Armodafinil

Overview

Armodafinil is the enantiopure of the wakefulness-promoting agent modafinil (Provigil), and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Research has shown that armodafinil significantly improves driving simulator performance in patients with SWD. Armodafinil consists of the (−)-R-enantiomer of the racemic modafinil. Armodafinil is produced by the pharmaceutical company Cephalon Inc. (a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.) and was approved by the U.S. Food and Drug Administration (FDA) in June 2007.

Indication

用于改善与阻塞性睡眠呼吸暂停（OSA）、发作性睡病或轮班工作障碍（SWD）相关的过度嗜睡的成年患者的清醒度。亦可用于治疗注意缺陷多动障碍、慢性疲劳综合征和重度抑郁症。

Associated Conditions

Narcolepsy
Shift-work related sleep disturbance
Somnolence

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia	2015/09/17	NCT02552303	Not Applicable	Completed	University of Pennsylvania
Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients	2015/06/23	NCT02478580	Phase 3	Completed	University of Texas Southwestern Medical Center
Effect of Armodafinil on Simulated Driving	2015/06/11	NCT02468856	Phase 1	Completed	University of Florida
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia	2014/05/30	NCT02151253	Phase 2	Completed	Duke University
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke	2013/07/11	NCT01896128	Phase 2	Completed	Burke Rehabilitation Hospital
Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma	2013/02/01	NCT01781468	Phase 3	Completed	Alliance for Clinical Trials in Oncology
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer	2012/12/10	NCT01746043	Phase 2	Completed	M.D. Anderson Cancer Center
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy	2012/06/20	NCT01624480	Phase 1	Completed	Teva Branded Pharmaceutical Products R&D, Inc.
Armodafinil for Patients Starting Hepatitis C Virus Treatment	2011/11/11	NCT01470651	Phase 4	Terminated	Research Foundation for Mental Hygiene, Inc.
Effect of Nuvigil on Fatigue	2011/10/27	NCT01460628	Phase 4	Completed	Massachusetts General Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Armodafinil	Preferred Pharmaceuticals Inc.	68788-7593	ORAL	250 mg in 1 1	2/15/2024
Armodafinil	Teva Pharmaceuticals USA, Inc.	0093-3093	ORAL	200 mg in 1 1	5/30/2023
Armodafinil	Mylan Pharmaceuticals Inc.	0378-3431	ORAL	50 mg in 1 1	9/17/2018
Armodafinil	Aurobindo Pharma Limited	65862-807	ORAL	250 mg in 1 1	2/2/2024
Armodafinil	Bryant Ranch Prepack	71335-1308	ORAL	250 mg in 1 1	5/22/2018
Armodafinil	Aurobindo Pharma Limited	65862-998	ORAL	200 mg in 1 1	2/2/2024
Armodafinil	Sandoz Inc	0781-8037	ORAL	150 mg in 1 1	1/18/2023
Armodafinil	Quality Care Products LLC	55700-510	ORAL	250 mg in 1 1	8/29/2019
Nuvigil	Cephalon, LLC	63459-205	ORAL	50 mg in 1 1	5/26/2023
ARMODAFINIL	DirectRx	72189-353	ORAL	200 mg in 1 1	5/19/2022

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.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ARMODAFINIL-TEVA armodafinil 50 mg tablet blister pack	404160	Teva Pharma Australia Pty Ltd	Medicine	A	5/24/2023
NUVIGIL armodafinil 150 mg tablet blister pack	226559	Teva Pharma Australia Pty Ltd	Medicine	A	11/26/2015
NUVIGIL armodafinil 50 mg tablet blister pack	272052	Teva Pharma Australia Pty Ltd	Medicine	A	4/28/2016
ARMODAFINIL-TEVA armodafinil 150 mg tablet blister pack	404161	Teva Pharma Australia Pty Ltd	Medicine	A	5/24/2023
NUVIGIL armodafinil 250 mg tablet blister pack	226558	Teva Pharma Australia Pty Ltd	Medicine	A	11/26/2015
ARMODAFINIL-TEVA armodafinil 250 mg tablet blister pack	404162	Teva Pharma Australia Pty Ltd	Medicine	A	5/24/2023

Health Canada Drug Approvals

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

CIMA AEMPS Drug Approvals

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

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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