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Halcion: An Independent Assessment of Safety and Efficacy Data (1997)
Institute of Medicine (IOM)

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. "Appendix A: FDA Safety Tables." Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press, 1997.

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Halcion: An Independent Assessment of Safety and Efficacy Data

TABLE A-7 Non-Geriatric Studies: Sedative/Hypnotic

TABLE 5.10

NON-GERIATRIC STUDIES: 'SEDATIVE/HYPNOTIC'

 

 

DOSE (MG)

 

% WITH 'SEDATIVE HYPNOTIC'

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

17.1

—

11.4

2401

1

.25-.5

—

145

75.0

—

84.4

6400

1

.25-.5

15-30

105

20.8

21.2

—

6041

1

.5

—

143

24.3

—

12.3

6042

1

..5

30

127

21.9

17.5

—

6004

1

.6

30

37

50.0

47.6

—

6043

2

.5

—

277

35.5

—

19.4

6016

2

.5

30

30

14.3

25.0

—

6044

2

.5

30

232

37.1

44.0

—

6402

4

.25

30

81

33.3

59.3

—

6045

4

.5

—

62

54.8

—

12.9

6046

4

.5

30

103

43.6

36.0

—

6047

6

.5

—

125

36.7

—

13.8

6048

6

.5

30

145

25.7

31.0

—

6023B

12

.5

30

18

41.7

50.0

—

6023

12

.6

30

51

33.3

77.8

—

6049

13

.5

30

139

37.8

42.5

—
Page
114