PROVIGIL (modafinil)
Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). In patients with OSA, the medication is intended to treat the symptom of sleepiness rather than the underlying physical airway obstruction. For patients where continuous positive airway pressure (CPAP) is the treatment of choice, a maximal effort to optimize CPAP therapy should be made prior to and during the use of Provigil.
How PROVIGIL Works
The precise mechanism of modafinil is unknown, though its wake-promoting actions are similar to sympathomimetic agents like amphetamine, albeit with a distinct pharmacologic profile. Modafinil binds to the dopamine transporter (DAT) and inhibits dopamine reuptake, resulting in increased extracellular dopamine levels; research in DAT-deficient models suggests its wake-promoting activity is DAT-dependent. Unlike traditional stimulants that cause widespread neuronal activation, modafinil appears to target more discrete brain regions. Additionally, while modafinil is not a direct receptor agonist, its effects can be attenuated by $\alpha$1-adrenergic antagonists.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-12-24
- Routes
- ORAL
- Dosage Forms
- TABLET
PROVIGIL Approval History
What PROVIGIL Treats
3 indicationsPROVIGIL is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Narcolepsy
- Obstructive Sleep Apnea
- Shift Work Disorder
PROVIGIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PROVIGIL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PROVIGIL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PROVIGIL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
52 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07582458 MODIFI-IBD | MODIBD656 2026-525163-41-00 | Ph 2, Ph 3 | not yet recruiting | Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease: a Multicentre,Randomised, Double-blind, Placebo-controlled, Clinical Trial (MODIFI-IBD Trial) |
| NCT07263022 COSTEP 2 | STUDY00025575 P50MH119569 | Ph 3 | not yet recruiting | Cognitive Strategies in Early Psychosis 2 |
| NCT07231497 COSTEP 1 | STUDY00025500 P50MH119569 | Ph 3 | recruiting | Cognitive Strategies in Early Psychosis 1 |
| NCT06404099 | Pro00112484_A OTA-21-015G | Ph 2 | active not recruiting | RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) |
| NCT06404086 | Pro00112484 OTA-21-015G | Ph 2 | completed | RECOVER-SLEEP: Platform Protocol |
| NCT05333250 MODIFY | 663439 | Ph 1, Ph 2 | recruiting | Modafinil to Improve Fatiguability |
| NCT07295834 MFI | 344329 M-2024-2 Moulton, Jon Moulton Charity Trust | Ph 2 | not yet recruiting | Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial |
| NCT06041048 LC | 1939774 | Ph 4 | recruiting | Investigation of Locus Coeruleus Function in Sustained Attention |
| NCT06665230 | 6552-005 MK-6552-005 | Ph 1 | completed | A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005) |
| NCT06619665 | 6552-003 MK-6552-003 | Ph 1 | completed | A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003) |
| NCT03864042 results posted | ARRAY-818-103 C4221003, 2019-001036-66 | Ph 1 | completed | Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors |
| NCT03772314 results posted | IRB00108167 | Ph 2 | completed | Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia |
| NCT02896712 results posted | HSC-MS-15-0595 | Ph 2 | completed | Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention |
| NCT03621761 COMBO-MS results posted | HUM00143319 | Ph 4 | completed | Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue |
| NCT02538744 | H36362 | Ph 1 | completed | Complementary Combination Therapy for Cocaine Dependence |
| NCT03616717 | 4UH3MH109168-03 | Ph 4 | completed | Modafinil Effects on EEG Biomarkers of Reward and Motivation |
| NCT00838981 results posted | 0705002636 R01DA021264, DPMC | Ph 1, Ph 2 | completed | Pharmacotherapy & CM for Opioid and Cocaine Dependence |
| NCT01381718 results posted | SCUSF 0901 SCUSF-0901, ACCL0922 | Ph 2 | completed | Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor |
