MedPath

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.

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

Published: Jun 5, 2025

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]

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
CIMA LABS INC.
55253-801
ORAL
100 mg in 1 1
2/12/2024
Cephalon, LLC
63459-201
ORAL
200 mg in 1 1
2/12/2024
Aphena Pharma Solutions - Tennessee, LLC
43353-956
ORAL
200 mg in 1 1
7/18/2014
Bryant Ranch Prepack
71335-1122
ORAL
100 mg in 1 1
4/6/2023
Quality Care Products, LLC
55700-695
ORAL
200 mg in 1 1
11/20/2018
Alembic Pharmaceuticals Limited
46708-385
ORAL
100 mg in 1 1
6/3/2022
AvPAK
50268-570
ORAL
100 mg in 1 1
6/2/2022
Apotex Corp.
60505-2526
ORAL
100 mg in 1 1
12/4/2023
STAT Rx USA LLC
42549-678
ORAL
200 mg in 1 1
5/14/2012
A-S Medication Solutions
50090-3865
ORAL
100 mg in 1 1
12/31/2016

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TEVA-MODAFINIL
teva canada limited
02420260
Tablet - Oral
100 MG
7/2/2014
JAMP MODAFINIL
02503727
Tablet - Oral
100 MG
3/11/2021
MAR-MODAFINIL
marcan pharmaceuticals inc
02432560
Tablet - Oral
100 MG
1/9/2015
BIO-MODAFINIL
biomed pharma
02442078
Tablet - Oral
100 MG
10/6/2015
AURO-MODAFINIL
auro pharma inc
02430487
Tablet - Oral
100 MG
10/24/2014
MODAFINIL TABLETS
Strides Pharma Canada Inc
02479303
Tablet - Oral
100 MG
N/A
MODAFINIL
sanis health inc
02530244
Tablet - Oral
100 MG
12/19/2022
IPG-MODAFINIL
marcan pharmaceuticals inc
02432013
Tablet - Oral
100 MG
N/A
ALERTEC
teva canada limited
02239665
Tablet - Oral
100 MG
3/24/1999
APO-MODAFINIL
02285398
Tablet - Oral
100 MG
5/1/2008

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
MODAFINILO ARISTO 100 MG COMPRIMIDOS EFG
84141
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MODAFINILO BLUEFISH 100 mg COMPRIMIDOS EFG
Bluefish Pharmaceuticals Ab (Publ)
80643
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MODAFINILO TARBIS 100 mg COMPRIMIDOS EFG
Tarbis Farma S.L.
80929
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MODIODAL 100 mg COMPRIMIDOS
61540
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MODAFINILO VIATRIS 100 MG COMPRIMIDOS EFG
83641
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MODAFINILO AUROVITAS 100 MG COMPRIMIDOS EFG
Aurovitas Spain, S.A.U.
75919
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MODAFINILO MYLAN 100 mg COMPRIMIDOS EFG
Mylan Pharmaceuticals S.L.
72187
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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