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).



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