| NCT03522506 results posted | TAK-925-1002 U1111-1211-2133 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults |
| NCT03185065 TRIUMPHANT-MS results posted | IRB00119702 | Ph 3 | completed | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis |
| NCT00838227 | 07I/C41-00 | Ph 2 | withdrawn | Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder |
| NCT03424681 results posted | FP00002746 | Ph 2 | completed | Modafinil for the Treatment of Alcohol Use Disorders |
| NCT01913327 APD results posted | 2010489 | Ph 4 | terminated | Antipsychotic Effects on Brain Function in Schizophrenia |
| NCT04317001 T-CID | 46217 | Ph 3 | withdrawn | Treatment for Cognitive Impairment in Depression |
| NCT00626210 results posted | 8564 | Ph 4 | terminated | Modafinil Treatment for Sleep/Wake Disturbances in Older Adults |
| NCT03620253 | MOCOG-01 | Ph 3 | terminated | Modafinil's Effects on Cognition in Remitted MDD |
| NCT02494102 ModOSA results posted | CAPITALSTUDY00002957 | Ph 4 | terminated | Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea |
| NCT00751023 results posted | HR#18440 | Ph 4 | completed | Effects of Modafinil in Methamphetamine Dependence |
| NCT02155257 results posted | IRB00028525 | Ph 4 | completed | Pain Expectations in Subjects With Osteoarthritis |
| NCT01092780 results posted | 7288-010 MK-7288-010 | Ph 1 | completed | Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010) |
| NCT00613015 results posted | R01DA021690 R01DA021690 | Ph 2 | completed | Stress and Medication Effects on Cocaine Cue Reactivity |
| NCT01965925 | GCO 12-1573 R34MH101267 | Ph 4 | completed | Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil |
| NCT02857244 | IRB15-1577 | Ph 2 | withdrawn | A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients |
| NCT00859573 results posted | P50 DA018197-104386 P50DA018197 | Ph 2 | terminated | Modafinil for Methamphetamine Dependence |
| NCT03182413 | THN102-102 | Ph 1 | completed | Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation |
| NCT02028260 | 2013P002105 | Ph 3 | withdrawn | Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill |
| NCT01085903 results posted | 110644 R21HD055677 | Ph 2 | completed | Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia |
| NCT01137396 results posted | 0911005989 DA011744-08 | Ph 2 | completed | Modafinil, Sleep Architecture and Cocaine Relapse |
| NCT02603861 | 15511 I7S-EW-HBEB | Ph 1 | completed | A Study of LY3154207 on Sleep in Healthy Male Participants |
| NCT01800097 | ModaA001 | Ph 3 | terminated | Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent |
| NCT01461174 | WP1P001 2011-000344-25 | Ph 1 | completed | Effects of Donepezil and Memantine on Cognitive Functions After a Sleep Deprivation Challenge in Healthy Volunteers |
| NCT01903824 | C26401/1111 2013-001883-51 | Ph 1 | completed | Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects |
| NCT01348607 results posted | SCUSF 0803 SCUSF-0803, 5U10CA081920-11 | Ph 2 | terminated | Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy |
| NCT00829322 | Modafinil/lung/09 | Ph 4 | completed | Modafinil for the Treatment of Fatigue in Lung Cancer V9.0 |
| NCT01354470 | CPMC-APRL-8B | Ph 2 | completed | A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence |
| NCT00538655 | 27.004 | Ph 2 | completed | A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence |
| NCT00917748 | DOCET_L_04203 | Ph 3 | completed | Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF) |
| NCT01067222 Harmony1 | P07-03 / BF2.649 2008-007866-46 | Ph 3 | completed | Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy |
| NCT01601730 | H-25669 1RC1DA028387, DPMC | Ph 1 | completed | Modafinil - Escitalopram Study for Cocaine Dependence |
| NCT01440621 ModCRF | ModCRF | Ph 3 | completed | Modafinil in Cancer Related Fatigue |
Showing 50 of 52 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROVIGIL FDA Label Details
Indications & Usage
FDA Label (PDF)PROVIGIL is indicated for the treatment of Narcolepsy; Obstructive Sleep Apnea; Shift Work Disorder.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment