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 |
|---|---|---|---|---|---|
2015/09/17 | Not Applicable | Completed | |||
2015/06/23 | Phase 3 | Completed | |||
2015/06/11 | Phase 1 | Completed | |||
2014/05/30 | Phase 2 | Completed | |||
2013/07/11 | Phase 2 | Completed | |||
2013/02/01 | Phase 3 | Completed | |||
2012/12/10 | Phase 2 | Completed | |||
2012/06/20 | Phase 1 | Completed | |||
2011/11/11 | Phase 4 | Terminated | |||
2011/10/27 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 68788-7593 | ORAL | 250 mg in 1 1 | 2/15/2024 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3093 | ORAL | 200 mg in 1 1 | 5/30/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-3431 | ORAL | 50 mg in 1 1 | 9/17/2018 | |
| Aurobindo Pharma Limited | 65862-807 | ORAL | 250 mg in 1 1 | 2/2/2024 | |
| Bryant Ranch Prepack | 71335-1308 | ORAL | 250 mg in 1 1 | 5/22/2018 | |
| Aurobindo Pharma Limited | 65862-998 | ORAL | 200 mg in 1 1 | 2/2/2024 | |
| Sandoz Inc | 0781-8037 | ORAL | 150 mg in 1 1 | 1/18/2023 | |
| Quality Care Products LLC | 55700-510 | ORAL | 250 mg in 1 1 | 8/29/2019 | |
| Cephalon, LLC | 63459-205 | ORAL | 50 mg in 1 1 | 5/26/2023 | |
| 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 | Medicine | A | 5/24/2023 | |
| NUVIGIL armodafinil 150 mg tablet blister pack | 226559 | Medicine | A | 11/26/2015 | |
| NUVIGIL armodafinil 50 mg tablet blister pack | 272052 | Medicine | A | 4/28/2016 | |
| ARMODAFINIL-TEVA armodafinil 150 mg tablet blister pack | 404161 | Medicine | A | 5/24/2023 | |
| NUVIGIL armodafinil 250 mg tablet blister pack | 226558 | Medicine | A | 11/26/2015 | |
| ARMODAFINIL-TEVA armodafinil 250 mg tablet blister pack | 404162 | Medicine | A | 5/24/2023 |
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