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.
Background
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 |
|---|---|---|---|---|---|
2020/03/20 | Phase 3 | Withdrawn | |||
2019/04/16 | Phase 2 | Completed | |||
2019/03/27 | Phase 2 | UNKNOWN | United States Army Aeromedical Research Laboratory | ||
2019/03/06 | Phase 1 | Active, not recruiting | |||
2018/12/11 | Phase 2 | Completed | |||
2018/08/08 | Phase 4 | Completed | |||
2018/08/08 | Phase 3 | Terminated | |||
2018/08/06 | Phase 4 | Completed | |||
2018/05/11 | Phase 1 | Completed | |||
2018/03/19 | Phase 1 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Limited | 46708-386 | ORAL | 200 mg in 1 1 | 6/3/2022 | |
| CIMA LABS INC. | 55253-802 | ORAL | 200 mg in 1 1 | 2/12/2024 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-605 | ORAL | 200 mg in 1 1 | 2/20/2024 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-685 | ORAL | 200 mg in 1 1 | 1/12/2023 | |
| Alembic Pharmaceuticals Inc. | 62332-385 | ORAL | 100 mg in 1 1 | 10/1/2021 | |
| OrchidPharma Inc | 42043-161 | ORAL | 200 mg in 1 1 | 1/13/2022 | |
| Zydus Lifesciences Limited | 70771-1052 | ORAL | 200 mg in 1 1 | 10/4/2023 | |
| American Health Packaging | 68084-721 | ORAL | 200 mg in 1 1 | 12/12/2023 | |
| Aurobindo Pharma Limited | 65862-601 | ORAL | 100 mg in 1 1 | 2/11/2021 | |
| Viona Pharmaceuticals Inc | 72578-005 | ORAL | 100 mg in 1 1 | 11/10/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| MODAFINIL SANDOZ modafinil 100 mg tablets blister pack | 269914 | Medicine | A | 4/4/2017 | |
| MODAFIN modafinil 100mg tablet blister pack | 230327 | Medicine | A | 11/20/2015 | |
| MODAFINIL SPR modafinil 100 mg tablets blister pack | 276420 | Medicine | A | 3/20/2017 | |
| MODAFINIL ARW modafinil 100 mg tablets blister pack | 276421 | Medicine | A | 3/20/2017 | |
| MOFINIL modafinil 100mg tablet blister pack | 282365 | Medicine | A | 11/15/2017 | |
| MODAFINIL-RJIC modafinil 100 mg tablet blister pack | 423910 | Medicine | A | 11/28/2023 | |
| MODAVIGIL modafinil 100mg tablet blister pack | 168497 | Medicine | A | 5/21/2010 | |
| MVIGIL modafinil 100mg tablet blister pack | 282361 | Medicine | A | 11/15/2017 | |
| MFINIL modafinil 100mg tablet blister pack | 282363 | Medicine | A | 11/15/2017 | |
| APO-MODAFINIL modafinil 100 mg tablet blister pack | 395230 | Medicine | A | 9/19/2022 |