Halcion: An Independent Assessment of Safety and Efficacy Data

TABLE B-7 IOM Summary of Studies Investigating Possible Unique Ataxic or Dyscoordination Effects of Halcion

Source	Type	Population	Number of Subjects	Drug and Dose	Duration	Outcome/Comments
Open Label
Gales and Menard (1995)	Matched group	Hospitalized elderly ± falls	100 with fails	Mixed	17 mo	Benzodiazepines received by more falling patients (40% vs. 20%; odds ratio, 2.7). Falls more common in patients with three or more psychoactive medication.
			100 without falls
Cooper (1994)	Case-control	Elderly	44	No drug or receiving psychotropic drugs	6 mo	Number of subjects was too small to draw inferences about specific drugs.
			38
Double-Blind
Fleming et al.	Zopiclone	Insomniacs	24	Zopiclone 7.5 mg	21 days	In first week of withdrawal, psychomotor behavior worse in Halcion group on the basis of subjective report.
			24	Halcion 0.25 mg
Chaudoir et al.	Zopiclone	Insomniacs	19	Zopiclone 7.5 mg	2 weeks	Improved alertness in a.m. and improved sense of balance and coordination.
			19	Halcion 0.25 mg
Robin et al. (1996)	Placebo	Elderly Young	9	Halcion 0.375 mg	Single dose	Increased body sway with Halcion in elderly subjects. No greater magnitude of change in the elderly. Rather, elderly start with greater baseline body sway. More loss of balance ("fall") in elderly subjects receiving Halcion, also predicted by baseline body sway.
			9	Placebo
SOURCES: Cooper (1994) and Robin et al. (1996).