Dexmedetomidine hydrochloride as a long-term sedative

Figures & data

Table 1 Countries with dexmedetomidine approval (Primary indication)

Type of indication	Status	Number of countries	Approved maximum dose	Approved maximum duration	Year of approval	Country
Only in the ICU setting	Approval	38	0.7 μg · kg^−1 · h^−1	24 h	1999	USA
					2000	Peru	Argentina	Uruguay	Venezuela	Colombia	Ecuador
						Puerto Rico	Singapore	Kuwait
					2001	Dominican Republic	Malaysia	Vietnam	Bulgaria	Poland	Bahrain
						Qatar	Syria	United Arab Emirates
					2002	Australia	Hong Kong	Indonesia	New Zealand	Czech Republic	Turkey
						Saudi Arabia	South Africa	Jordan
					2004	Japan	Mexico	Taiwan
				No restriction on long-term use	2005	Brazil
				24 h		Chile
				24 h	2006	Philippines	Thailand
				No restriction on long-term use	2008	Guatemala
				24 h	2009	Canada
					2010	Korea

Table 2 Countries with dexmedetomidine approval (Increasing indication)

Type of indication	Status	Number of countries	Approved maximum dose	Approved maximum duration	Year of approval	Country
Prolonged	Approval	6	1.4 μg · kg^−1 · h^−1	No restriction on long-term useb	2008	Colombia
			1.1 μg · kg^−1 · h^−1a		2008	Dominican Republic
			1.1 μg · kg^−1 · h^−1a		2009	Uruguay	Ecuador	Mexico
			0.7 μg · kg^−1 · h^−1	No restriction on longterm usec	2010	Japan
	Before approval after clinical trial	5	1.4 μg · kg^−1 · h^−1	30 daysd	2007e	USA	Australia	Brazil	Argentina	New Zealand
Procedural sedation	Approval	13	1.0 μg · kg^−1 · h^−1	24 h	2008	USA	Colombia	Guatemala	Philippines
			1.0 μg · kg^−1 · h^−1		2009	Canada	Ecuador	Mexico	Australia	Malaysia	Jordan
						Uruguay
			1.0 μg · kg^−1 · h^−1		2010	New Zealand	Korea

a Notes: 1.4 μg · kg⁻¹ · h⁻¹ during the clinical trial;

b Up to 30 days during the clinical trial;

c Up to 28 days during the clinical trial;

d During the clinical trial;

e End of the clinical trial.