 3.
- In patients with SWD, modafinil has been shown to reduce 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 2.
Safety and Tolerability of Modanifil
- Modafinil is generally well tolerated in patients with OSA, SWD, and narcolepsy, with a low abuse potential 2, 3, 6.
- Common adverse events associated with modafinil include headache, nausea, and nervousness, but these are typically mild and transient 6, 5.
- Modafinil does not appear to affect nighttime sleep or nCPAP use in patients with OSA 5.
Pharmacology and Mechanism of Action
- The exact mechanism of action of modafinil is not fully understood, but it is thought to indirectly increase wakefulness through inhibition of cortical γ-aminobutyric acid (GABA) release via serotonergic mechanisms 6.
- Modafinil has a linear and dose-dependent pharmacokinetic profile, with a half-life of 9-14 hours 6.