Overview
Modafinil is a stimulant drug marketed as a 'wakefulness promoting agent' and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. The prexin neuron activation is associated with psychoactivation and euphoria. The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA.
Indication
To improve wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Fatigue
- Major Depressive Disorder (MDD)
- Narcolepsy
- Obstructive Sleep Apnea (OSA)
- Shift-work related sleep disturbance
Research Report
Modafinil: A Comprehensive Pharmacological and Clinical Review
1. Introduction and Background
1.1. Overview of Modafinil
Modafinil, identified by DrugBank ID DB00745 and CAS Number 68693-11-8, is a centrally acting stimulant classified as a wakefulness-promoting agent [User Query]. Chemically, it is 2-acetamide.[1] As a small molecule drug, it has garnered significant attention for its unique pharmacological profile and therapeutic applications.
1.2. Initial Summary of Use
Modafinil is primarily utilized to improve wakefulness in adult patients experiencing excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD).[3] These conditions are characterized by a pronounced difficulty in maintaining wakefulness, significantly impacting daily functioning and quality of life.
1.3. Historical Context and Development
The development of modafinil traces back to the 1970s in France.[5] It received its first marketing authorization in Europe (France) in June 1992.[5] In the United States, the Food and Drug Administration (FDA) approved modafinil for the treatment of narcolepsy in 1998, subsequently expanding its indications to include OSA and SWD in 2003.[6] Modafinil is marketed under various brand names, with Provigil being one of the most widely recognized.[9]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/02/08 | Not Applicable | UNKNOWN | University of Electronic Science and Technology of China | ||
2018/02/07 | Phase 2 | Completed | |||
2017/06/14 | Phase 3 | Completed | |||
2017/06/09 | Phase 1 | Completed | |||
2017/03/17 | Phase 2 | Completed | |||
2016/09/12 | Phase 2 | Completed | |||
2016/08/05 | Phase 2 | Withdrawn | |||
2016/07/01 | Phase 2 | Completed | |||
2015/11/13 | Phase 1 | Completed | |||
2015/09/02 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-6423 | ORAL | 100 mg in 1 1 | 1/6/2019 | |
| Bryant Ranch Prepack | 63629-4998 | ORAL | 200 mg in 1 1 | 2/11/2021 | |
| Cephalon, LLC | 63459-101 | ORAL | 100 mg in 1 1 | 2/12/2024 | |
| Rebel Distributors Corp | 21695-234 | ORAL | 100 mg in 1 1 | 1/14/2010 | |
| Apotex Corp. | 60505-2527 | ORAL | 200 mg in 1 1 | 12/4/2023 | |
| Bionpharma Inc. | 69452-343 | ORAL | 200 mg in 1 1 | 7/21/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-5121 | ORAL | 100 mg in 1 1 | 2/22/2021 | |
| Major Pharmaceuticals | 0904-6424 | ORAL | 200 mg in 1 1 | 1/6/2019 | |
| Rising Health, LLC | 57237-155 | ORAL | 200 mg in 1 1 | 2/9/2021 | |
| Proficient Rx LP | 71205-544 | ORAL | 200 mg in 1 1 | 6/1/2023 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
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