Description

Dormicum (midazolam) is a short‑acting benzodiazepine sedative used for procedural sedation, premedication before anesthesia, induction of anesthesia, and sedation in intensive care settings. It offers rapid onset, anxiolytic, amnestic, and muscle‑relaxant effects. 

2. Prescription

This is a prescription‑only medicine, typically administered in medical facilities by trained healthcare professionals. 

3. Therapeutic Category

Classified as a hypnotic/sedative benzodiazepine (ATC code: N05CD08), Dormicum is used for sedation and anesthesia-related purposes.

4. Active Ingredients / Composition

• Active Ingredient: Midazolam hydrochloride, at a concentration of 1 mg/mL (5 mg in 5 mL ampoule). 
• Excipients: Includes sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection.

5. Vitamins

Not applicable—this is not a vitamin-containing product.

6. Minerals

Not applicable.

7. Variant

Dormicum is available in multiple formulations:

• 5 mg/5 mL ampoule
  
• 15 mg/3 mL ampoule
  These allow different dosing scenarios and routes (IV, IM, rectal).

8. Consume (Administration) Types

Administered via intravenous (IV), intramuscular (IM), and in some regions rectal routes. It’s meant for parenteral use only. 

9. Directions / Usage

• Adults: For IV sedation, initial dose 2.5 mg, titrate by 1 mg until desired effect (max ~5 mg); for IM use, 5 mg 30‑60 minutes before procedure. 
• General: Administer slowly—the recommended IV rate is approximately 1 mg per 30 seconds. IM route used when IV access isn’t practical. 
• Adjust dose for elderly and those with liver/kidney impairment. 

10. Common Side Effects

• Serious (life-threatening): Allergic reactions (anaphylaxis), respiratory depression, laryngospasm, hypotension, cardiac arrest—especially with rapid or high-dose administration. 
• Other reported effects: Confusion, drowsiness, memory loss (anterograde amnesia), agitation, paradoxical reactions (particularly in children and elderly), nausea, injection-site effects, muscle tremors, risk of dependence and withdrawal with prolonged use, falls and fractures. 

11. Package Type

Typically supplied in cardboard boxes containing 10 glass ampoules (Type I, Ph. Eur.), each holding 5 mL. 

12. Storage Advice

• Store up to 25–30 °C in original packaging to protect from light.
• Keep out of reach of children; discard unused portion if ampoule is damaged or contents are discolored.

13. Safety Advice

• Professional use only; monitor vital signs and respiratory function during administration.
• Inform patients about amnesia—post-procedure supervision is required.
• Caution with respiratory insufficiency, sleep apnea, neuromuscular disorders, pregnancy, or co-administration with other CNS depressants.  
• Titrate dosage carefully and avoid rapid IV bolus due to risk of hypotension or respiratory collapse. 

14. Product Substitutes

Other benzodiazepines used for similar sedation/anesthesia purposes include:

• Diazepam
• Lorazepam
• Other sedatives like propofol, ketamine (depending on procedural need)

15. Manufacturer / Marketer

Dormicum injection is manufactured by:

• CENEXI, France
• CHEPLAPHARM Arzneimittel GmbH, Germany
  Marketing authorization holders vary by region (e.g., Roche).

16. Country of Origin

Typically France (CENEXI) or Germany (CHEPLAPHARM), depending on supply chain and region.