Diazepam

The US label lists several uses. The first is the management of anxiety disorders or short-term relief of anxiety symptoms. It notes that everyday stress usually does not need treatment.

It is also used for symptom relief in acute alcohol withdrawal, as an add-on for muscle spasm from inflammation, injury or nerve conditions, and as an add-on in convulsive disorders.

The label says long-term effectiveness beyond 4 months has not been studied, so the prescriber should reassess use regularly.

• Anxiety disorders and short-term anxiety relief
• Acute alcohol withdrawal (agitation, tremor, delirium tremens)
• Skeletal muscle spasm (add-on)
• Convulsive disorders (add-on only)

The label sections we reviewed do not describe how diazepam works.

The label describes diazepam as a benzodiazepine derivative. Benzodiazepines slow brain activity, which has calming and muscle-relaxing effects.

The dosing here comes from a US tablet label (diazepam tablets, taken by mouth) for adults. Other Indian pack forms exist, and the prescriber decides.

The US label for adults gives a usual daily dose by use. Anxiety: 2 mg to 10 mg, 2 to 4 times daily. Muscle spasm: 2 mg to 10 mg, 3 or 4 times daily. Convulsive disorders (add-on): 2 mg to 10 mg, 2 to 4 times daily.

Acute alcohol withdrawal: 10 mg, 3 or 4 times in the first 24 hours, then 5 mg, 3 or 4 times daily as needed.

For elderly or debilitated people the label says 2 mg to 2.5 mg, once or twice daily at first, raised gradually.

The label says to use a gradual taper when stopping, to lower the risk of withdrawal reactions.

This is label information, not a prescription. Indian pack labels may differ from the US label, and your prescriber's instruction always comes first.

Boxed warning: using benzodiazepines with opioids may cause profound sedation, slowed breathing, coma and death. The label also warns of abuse, misuse and addiction, and of dependence and withdrawal that can be life-threatening after sudden stopping.

Not for people with known hypersensitivity, myasthenia gravis, severe respiratory insufficiency, severe liver insufficiency, sleep apnea, or acute narrow-angle glaucoma. Not for infants under 6 months.

Alcohol: the label says use with alcohol is not recommended because it adds to sedation.

Elderly: the label advises the smallest effective dose because of the risk of unsteadiness and over-sedation.

Kidney impairment: metabolites leave through the kidney, so the label says to take care with dose.

Pregnancy: use late in pregnancy may cause sedation or withdrawal in newborns.

Breastfeeding: diazepam passes into milk. The label says breastfeeding is not recommended during treatment.

Alertness: do not drive or use machinery until you know how it affects you.

• Opioids: serious breathing risk
• Alcohol: more sedation, not advised
• Other sedating medicines: added effects
• Antacids: lower peak levels
• Opioids: using them together increases the risk of slowed breathing and sedation.
• The label says to limit dose and duration.
• Alcohol: the label says use together is not recommended because of added sedation.
• Other centrally acting medicines, such as sedatives, antipsychotics, antidepressants, sedative antihistamines and anticonvulsants, may add to or be affected by diazepam.
• Antacids taken at the same time lower diazepam's peak concentration by about 30%.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says benzodiazepine overdose causes central nervous system depression, from drowsiness to coma. Severe cases can cause slowed breathing. With alcohol or opioids it may be fatal.

Treatment is supportive, with fluids and airway management. Flumazenil carries risks, including seizures. Get emergency help.

The label says to store tablets at 20 to 25 degrees C (68 to 77 degrees F) and to protect them from light.

It also says to keep the medicine out of the reach of children.

In the Drugs Rules schedules we checked, diazepam is listed under Schedule H1 (Schedule H1, serial 22 (rules 65 and 97)). Schedule H1 medicines are sold only on a doctor's prescription, and the pharmacy records the sale. Diazepam is a benzodiazepine, so treat it as a controlled medicine.

Diazepam appears in the National List of Essential Medicines 2022 on page 65 and 84. Listed forms include an injection 5 mg per mL, a 5 mg suppository and tablets, under more than one section.

NPPA lists ceiling prices for several diazepam formulations. The table shows the rows we found. Check NPPA directly for the current list.

Banned combinations: 3 mentions of diazepam in the banned-combination list we checked. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. Check the pack and the seller.

Jan Aushadhi (PMBJP) lists diazepam products in the file we checked. We have not shown a brand price here.

• Diazepam Tablets IP 5 mg (pack 10's)
• Diazepam Injection IP 5mg per ml (pack 2 ML)
• Diazepam Tablets IP 2 mg (pack 10's)
• Diazepam Tablets IP 10 mg (pack 10's)