Product Overview
Generic Name: Diazepam
Brand Names: Valium® (Roche), Diastat® (rectal gel), Valtoco® (nasal spray), various generics
DEA Schedule: C-IV (Schedule IV Controlled Substance) [citation:3][citation:6]
Drug Class: Benzodiazepine, Benzodiazepine Anticonvulsant [citation:3]
Pregnancy Category: D – Positive evidence of human fetal risk [citation:3][citation:6]
Diazepam is a long-acting benzodiazepine with anxiolytic, anticonvulsant, sedative, muscle relaxant, and amnestic properties. It was first synthesized by Roche and approved by the FDA in 1963, becoming one of the most prescribed medications in the world during the 1970s.
Common 10mg Tablet Imprints & Manufacturers
The following list includes **genuine, FDA-approved** 10mg diazepam tablets based on official registrations. Always verify using the NDC (National Drug Code) or consult a pharmacist.
| Imprint/Score | Manufacturer | Color/Shape | NDC (Last 4-5 digits) |
|---|---|---|---|
| ROCHE / ROCHE / VALIUM 10 [citation:6] | Roche Laboratories (Brand) | Blue / Round / 9mm | 00140-0006 |
| 3927 / TEVA [citation:2] | Teva Pharmaceuticals USA | Blue / Round / 8mm | 0172-3927 |
| Z 3927 10 [citation:5][citation:9] | Ivax Pharmaceuticals (Teva) | Blue / Round / 8mm | 00172-3927 |
| D 10 [citation:3] | Aurobindo Pharma | Blue / Round | 59651-0654 |
| C | DC (with score line) [citation:1] | Actavis UK (Historical) | Blue / Round / Beveled edge | Discontinued in UK |
⚠️ Important Warning on “Actavis” 10mg Diazepam
Actavis discontinued manufacturing diazepam 10mg tablets in the UK years ago [citation:1]. Nearly all “Actavis” blue 10mg diazepam currently found on the street or illicit market are counterfeit. Laboratory analyses have shown these often contain Etizolam, Flubromazolam, Bromazolam, or other unapproved research chemical benzodiazepines rather than genuine diazepam [citation:1]. These novel benzodiazepines have different half-lives and toxicity profiles, leading to an increased risk of overdose, amnesia, and unexpected sedation.
Indications and Usage
Diazepam is indicated for [citation:3]:
- Anxiety Disorders: Management of generalized anxiety disorder (GAD)
- Acute Alcohol Withdrawal: Relief of agitation, tremor, and impending delirium tremens
- Muscle Spasms: Adjunct for relief of skeletal muscle spasm due to local trauma or cerebral palsy
- Seizure Disorders: Adjunct in the management of certain seizure disorders
- Pre-procedural Sedation: Premedication for endoscopy or radiology procedures
Mechanism of Action
Diazepam acts as a positive allosteric modulator of the GABA-A receptor. By binding to specific benzodiazepine receptors, it enhances the affinity of gamma-aminobutyric acid (GABA) for its receptor, increasing chloride channel opening frequency. This leads to hyperpolarization of neurons and a reduction in central nervous system excitability, producing anxiolytic, sedative, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
| Parameter | Information |
|---|---|
| Onset of action (oral) | 30-60 minutes |
| Peak plasma concentration | 1-1.5 hours |
| Duration of action (single dose) | 6-12 hours (primary effects) |
| Elimination half-life | 20-80 hours (mean ~48 hours) |
| Active metabolite (desmethyldiazepam) | Half-life 50-120 hours |
Dosage and Administration
Usual Adult Doses (Educational Reference):
- Anxiety (Moderate symptoms): 2-5 mg, 2-4 times daily
- Anxiety (Severe symptoms): 5-10 mg, 3-4 times daily
- Alcohol Withdrawal: 10 mg, 3-4 times during first 24 hours, tapered thereafter
- Muscle Spasm: 2-10 mg, 3-4 times daily
Prescribing Notes:
- Treatment should be as short as possible (usually 2-4 weeks for anxiety, up to 4 weeks for insomnia). Longer-term use requires specialist evaluation.
- Abrupt discontinuation should be avoided. Taper dosage gradually under medical supervision.
Contraindications
- Known hypersensitivity to diazepam or other benzodiazepines
- Myasthenia gravis
- Severe respiratory insufficiency (e.g., COPD exacerbation, sleep apnea)
- Severe hepatic impairment
- Narrow-angle glaucoma (acute angle-closure glaucoma; open-angle glaucoma may be treated with concurrent therapy)
Warnings and Precautions
⚠️ Risks of Concomitant Use with Opioids
Benzodiazepines, including diazepam, are often abused in combination with prescription opioids. This combination increases the risk of profound sedation, respiratory depression, coma, and death [citation:3]. Reserve concomitant prescribing for patients with no alternative treatment options and use the lowest effective doses for the shortest possible duration.
- Dependence and Withdrawal: Physical dependence can occur with prolonged use. Abrupt discontinuation or rapid dose reduction can cause acute withdrawal reactions, including seizures and death.
- Abuse and Addiction: Careful risk assessment is required before prescribing. Monitor for signs of diversion or misuse.
- Neonatal Sedation and Withdrawal: Use during pregnancy, especially in the third trimester, can cause neonatal sedation (floppy baby syndrome) and withdrawal symptoms lasting weeks.
