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Provigil (modafinil)
Provigil works by increasing the activity of certain neurotransmitters in the brain, such as dopamine, to help regulate sleep-wake cycles.
Provigil (modafinil) is a sympathomimetic-like agent developed by CEPHALON and currently owned by Nuvo Pharms. It targets the D(2) dopamine receptor and is used to treat various sleep disorders, including hypersomnia, narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Approved by the FDA in 1998, modafinil is now off-patent with multiple generic manufacturers. Its long half-life of 40 hours and high bioavailability of 80% contribute to its efficacy. Key safety considerations include its potential for abuse and interactions with other medications.
At a glance
| Generic name | modafinil |
|---|---|
| Sponsor | Nuvo Pharms |
| Drug class | Sympathomimetic-like Agent [EPC] |
| Target | D(2) dopamine receptor |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1998 |
Mechanism of action
Mechanism of Action and Pharmacology. The precise mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents like amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of sympathomimetic amines. Modafinil has weak to negligible interactions with receptors for norepinephrine, serotonin, dopamine, GABA, adenosine, histamine-3, melatonin, and benzodiazepines. Modafinil also does not inhibit the activities of MAO-B or phosphodiesterases II to V. Modafinil-induced wakefulness can be attenuated by the 1-adrenergic receptor antagonist prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to -adrenergic agonists, such as the rat vas deferens preparation. Modafinil is not direct- or indirect-acting dopamine receptor agonist. However, in vitro, modafinil binds to the dopamine transporter and inhibits dopamine reuptake. This activity ha
Approved indications
- Hypersomnia
- Narcolepsy
- Sleepiness Due To Obstructive Sleep Apnea
- Sleepiness Due To Shift Work Sleep Disorder
Common side effects
- Headache
- Nausea
- Back Pain
- Diarrhea
- Dyspepsia
- Anxiety
- Insomnia
- Dizziness
- Nervousness
- Rhinitis
- Flu Syndrome
- Chest Pain
Drug interactions
- triazolam
Key clinical trials
- Cognitive Strategies in Early Psychosis 2 (PHASE3)
- Cognitive Strategies in Early Psychosis 1 (PHASE3)
- RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) (PHASE2)
- RECOVER-SLEEP: Platform Protocol (PHASE2)
- Modafinil and Cognitive Function in POTS (EARLY_PHASE1)
- Modafinil to Improve Fatiguability (PHASE1,PHASE2)
- Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial (PHASE2)
- Investigation of Locus Coeruleus Function in Sustained Attention (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Provigil CI brief — competitive landscape report
- Provigil updates RSS · CI watch RSS
- Nuvo Pharms portfolio CI