Last reviewed · How we verify
DIAZEPAM
DIAZEPAM is a Benzodiazepine [EPC] drug. It is currently FDA-approved (first approved 1963).
Diazepam is a small molecule that acts as a positive allosteric modulator of the GABA-A receptor, an anion channel. It has been studied in various clinical trials for conditions such as labor pain, non-Hodgkin's lymphoma, and type 1 diabetes mellitus, among others.
At a glance
| Generic name | DIAZEPAM |
|---|---|
| Drug class | Benzodiazepine [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1963 |
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 in 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 diazepam tablets, 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 diazepam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ) . • The continued use of benzodiazepines, including diazepam tablets, 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 diazepam tablets 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 diazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ) .
Common side effects
- drowsiness
- fatigue
- muscle weakness
- ataxia
- confusion
- depression
- dysarthria
- headache
- slurred speech
- tremor
- vertigo
- constipation
Key clinical trials
- TEAS for Sedation During ERCP: A Multicenter Trial (NA)
- Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care (PHASE4)
- Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (PHASE2, PHASE3)
- H01 in Adults With Interstitial Lung Disease (The SOLIS Study) (PHASE2)
- A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants (PHASE1)
- Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy
- Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (PHASE2)
- Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia (PHASE2)
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:
- DIAZEPAM CI brief — competitive landscape report
- DIAZEPAM updates RSS · CI watch RSS
Frequently asked questions about DIAZEPAM
What is DIAZEPAM?
DIAZEPAM is a Benzodiazepine [EPC] drug.
What drug class is DIAZEPAM in?
DIAZEPAM belongs to the Benzodiazepine [EPC] class. See all Benzodiazepine [EPC] drugs at /class/benzodiazepine-epc.
When was DIAZEPAM approved?
DIAZEPAM was first approved on 1963.
What development phase is DIAZEPAM in?
DIAZEPAM is FDA-approved (marketed).
What are the side effects of DIAZEPAM?
Common side effects of DIAZEPAM include drowsiness, fatigue, muscle weakness, ataxia, confusion, depression.
Related
- Drug class: All Benzodiazepine [EPC] drugs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing