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]

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Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Modafinil for Wakefulness in the Critical Care Units	2021/02/12	NCT04751227	N/A	Completed	King Faisal Specialist Hospital & Research Center
Treatment for Cognitive Impairment in Depression	2020/03/20	NCT04317001	Phase 3	Withdrawn	Stanford University
Modafinil to Prevent Postoperative Cognitive Decline	2019/04/16	NCT03914118	Phase 2	Completed	The Cooper Health System
Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants	2019/03/27	NCT03893032	Phase 2	UNKNOWN	United States Army Aeromedical Research Laboratory
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors	2019/03/06	NCT03864042	Phase 1	Active, not recruiting	Pfizer
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia	2018/12/11	NCT03772314	Phase 2	Completed	Emory University
Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue	2018/08/08	NCT03621761	Phase 4	Completed	University of Michigan
Modafinil's Effects on Cognition in Remitted MDD	2018/08/08	NCT03620253	Phase 3	Terminated	Unity Health Toronto
Modafinil Effects on EEG Biomarkers of Reward and Motivation	2018/08/06	NCT03616717	Phase 4	Completed	University of California, San Diego
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults	2018/05/11	NCT03522506	Phase 1	Completed	Takeda

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Modafinil	Alembic Pharmaceuticals Limited	46708-386	ORAL	200 mg in 1 1	6/3/2022
Modafinil	CIMA LABS INC.	55253-802	ORAL	200 mg in 1 1	2/12/2024
Modafinil	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-605	ORAL	200 mg in 1 1	2/20/2024
Modafinil	Aphena Pharma Solutions - Tennessee, LLC	71610-685	ORAL	200 mg in 1 1	1/12/2023
Modafinil	Alembic Pharmaceuticals Inc.	62332-385	ORAL	100 mg in 1 1	10/1/2021
Modafinil	OrchidPharma Inc	42043-161	ORAL	200 mg in 1 1	1/13/2022
Modafinil	Zydus Lifesciences Limited	70771-1052	ORAL	200 mg in 1 1	10/4/2023
Modafinil	American Health Packaging	68084-721	ORAL	200 mg in 1 1	12/12/2023
Modafinil	Aurobindo Pharma Limited	65862-601	ORAL	100 mg in 1 1	2/11/2021
Modafinil	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	Southern Cross Pharma Pty Ltd	Medicine	A	4/4/2017
MODAFIN modafinil 100mg tablet blister pack	230327	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/20/2015
MODAFINIL SPR modafinil 100 mg tablets blister pack	276420	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/20/2017
MODAFINIL ARW modafinil 100 mg tablets blister pack	276421	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/20/2017
MOFINIL modafinil 100mg tablet blister pack	282365	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/15/2017
MODAFINIL-RJIC modafinil 100 mg tablet blister pack	423910	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/28/2023
MODAVIGIL modafinil 100mg tablet blister pack	168497	Teva Pharma Australia Pty Ltd	Medicine	A	5/21/2010
MVIGIL modafinil 100mg tablet blister pack	282361	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/15/2017
MFINIL modafinil 100mg tablet blister pack	282363	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/15/2017
APO-MODAFINIL modafinil 100 mg tablet blister pack	395230	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/19/2022

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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