Modafinil
Wakefulness-promoting agent, FDA-approved for narcolepsy, shift work sleep disorder, OSA adjunct. DEA Schedule IV. Off-label cognitive enhancement framing separate in MolekulaX Nootropic library.
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WHAT IS MODAFINIL?
Detailed overview
Modafinil is a wakefulness-promoting agent developed by Cephalon (now Teva) (Provigil, FDA 1998). ATC code N06BA07 (CNS stimulants). Official FDA indications: narcolepsy, shift work sleep disorder (SWSD), obstructive sleep apnea (OSA) residual sleepiness adjunct. Clinically documented off-label use (cognitive enhancement, fatigue reduction, MS-associated fatigue, second-line ADHD) is detailed in the MolekulaX Nootropic library. This pharma entry focuses on official Rx indications. Mechanism: dopamine reuptake inhibitor (DAT), activation of histamine and orexin systems in the hypothalamus, selectively promoting wakefulness without the global CNS activation of classic stimulants (amphetamine, methylphenidate).
ATC code
N06BA07
Prescription
Prescription only (Rx), DEA Schedule IV (USA)
Mechanism
DAT inhibitor + histamine/orexin activation
Half-life
12-15 h
Onset
30-60 min, peak 2-4 h
Data console
Lab data
Safety
Side effects, stop signs, contraindications
Side effects · 7
- Serious skin and hypersensitivity reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, multi-organ hypersensitivity), typically in the first 1–4 weeks, FDA serious warning, stop immediately at any rash.
- Psychiatric effects: anxiety, irritability, insomnia, and less commonly mania, psychosis, hallucinations, aggression and suicidal ideation, especially with a psychiatric history.
- Cardiovascular effects: mild increases in blood pressure and heart rate, palpitations, rarely chest pain and arrhythmia; blood pressure monitoring advised.
- Headache (the most common, around 35%), usually easing after the first week.
- Nausea, dry mouth, decreased appetite and weight loss.
- Insomnia if dosed too late in the day (around ≥2 pm), so once-daily morning dosing is recommended.
- Psychological dependence and abuse potential (DEA Schedule IV, low but not zero), especially when tied to performance expectations; physical tolerance is rare.
Contraindications · 4
- Prior severe skin reaction (Stevens-Johnson syndrome, TEN, DRESS) history
- Severe CV disease: LV hypertrophy, mitral valve prolapse with IHSS
- Known modafinil hypersensitivity
- Psychosis, severe anxiety disorder (relative)
Related Pharmaceuticals
Same therapeutic category
Studies
Related research and clinical findings
Comparative efficacy of new wake-promoting agents for narcolepsy-a network meta-analysis.
Yan Z, Li J, Yu Y
The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy.
Black JE, Hull SG, Tiller J, Yang R, Harsh JR
Modafinil in the treatment of multiple sclerosis-related fatigue
Rammohan KW, Rosenberg JH, Lynn DJ et al.
Sustained efficacy of armodafinil in shift work disorder
Czeisler CA, Walsh JK, Wesnes KA et al.
Cognitive effects of modafinil in normal healthy people: a systematic review
Battleday RM, Brem AK.
Sodium oxybate plus modafinil in narcolepsy with cataplexy
Black J, Houghton WC.
Long-term efficacy and safety of modafinil (PROVIGIL((R))) for the treatment of excessive daytime sleepiness associated with narcolepsy.
Mitler MM, Harsh J, Hirshkowitz M, Guilleminault C
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Have a question about Modafinil?
Educational drug info from official sources (PubMed, FDA, EMA). Does NOT replace medical consultation or the SmPC. Talk to your doctor!
The information here is for educational and scientific purposes only. Medication use requires medical consultation and a prescription. The indications, dose ranges, and side effects listed here do NOT replace the official Summary of Product Characteristics (SmPC) or consultation with a physician. Do not start or stop any medication on your own. In an emergency, call your local emergency number.