Dexmedetomidine
Other Hypnotics and Sedatives
Sold as Dexdor · PRECEDEX
- Drug class
- Other Hypnotics and Sedatives
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 4
- Products on record
- 36
- FDA reports (12 mo)
- 479
Overview
Dexmedetomidine is an active pharmaceutical ingredient in the Other Hypnotics and Sedatives group (N05CM). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 18 | May 22, 2026 |
| CA Canada | Health Canada | 14 | February 24, 2026 |
| US United States | FDA | 3 | May 27, 2026 |
| EU European Union | EMA | 1 | January 28, 2026 |
GBUnited Kingdom· MHRA
18 products
Uses
For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3). , procedural/awake sedation.
How to take
CACanada· Health Canada
14 products
Uses
Precedex® (Dexmedetomidine Hydrochloride for Injection, Dexmedetomidine Hydrochloride Injection) is indicated for: • Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting by continuous intravenous infusion.
The Precedex® infusion should not generally exceed 24 hours. Precedex® has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex® prior to extubation.
• Conscious Sedation Precedex® is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures by continuous intravenous infusion for the following procedures: - Monitored Anesthesia Care (MAC) with an adequate nerve block and/or local infiltration; and - Awake Fiberoptic Intubation (AFI) with adequate topical preparation of the upper airway with local lidocaine formulations.
USUnited States· FDA
3 products
Uses
1 INDICATIONS AND USAGE Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha 2 adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting.
Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours. 1) • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. 1 Intensive Care Unit Sedation Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting.
Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection should be administered by continuous infusion not to exceed 24 hours. 2 Procedural Sedation Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
EUEuropean Union· EMA
1 product
Uses
For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3). e. procedural/awake sedation.
How to take
Drug interactions
Known interactions involving Dexmedetomidine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 320. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL528080002 · revised July 4, 2025
- [2]Health Canada (DPD) · 02437147 · revised March 22, 2025
- [3]FDA DailyMed · 0d2710f2-ee47-41… · revised May 27, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/002268 · revised January 28, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.