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LORAZEPAM
LORAZEPAM is a Benzodiazepine [EPC] drug. It is currently FDA-approved (first approved 1977).
At a glance
| Generic name | LORAZEPAM |
|---|---|
| Drug class | Benzodiazepine [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1977 |
Approved indications
Boxed warnings
- WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). • The use of benzodiazepines, including lorazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). • The continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage ( DOSAGE AND ADMINISTRATION and WARNINGS ).
Common side effects
- Sedation
- Dizziness
- Weakness
- Unsteadiness
- Fatigue
- Drowsiness
- Amnesia
- Memory impairment
- Confusion
- Disorientation
- Depression
- Headache
Serious adverse events
- Respiratory depression
- Apnea
- Suicidal ideation/attempt
- Convulsions/seizures
- Coma
- Anaphylacticoid reactions
- Agranulocytosis
- Pancytopenia
- Hallucinations
- Worsening of sleep apnea
Key clinical trials
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Therapies for Down Syndrome Regression Disorder (PHASE2)
- Lorazepam for Delirium Prevention in Critically Ill Patients With High Anttila-Index (PHASE4)
- Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer (PHASE2)
- Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (PHASE2)
- 5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC (PHASE2)
- Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care (PHASE2, PHASE3)
- Blood Concentration in Lorazepam and Treatment in Adult Catatonia
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LORAZEPAM CI brief — competitive landscape report
- LORAZEPAM updates RSS · CI watch RSS
Frequently asked questions about LORAZEPAM
What is LORAZEPAM?
LORAZEPAM is a Benzodiazepine [EPC] drug.
What drug class is LORAZEPAM in?
LORAZEPAM belongs to the Benzodiazepine [EPC] class. See all Benzodiazepine [EPC] drugs at /class/benzodiazepine-epc.
When was LORAZEPAM approved?
LORAZEPAM was first approved on 1977.
What development phase is LORAZEPAM in?
LORAZEPAM is FDA-approved (marketed).
What are the side effects of LORAZEPAM?
Common side effects of LORAZEPAM include Sedation, Dizziness, Weakness, Unsteadiness, Fatigue, Drowsiness. Serious adverse events: Respiratory depression, Apnea, Suicidal ideation/attempt, Convulsions/seizures.
Related
- Drug class: All Benzodiazepine [EPC] drugs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing