. "Appendix B: Summary Tables of Literature Reviewed for Safety of Halcion." 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 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.
temazepam > flurazepam = placebo. Halcion effects were at 6 h. Highly correlated with sedation.