LORAZEPAM INTENSOL (lorazepam)
Lorazepam Intensol is a benzodiazepine indicated for the management of anxiety disorders or for the short-term relief of symptoms of anxiety, including anxiety associated with depressive symptoms. It is generally not indicated for anxiety or tension associated with the stress of everyday life. Because its effectiveness for long-term use (exceeding four months) has not been systematically evaluated, the physician should periodically reassess the drug's usefulness for the individual patient.
How LORAZEPAM INTENSOL Works
Lorazepam is a benzodiazepine that exerts its effects by binding to the benzodiazepine site on the gamma-aminobutyric acid-A (GABA-A) receptor complex in the central nervous system. This binding enhances the inhibitory effect of GABA by increasing the frequency of chloride channel opening. This results in an influx of chloride ions, leading to hyperpolarization of the postsynaptic neuronal membrane and a subsequent reduction in neuronal excitability.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1991-06-28
- Routes
- ORAL
- Dosage Forms
- CONCENTRATE
LORAZEPAM INTENSOL Approval History
What LORAZEPAM INTENSOL Treats
2 indicationsLORAZEPAM INTENSOL is approved for 2 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety Disorder
- Anxiety
LORAZEPAM INTENSOL Boxed 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 PR...
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 ).
LORAZEPAM INTENSOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LORAZEPAM INTENSOL
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05662228 | 22-1992 | Ph 2 | active not recruiting | Therapies for Down Syndrome Regression Disorder |
| NCT01949662 results posted | 2013-0345 NCI-2013-02351, 1R21CA186000-01A1 | Ph 2 | active not recruiting | Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer |
| NCT03743649 | 2018-0706 NCI-2018-02438, 2018-0706 | Ph 2, Ph 3 | active not recruiting | Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care |
| NCT06004115 | 2022-009 R01MH132565 | Ph 4 | recruiting | Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression |
| NCT06799494 | STUDY00008623 | Ph 4 | recruiting | HPV Vaccine Reduced Dose |
| NCT05599126 | 2021-TX-002 | Ph 4 | recruiting | A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems |
| NCT04715230 Meth-OD results posted | M200C-2101 U01DA053043 | Ph 2 | terminated | Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose |
| NCT01441843 results posted | NL3253507810 | Ph 4 | completed | Resistance Under the Microscope |
| NCT03090620 TAAT results posted | 16-1730 | Ph 4 | completed | Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome |
| NCT00624780 results posted | A0081147 | Ph 4 | completed | Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder |
| NCT03021018 results posted | EP0087 | Ph 2 | completed | A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting |
| NCT03756038 results posted | PRO18090064 | Ph 2 | terminated | Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care |
| NCT01889602 results posted | CPDEC | Ph 4 | completed | Characterizing and Predicting Drug Effects on Cognition |
| NCT03788889 PKAT | 18-94 | Ph 4 | withdrawn | Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine |
| NCT01330459 results posted | OHSU FAMPLAN 6734 | Ph 4 | completed | Hydrocodone For Pain Control in First Trimester Surgical Abortion |
| NCT01275144 results posted | 12596 H9P-EW-LNCG | Ph 1 | completed | A Study of the Effect of LY2216684 on Lorazepam |
| NCT02239380 results posted | B3541002 2017-000125-13 | Ph 3 | completed | Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan |
| NCT01870024 LORACLOFT | P110123 2012-003795-39 | Ph 3 | completed | Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus |
| NCT03180632 Endo-Lora | JP2017 | Ph 2 | completed | Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy: |
| NCT02407704 MEDEX results posted | MH090333-04 PRO13110090, MH090333 | Ph 4 | completed | A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise |
| NCT02134366 | EPC-1 | Ph 3 | terminated | Clobazam Use in Epilepsia Partialis Continua - Pilot Study |
| NCT02564029 results posted | B7431005 | Ph 2 | completed | PF-06372865 in Subjects With Photosensitive Epilepsy |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01780519 | 12-006469 | Ph 1 | completed | The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms |
| NCT02147548 | ETILANCE - ETI 175 | Ph 3 | completed | Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly |
| NCT02462109 CINS | HS 1330 | Ph 1 | completed | Catatonia in Nodding Syndrome and Lorazepam Treatment |
| NCT01901003 PremedX | 2011-005171-16 2011-32 | Ph 3 | completed | Sedative Premedication: Efficacy On Patient Experience |
| NCT01994668 | B3541001 | Ph 1 | completed | Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects |
| NCT01827293 | SB-067 | Ph 3 | completed | Promethazine vs. Lorazepam for Treatment of Vertigo |
| NCT00736931 | N01297 | Ph 1 | completed | Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam |
| NCT00720421 | D1140C00003 EudractCT 2008-001757-17 | Ph 1 | completed | A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator. |
| NCT00807937 results posted | D1140C00014 | Ph 2 | completed | Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325 |
| NCT00902772 | D1140C00008 | Ph 1 | completed | Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users |
| NCT00750802 | D0850C00014 Eudract # 2008-001757-17 | Ph 1 | completed | A Sedation/Cognition/EEG Study Using AZD6280 and Comparator |
| NCT00735527 INLOR | INLOR | Ph 3 | completed | Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LORAZEPAM INTENSOL FDA Label Details
Indications & Usage
LORAZEPAM INTENSOL is indicated for the treatment of Anxiety Disorder; Anxiety.
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 patien...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment