TABLE B-9 IOM Summary of Studies Investigating Possible Unique Psychotigenic, Confusion, or Dissociation-Generating Effects of Halcion

Source

Type

Population

Number of Subjects

Drug and Dose

Duration

Outcome/Comments

Greenblatt et al. (1989)

Placebo, flurazepam, temazepam

Bedtime

16

Placebo

Single dose

''Spacey." Halcion temazepam > flurazepam = placebo. Halcion effects were at 6 h. Highly correlated with sedation.

12

Flurazepam 15 mg

13

Temazepam 15 mg

11

Halcion 0.25 mg

Pinnock et al. (1985)

Placebo, diazepam

Medical

28

Placebo

Single dose

Letter search. No significant difference at 6 h.

30

Diazepam 10 mg

29

Halcion 0.25 mg

Elie et al. (1990)

Zopiclone

Elderly insomniacs

44

Halcion 0.125 mg

3 weeks

Nightmares in 5 patients not associated with treatment.

Halcion 0.25 mg

Zopiclone 5 mg

Zopiclone 7.5 mg

Bonnet and Arand

Placebo, dose

Elderly insomniac (within subject)

12

Placebo

4-day episodes

Subjects receiving Halcion at 0.25 mg were initially worse on a.m. addition and vigilance. Better than placebocebo after 4 days.

Halcion 0.125 mg

Halcion 0.25 mg

Roger et al. (1993)

Zolpidem

Elderly insomniac inpatients

70

Zolpidem 5 mg

3 weeks

 

74

Zolpidem 10 mg

77

Halcion 0.25 mg

Wehli et al. (1985)

Placebo, midazolam

Trainee pilots

8

Placebo

Single dose, tested 7 h later

More pilot errors with Halcion relative to placebo and midazolam (flight simulator).

8

Midazolam 15 mg

8

Halcion 0.5 mg

Adam and Oswald (1988)

Placebo

Insomnia

40

Halcion 0.5 mg

15 nights of placebo,

Three patients developed paranoid psychoses with visual hallucinations.

40

Lormetazepam 2 mg

25 nights of medication,

40

Placebo

5 nights placebo



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