Overview
A short-acting barbiturate that is effective as a sedative and hypnotic (but not as an anti-anxiety) agent and is usually given orally. It is prescribed more frequently for sleep induction than for sedation but, like similar agents, may lose its effectiveness by the second week of continued administration. (From AMA Drug Evaluations Annual, 1994, p236)
Background
A short-acting barbiturate that is effective as a sedative and hypnotic (but not as an anti-anxiety) agent and is usually given orally. It is prescribed more frequently for sleep induction than for sedation but, like similar agents, may lose its effectiveness by the second week of continued administration. (From AMA Drug Evaluations Annual, 1994, p236)
Indication
For the short-term treatment of insomnia.
Associated Conditions
- Convulsions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/09/26 | Phase 1 | Completed | |||
2009/04/08 | Not Applicable | Withdrawn | |||
2008/02/25 | Phase 3 | Terminated | Hospital Universitari Son Dureta | ||
2005/07/25 | Phase 1 | Withdrawn | |||
2003/04/16 | Phase 1 | Completed | Orphan Medical |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sagent Pharmaceuticals | 25021-676 | INTRAVENOUS, INTRAMUSCULAR | 50 mg in 1 mL | 4/18/2017 | |
| Akorn | 17478-181 | INTRAMUSCULAR, INTRAVENOUS | 50 mg in 1 mL | 2/1/2024 | |
| Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals) | 24201-010 | INTRAMUSCULAR, INTRAVENOUS | 50 mg in 1 mL | 1/10/2023 | |
| Akron | 76478-501 | INTRAVENOUS, INTRAMUSCULAR | 50 mg in 1 mL | 2/1/2024 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||