Modafinil
- Generic Name
- Modafinil
- Brand Names
- Provigil
- Drug Type
- Small Molecule
- Chemical Formula
- C15H15NO2S
- CAS Number
- 68693-11-8
- Unique Ingredient Identifier
- R3UK8X3U3D
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/30 | Phase 1 | Completed | |||
2024/09/30 | Phase 1 | Completed | |||
2024/09/12 | Phase 2 | Recruiting | Clinical Academic Center (2CA-Braga) | ||
2024/05/08 | Phase 2 | Recruiting | |||
2024/05/08 | Phase 2 | Recruiting | |||
2024/04/09 | Phase 3 | Not yet recruiting | |||
2023/09/18 | Phase 4 | Recruiting | |||
2023/01/09 | Early Phase 1 | Not yet recruiting | |||
2022/04/18 | Phase 3 | Not yet recruiting | |||
2021/02/12 | N/A | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
Modafinil | ORAL | 100 mg in 1 1 | 2021/10/01 | 62332-385 | |
Modafinil | ORAL | 200 mg in 1 1 | 2021/02/11 | 63629-4998 | |
Modafinil | ORAL | 100 mg in 1 1 | 2023/10/04 | 70771-1051 | |
Provigil | ORAL | 200 mg in 1 1 | 2024/02/12 | 63459-201 | |
Modafinil | ORAL | 200 mg in 1 1 | 2021/02/11 | 63629-7315 | |
Modafinil | ORAL | 200 mg in 1 1 | 2019/05/03 | 0904-6792 | |
Modafinil | ORAL | 200 mg in 1 1 | 2023/06/01 | 71205-544 | |
Modafinil | ORAL | 200 mg in 1 1 | 2021/10/01 | 71335-1096 | |
Modafinil | ORAL | 100 mg in 1 1 | 2019/05/03 | 0904-6791 | |
Modafinil | ORAL | 100 mg in 1 1 | 2023/01/01 | 71205-477 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|
No Singapore products found
No Singapore products found for this drug
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
Modafinil Capsule | 国药准字H20170013 | 胶囊剂 | N/A | 100mg | Chemical Drug | Approved | 2022/07/15 | Domestic | |
Modafinil Capsule | 国药准字H20170014 | 胶囊剂 | N/A | 200mg | Chemical Drug | Approved | 2022/07/15 | Domestic |
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
MODAGIL modafinil 100mg tablet blister pack | 282359 | Active | 2017/11/15 | modafinil | |
MODAFINIL VIATRIS modafinil 100 mg tablet blister pack | 395231 | Helix Pharmaceuticals Pty Ltd | Active | 2022/09/19 | modafinil |
MODAFINIL-WGR modafinil 100 mg tablet blister pack | 423902 | GM Pharma International Pty Ltd | Active | 2023/11/28 | modafinil |
MODAFINIL GXP modafinil 100mg tablet blister pack | 282362 | Active | 2017/11/15 | modafinil | |
MODAFINIL GPPL modafinil 100mg tablet blister pack | 282364 | Active | 2017/11/15 | modafinil | |
MODAFINIL GH modafinil 100 mg tablet blister pack | 311683 | Southern Cross Pharma Pty Ltd | Active | 2019/01/24 | modafinil |
MODANIL modafinil 100mg tablet blister pack | 282360 | Active | 2017/11/15 | modafinil | |
MODAFINIL MYLAN modafinil 100 mg tablets blister pack | 269913 | Southern Cross Pharma Pty Ltd | Active | 2017/04/04 | modafinil |
MODAFINIL SCP modafinil 100 mg tablets blister pack | 269915 | Southern Cross Pharma Pty Ltd | Active | 2017/04/04 | modafinil |
MODAFINIL-TEVA modafinil 100mg tablet blister pack | 267426 | Teva Pharma Australia Pty Ltd | Active | 2017/07/18 | modafinil |