Adverse Reactions (Side Effects)
Most Common (≥1%):
- Drowsiness, fatigue, sedation (“hangover” effect next day)
- Muscle weakness, ataxia (impaired coordination)
- Slurred speech (dysarthria)
- Dizziness, lightheadedness
- Blurred vision
Serious Adverse Reactions (Rare):
- Respiratory Depression: Particularly when co-administered with opioids or alcohol
- Anterograde Amnesia: Impaired formation of new memories
- Paradoxical Reactions: Agitation, aggression, hostility, rage, hallucinations — more common in children and elderly
- Blood dyscrasias and jaundice
Drug Interactions
| Drug Class | Interaction Effect |
|---|---|
| Opioids (oxycodone, morphine, codeine) | Profound sedation, respiratory depression, coma, death |
| Alcohol | Additive CNS depression, increased risk of overdose and death |
| Other CNS Depressants (antihistamines, muscle relaxants, sedatives) | Additive sedative effects, increased dizziness and ataxia |
| Antidepressants (SSRIs) | Additive CNS depression |
| CYP3A4 Inhibitors (ketoconazole, erythromycin, grapefruit juice) | Increased diazepam levels, prolonged sedation |
Tolerance, Dependence & Withdrawal
Tolerance: Reduced response to the same dose over time, requiring dose escalation for same effect.
Physical Dependence: The body adapts to the presence of the drug. Withdrawal symptoms may occur within 24-72 hours of last dose.
Withdrawal Symptoms (can be life-threatening):
- Rebound anxiety and panic attacks (worse than before treatment)
- Insomnia, vivid nightmares
- Irritability, agitation, confusion
- Tremors, sweating, tachycardia
- Seizures (grand mal)
- Psychosis (hallucinations, paranoia)
⚠️ Do Not Stop Abruptly
Diazepam withdrawal can be fatal. Tapering should be done under medical supervision, typically reducing by 1-2 mg every 2-3 weeks depending on duration of use and dose [citation:7].
Overdose Signs and Treatment
Overdose Signs:
- Severe drowsiness, confusion, slurred speech
- Impaired coordination (ataxia)
- Hypotension (low blood pressure)
- Respiratory depression (slow or shallow breathing)
- Coma
Overdose Treatment (Emergency):
- Flumazenil: Benzodiazepine antagonist — use with caution due to risk of seizures, especially in chronic benzodiazepine users or those with co-ingestion of pro-convulsant drugs (e.g., TCAs)
- Activated charcoal: If patient presents within 1-2 hours of ingestion and has intact airway
- Supportive care: Airway management, IV fluids, monitoring
Note: Overdose with benzodiazepines alone rarely causes death, but combined with alcohol or opioids is frequently fatal.
Use in Specific Populations
| Population | Consideration |
|---|---|
| Pregnancy | Category D. May cause fetal harm. Third-trimester use → neonatal sedation and withdrawal (hypotonia, apnea, feeding difficulties) [citation:3]. |
| Breastfeeding | Diazepam is excreted in breast milk. Monitor infants for sedation, poor feeding, and poor weight gain. |
| Geriatric (≥65 years) | Increased sensitivity. Long half-life increases fall risk, hip fractures, and cognitive impairment. Lower starting doses (2-2.5 mg daily) [citation:7]. |
| Hepatic Impairment | Significant dose reduction required. Metabolized primarily by the liver. Avoid in severe impairment. |
Storage and Disposal
- Storage: Store at room temperature (59-86°F / 15-30°C) in a secure, locked cabinet out of reach of children and visitors. Protect from light and moisture.
- Disposal: Use a drug take-back program or DEA-authorized collection site. If no take-back program is available, flush down the toilet (FDA recommendation for benzodiazepines when take-back is not available due to high risk of diversion and toxicity in children).
Legal Status (United States)
Diazepam is a Schedule IV (C-IV) controlled substance under the Controlled Substances Act [citation:3]. Key restrictions:
- Prescription required — refills permitted up to 5 times within 6 months
- DEA registration required for prescribing and dispensing (no mid-level restrictions beyond standard DEA)
- Illegal to possess without a valid prescription
- Penalties for illegal possession: up to 1 year imprisonment + fines (first offense)
Counterfeit Identification Guide (Educational)
The following signs are common in counterfeit “Actavis” or generic blue 10mg diazepam tablets [citation:1]:
| Characteristic | Genuine (if available) | Common Counterfeit |
|---|---|---|
| Imprint | “C | DC”, “D 10”, “3927 / TEVA”, “ROCHE”, “Z 3927 10” | Often replicas of “C DC” or “D 10” but blurry/incorrect font |
| Packaging | Child-resistant, rigid blister packs, clear printing [citation:1] | Flimsy blister packs, Actavis labeling but Actavis no longer manufacturers |
| Active Ingredients | Diazepam (10mg) | Etizolam, Flubromazolam, Bromazolam, or other research chemicals [citation:1] |
| Effect perception | Sedation, muscle relaxation, anxiolysis within 30-60 minutes | No effect (inactive) or overly strong/amnesic effects [citation:1] |
| Quantity | 50, 100, 250, 500, 1000 |
|---|


