TABLE B-5 IOM Summary of Studies Investigating Possible Unique Amnestic Effects of Halcion

Source

Type

Population

Number of Subjects

Drug and Dose

Duration

Outcome/Comment

Roth et al. (1980)

Placebo/BZ

Bedtime

11

Placebo

Flurazepam 30 mg

Halcion 0.5 mg

Lorazepam 4 mg

2 nights/week over

4 weeks

Lorazepam equivalent to Halcion impairing, immediate and delayed (tested following morning) recall (both amnestic) vs. placebo and flurazepam. Flurazepam impairs vs. placebo to typical dose, but appropriate for the comparison. More rapid return to sleep may be a factor contributing to sleep may be a factor contributing to interference with memory consolidation with Halcion (difference in minutes).

Spinweber and Johnson (1982)

Placebo

Male, insomniac

10

10

Halcion 0.5 mg

Placebo

6 treatment nights

2 withdrawal

Reaction time, digit symbol, Williams Word Memory and Card Song Sorting Deficits Evident Immediate to 5 h after drug administration. Paired associate task administered prior to Halcion did not show a.m. memory, impairment.

Roehrs et al. (1983)

Placebo/flurazepam secobarbital

Male, Bedtime

12

Halcion 0.25 and 0.5 mg

Placebo

Flurazepam 30 mg

Secobarbital 200 mg

Lorazepam 4 mg

6 days of administration for each agent, 1 day of withdrawal

Halcion memory impairment was dose-dependent. Acute: lorazepam = Halcion, 25 = flurazepam < Halcion. 0.5 = Secobarbital. Over 6 days no change with Halcion or secobarbital. Effect from flurazepam worsened (accumulation?) to equal that of Halcion at 5 mg. Tolerance to lorazepam appeared to develop.

Scharf et al. (1988)

Three studies

Bedtime

Insomniac

Insomniac

22

22

30

Halcion 0.5 mg/placebo

Halcion 0.5 mg/placebo

Temazepam 30 mg

Single dose

Halcion, but not temazepam, showed. evidence of anterograde memory impairment.

Greenblatt et al. (1989)

Placebo/active

Bedtime

16

12

13

11

Placebo

Flurazepam 15 mg

Temazepam 15 mg

Halcion 0.25 mg

Single dose

List learning at 24 h: Halcion < flurazepam = temazepam placebo. Possible bias against Halcion from a State Department learning perspective.

Penetar et al. (1989)

Placebo

Bedtime, Aerial Deployment

33

35

Halcion 0.5 mg

Placebo

Single dose

Logical memory WMS impairment at 8 h by Halcion vs. placebo. Stimuli presented while receiving drug.

Griffiths et al. (1986)

Placebo/active

Bedtime (within subject)

10

Zopiclone 7.5 mg

Flurazepam 15 mg

Lormetazepam 1 mg

Halcion 0.25 mg

Placebo

Single dose

Stroop, memory span, logical reasoning, mood, and saccadic eye movement all were similarly drug sensitive.



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