Lorazepam
Regulatory sources consulted
- openfda-label-22212bf6-1414-4b32-bc67-25d614c357ee
- aemps-cima-ft-68477
- ansm-bdpm-rcp-67917629
- Clinical Pharmacist Knowledge
- OpenFDA · N05BA06
- RxNorm rxcui 6470 ↗
Approved indications
- Management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Effectiveness in long-term use (>4 months) has not been assessed.
Contraindications
Absolute
- Hypersensitivity to benzodiazepines or to any components of the formulation.
- Acute narrow-angle glaucoma.
- Severe respiratory insufficiency.
- Sleep apnea syndrome.
- Severe hepatic insufficiency.
- Myasthenia gravis.
Clinical warnings
- Boxed warning · RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS. Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death. The use of benzodiazepines exposes users to risks of abuse, misuse, and addiction. Continued use may lead to physical dependence and abrupt discontinuation may precipitate life-threatening withdrawal reactions. — FDA
Drug interactions
- HighOpioidsN02A
Mechanism: Additive CNS depression at different receptor sites (GABA-A for benzodiazepines, mu for opioids), resulting in profound sedation and respiratory depression.
Recommendation: Reserve concomitant use for patients with no alternative options. Use the lowest effective doses and minimum duration. Closely monitor for sedation and respiratory depression.
FDA label
- ModerateValproateN03AG01
Mechanism: Inhibition of lorazepam glucuronidation, resulting in increased plasma concentrations and reduced clearance.
Recommendation: Reduce lorazepam dosage by approximately 50% when coadministered with valproate.
FDA label
- HighClozapineN05AH02
Mechanism: Pharmacodynamic, not fully elucidated. May produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.
Recommendation: Monitor closely for profound sedation, hypotension, and respiratory/cardiac arrest. Some clinicians recommend avoiding the combination.
FDA labelANSM RCP
Adverse events
Common (≥1%)
sedation · dizziness · weakness · unsteadiness
Rare but serious
respiratory depression · withdrawal reactions · seizures · agranulocytosis · anaphylactoid reactions · cardiac arrest
Pregnancy and lactation
Use during late pregnancy may cause neonatal sedation and/or withdrawal syndrome. Observational data do not show a clear association with major birth defects. Generally should be avoided during pregnancy. Excreted in human milk; breastfeeding is not recommended.