Diazepam (Diazepam Elixir)
What to know about Diazepam — also sold as Diazepam Elixir, APX-Diazepam, DIAZEPAM-WGR, Antenex 2, Valpam 2 and 3 more: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
Diazepam (brand names: Diazepam Elixir, APX-Diazepam, DIAZEPAM-WGR, Antenex 2, Valpam 2 and 3 more) is classified as Moderate risk (3 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Long-acting benzodiazepine with significant CNS depression and dependency potential.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Moderate (3 points)
- CNS depressant: May cause sedation, impair driving, and affect work capacity
- Respiratory depression risk: Requires monitoring, especially with other CNS depressants
- Recommended maximum duration: 28 days
- SIRA reportable: Flagged for NSW workers compensation reporting
- PBS listed: Subsidised under the Australian Pharmaceutical Benefits Scheme
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Long-acting benzodiazepine with significant CNS depression and dependency potential.
How Diazepam is regulated
Diazepam is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Work capacity impact: As a CNS depressant, Diazepam may impair driving, operating machinery, and cognitive function. Work capacity certificates should reflect any medication-related restrictions.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
Listed on the Pharmaceutical Benefits Scheme (PBS) for subsidised prescribing.
Flagged as reportable under SIRA guidelines in NSW. Claims involving this medication may require additional reporting and clinical justification.
All Australian workers compensation schemes flag benzodiazepine use as high-risk, particularly when combined with opioids. Duration should be limited and tapering plans documented.
United Kingdom NICE / MHRA / FPM
UK drug driving laws (Section 5A Road Traffic Act 2006) set specific limits for prescription drugs that cause impairment. Employers and occupational health advisors should assess fitness to work.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: 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 ) .
The CDC and FDA have issued joint warnings about the risks of concurrent benzodiazepine and opioid use. Workers compensation adjusters should flag this combination for clinical review.
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.