Overview
Suvorexant is a selective dual antagonist of orexin receptors OX1R and OX2R that promotes sleep by reducing wakefulness and arousal. It has been approved for the treatment of insomnia.
Background
Suvorexant is a selective dual antagonist of orexin receptors OX1R and OX2R that promotes sleep by reducing wakefulness and arousal. It has been approved for the treatment of insomnia.
Indication
Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/03 | Phase 2 | Not yet recruiting | Marianne Goodman | ||
2025/02/19 | Phase 4 | Withdrawn | |||
2025/01/23 | Phase 4 | Not yet recruiting | |||
2024/11/07 | Phase 2 | Not yet recruiting | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | ||
2024/10/24 | Phase 3 | Not yet recruiting | |||
2024/09/05 | Phase 4 | Recruiting | |||
2024/07/03 | Phase 1 | Recruiting | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||
2024/03/22 | Early Phase 1 | Recruiting | |||
2023/12/08 | Phase 4 | Not yet recruiting | |||
2023/06/18 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Merck Sharp & Dohme LLC | 0006-0005 | ORAL | 5 mg in 1 1 | 2/28/2023 | |
| Merck Sharp & Dohme LLC | 0006-0033 | ORAL | 10 mg in 1 1 | 2/28/2023 | |
| Merck Sharp & Dohme LLC | 0006-0325 | ORAL | 15 mg in 1 1 | 2/28/2023 | |
| Merck Sharp & Dohme LLC | 0006-0335 | ORAL | 20 mg in 1 1 | 2/28/2023 |
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 |
|---|---|---|---|---|---|
| BELSOMRA suvorexant 15mg tablet blister pack | 207709 | Medicine | A | 11/16/2016 | |
| BELSOMRA suvorexant 20mg tablet blister pack | 207712 | Medicine | A | 11/16/2016 |