TABLE B-10 IOM Summary of Studies Investigating Other Possible Adverse Events Related to Halcion

Source

Type

Population

Number of Subjects

Drug and Dose

Duration

Outcome/Comments

Fleming et al. (1990)

Zopiclone

Insomniacs

24

Zopiclone 7.5 mg

21 days

Early termination: 10/24 (42%) Halcion, 2/24 >(8%) zopiclone, chi-square = 5.4, p < 0.02. Subjects receiving zopiclone had taste changes. Moderate to severe adverse effects: 18% zopiclone, 42% Halcion (p < 0.05). Combined dropouts from lack of efficacy and side effects.

24

Halcion 0.25 mg

Thorpy et al. (1991)

Single blind

Narcoleptics

10

Halcion 0.25 mg

 

No unexpected side effects.

Roehrs et al. (1992)

Taper rate

Insomniacs with normal sleep; Insomniacs without normal sleep; Bedtime

7

Halcion 0.5 mg

 

Bedtime did not use pm to restore sleep during withdrawal. Insomniacs did use pm, Halcion, and placebo, although not differently.

7

7

Roger et al. (1993)

Zolpidem

Elderly insomniac inpatient

70

Zolpidem 5 mg

3 weeks

Rate of AE (CNS AEs): 16% (10%) zolpidem 5 mg, 11% (11%) zolpidem 10 mg, 21% (16%) Halcion. One patient withdrew for tremor and malaise. Total withdrawal: 1 zolpidem 5 mg, 1 zolpidem 10 mg, 5 Halcion (1 inefficacy, 2 for AEs, and 2 for "other reasons").

74

Zolpidem 10 mg

77

Halcion 0.25 mg

Mauri et al. (1993)

Quazepam

Insomniac outpatients

32

Quazepam 15 mg

8 weeks

No unexpected effects.

33

Halcion 0.5 mg

Jacobson et al. (1994)

Placebo

Surgery for breast cancer

49

Halcion 0.125 mg increased to 0.25 mg pm.

3 nights

Halcion effective, less likely increased to 0.25 mg (2 caps) then placebo (7/49 vs. 15/51). Halcion proscription associated with less opiate (acetaminophen + oxycodone) use. No adverse reaction significantly more frequent in Halcion group.

51

Placebo to 2 caps pm.



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