VALIUM 10MG TABS 25S

Valium (Diazepam) is one of the most widely used benzodiazepines worldwide and is included on the WHO Model List of Essential Medicines.

Valium (Diazepam)  is a long-acting benzodiazepine with an elimination half-life of 20–100 hours; its active metabolite, desmethyldiazepam, has an even longer half-life of 36–200 hours, contributing to prolonged pharmacological effects and accumulation with repeated dosing.

Diazepam is approved for: anxiety disorders and acute anxiety states; acute alcohol withdrawal (delirium tremens); skeletal muscle spasm and spasticity; status epilepticus (IV formulation) and epilepsy adjunct therapy; pre-operative sedation and anxiolysis; and acute agitation. It is also used for procedural sedation, including alongside anaesthesia with ketamine.

In Kenya, both the branded Valium 10 mg and the generic Cozepam 5 mg tablets are available and pharmacologically equivalent. This monograph covers both products, which contain the same active ingredient at different strengths.

Diazepam tablets should be taken orally with water. Dose varies widely based on indication. Use the lowest effective dose for the shortest possible duration.

Anxiety Disorders

•     Adults: 2–10 mg orally 2–4 times daily, adjusted to response.

•     Elderly patients: Start with 2–5 mg once or twice daily due to prolonged half-life and accumulation risk.

Acute Alcohol Withdrawal

•     10 mg orally 3–4 times during the first 24 hours, then reducing to 5 mg 3–4 times daily as required.

•     Managed in clinical settings where seizure risk can be monitored.

Muscle Spasm

•     5–10 mg orally 3 times daily.

Sedation / Pre-operative Anxiolysis

•     5–10 mg orally 1–2 hours before the procedure.

Special Populations

•     Elderly: Markedly reduced doses; accumulation of long-acting metabolites substantially increases fall and sedation risk.

•     Hepatic impairment: Reduce dose; avoid in severe hepatic impairment.

•     Children: Use is specialist-guided and indication-specific; diazepam is used for acute seizure management in paediatric patients.

Side effects vary in frequency and severity. Not every patient will experience all listed effects. Seek immediate medical attention for any serious or unexpected reactions.

•     Opioid co-administration (Black Box Warning in many countries): Combining diazepam with opioids can cause profound respiratory depression, coma, and death. Avoid unless no alternative exists; monitor closely.

•     Dependence: Physical and psychological dependence occurs even at therapeutic doses after 4–6 weeks of daily use. Never stop abruptly, taper gradually.

•     Long-acting metabolites: Diazepam and its active metabolites persist for days, causing accumulation, especially relevant in elderly, renally or hepatically impaired patients.

•     Cognitive impairment: Prolonged use is associated with impaired memory and cognitive function. Risk is particularly high in elderly patients (Beers Criteria, high-risk in older adults).

•     Driving and machinery: Significantly impairs psychomotor performance. Patients must not drive until they know their individual response.

•     Pregnancy and lactation: Teratogenic risk in the first trimester. Neonatal toxicity ("floppy infant syndrome") and withdrawal can occur with third trimester exposure. Passes into breast milk.

The following interactions are clinically significant. Always inform your healthcare provider of ALL medicines, supplements, and herbal products you are taking.

•     Opioids (morphine, tramadol, codeine): Potentially fatal respiratory depression; this combination is a black-box warning interaction.

•     Alcohol: Profound additive CNS depression; avoid entirely.

•     Other CNS depressants (barbiturates, antipsychotics, antihistamines): Enhanced sedation.

•     MAO inhibitors and antidepressants: May potentiate CNS depression.

•     Antacids: Reduce peak plasma concentrations by approximately 30% (slowed absorption); clinical relevance usually minor.

•     CYP2C19 inhibitors (omeprazole, fluvoxamine): May increase diazepam plasma levels.

•     Cimetidine: Inhibits diazepam metabolism, increasing plasma levels.

•     Rifampicin: Induces diazepam metabolism, reducing efficacy.

Store below 25°C. Protect from light and moisture. Keep in original packaging. Store in a locked, secure location as a controlled substance. Keep out of reach of children.

Diazepam is a Schedule IV controlled substance in Kenya. Valium 10 mg and Cozepam 5 mg are bioequivalent; counsel patients accordingly. Verify prescription validity and watch for signs of dependence or doctor-shopping. Screen for opioid co-prescriptions (this is the most dangerous drug interaction). Elderly patients on diazepam are at very high risk of falls, flag this to the prescriber. Document all dispensing in the controlled drugs register. For patients presenting prescriptions for large quantities or at high frequency, exercise professional judgment and consult the prescriber if concerned.

Q1: What is the difference between Valium 10 mg and Cozepam 5 mg?

A: Both contain diazepam, the same active ingredient. Valium 10 mg is the brand version at a higher strength; Cozepam 5 mg is a generic at half the dose. Both are therapeutically equivalent when prescribed appropriately.

Q2: How long can I take diazepam safely?

A: Diazepam is recommended for short-term use only, generally 2 to 4 weeks for anxiety. Longer use leads to tolerance (needing more for the same effect) and physical dependence, making stopping very difficult.

Q3: Why is it dangerous to take diazepam with painkillers like tramadol or morphine?

A: Both diazepam and opioid painkillers depress the central nervous system and slow breathing. Together, the effect on breathing is multiplied and can be fatal. This combination must be avoided unless there is no alternative and monitoring is in place.

Q4: Can diazepam be used during pregnancy?

A: Diazepam is generally avoided in pregnancy. Use in the first trimester has been associated with birth defects (cleft palate). Use in the third trimester can cause "floppy infant syndrome" (low muscle tone) and neonatal withdrawal in the newborn. Discuss all risks with your doctor.

Q5: Is diazepam addictive?

A: Yes. Physical and psychological dependence can develop even at prescribed doses within 4–6 weeks of daily use. This does not mean it is wrong to use it short-term, but it must be used carefully and stopped gradually under medical supervision.