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Ativan (lorazepam)
Lorazepam (Ativan) is an intermediate-acting benzodiazepine approved in 1977. IV form is first-line for status epilepticus. No active metabolites make it safer in elderly/liver disease. Available generically. Schedule IV controlled substance.
At a glance
| Generic name | lorazepam |
|---|---|
| Also known as | Ativan |
| Sponsor | Generic (originally Wyeth/Pfizer) |
| Drug class | Benzodiazepine [EPC] |
| Target | GABA-A receptor alpha-1/beta-3/gamma-2, Fatty acid-binding protein, liver |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1977-09-30 (United States) |
Approved indications
- Absence seizure
- Anxiety
- Atonic seizure
- Induce Anterograde Amnesia
- Lennox-Gastaut syndrome
- Myoclonic seizure
- Panic disorder
- Sedation as Adjunct to Anesthesia
- Status epilepticus
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
Serious adverse events
- Respiratory depression
- Apnea
- Seizures
- Coma
- Anaphylacticoid reactions
- Agranulocytosis
- Pancytopenia
- Suicidal ideation/attempt
- Hepatotoxicity (jaundice, increase in bilirubin, increase in liver transaminases)
- Worsening of sleep apnea
Key clinical trials
- Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy: a Randomized Double Blinded Study (Phase 2)
- A Randomized, Double-Blind, Single-Dose Study to Assess the Pharmacodynamic Effects of SM-1 Versus Comparator and Placebo in a 5 Hour Phase Advance Model of Insomnia in Adults Who Suffer From Short-Te (Phase 2)
- A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation (Phase 4)
- Individualized Computational Assessment of the Effects of GABA Receptor Modulation in Posttraumatic Stress Disorder (Phase 4)
- Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression (Phase 4)
- Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test (NA)
- Comparisons Between Virtual Reality and Hypno-Virtual Reality for Procedural Pain and Anxiety During a Diagnostic Hysteroscopy: A Pilot Randomized Controlled Trial (NA)
- A Window Trial of 5-Azacytidine or Nivolumab or Combination Nivolumab Plus 5-Azacytidine in Resectable HPV-Associated Head and Neck Squamous Cell Cancer (Phase 2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8999393 | 2034-01-08 | Formulation |
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 |
| FDA Orange Book | Patents + exclusivity |