Halcion: An Independent Assessment of Safety and Efficacy Data

Questions? Call 800-624-6242

About | Ordering | New

LoginRegister

| Items in cart [0]

PAPERBACK
price:$39.00
add to cart

Rights & Permissions

Free PDF Access

Free Resources

Related Titles

Halcion: An Independent Assessment of Safety and Efficacy Data (1997)
Institute of Medicine (IOM)

Citation Manager Export the bibliographic data for this book in your chosen format
Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web.
Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book.
Reference Finder Paste in your own text to find books that relate to your topic.

Citation Manager

. "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.

Please select a format:

Page
133


E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.

Halcion: An Independent Assessment of Safety and Efficacy Data

TABLE B-6 IOM Summary of Studies Investigating Possible Unique Anxiogenic Effects During Administration of Halcion, and Anxiogenic or Insomnia-Promoting Effects with Withdrawal

Source	Type	Population	Number of Subjects	Drug and Dose	Duration	Outcome/Comments
Greenblatt et al. (1989)	Placebo, active drug	Bedtime	16 12 13 11	Placebo Flurazepam 15 mg Temazepam 15 mg Halcion 0.25 mg	Single dose	Halcion only hypnotic to initially slow thinking speed. Similar increase above baseline for all but flurazepam at 24 h. Increased thinking speed could be related
Pinnock et al. (1985)	Placebo, diazepam	Medical	28 30 29	Placebo Diazepam 10 mg Halcion 0.25 mg	Single dose presurgery	VAS anxiety diazepam, but not Halcion acutely anxiolytic; no difference 6 h postawakening.
Kales et al. (1986)	Placebo, quazepam; sleep laboratory	Insomnia	6 6	Placebo, Halcion 0.25 mg Placebo, Quazepam 15 mg	2 days then 14 days; 3-day withdrawal	Carryover sedation with quazepam. (SWS suppression) rebound insomnia with halcion. Rate of "excitatory" effects reported to be 0.5 for Halcion vs. 0.14 for quazepam. Withdrawal-related anxiety/panic for Halcion ("excitatory effects": anxiety, hyperarousal, inability to concentrate, paranoid ideation, nightmares). Not clear that quazepam group was followed long enough to adequately rule out rebound (loss of quazepam).
Hegelbach-Feller et al. (1988)	Placebo, midazepam; crossover	Insomnia	30	Placebo Halcion 0.5 mg Midazepam 15 mg	11 days	More rebound decline in sleep quantity and restlessness during night with Halcion.
Lee and Lader (1988)	Placebo, quazepam; crossover	Bedtime	12	Placebo Quazepam 15 mg	14 days	Mild rebound anxiety more clear with quazepam. Withdrawal-related onset of metallic taste with Halcion.
Fleming et al. (1990)	Zopiclone	Insomniacs	24 24	Zopiclone 7.5 mg Halcion 0.25 mg	21 days	In first week of withdrawal subjective agitation equivalent: 3 zopiclone, 2 Halcion.
Mouret et al. (1990)	Zopiclone	Elderly insomniacs	10	Halcion 0.25 mg Zopiclone 7.5 mg	15 days.	Withdrawal insomnia during treatment with zopiclone but not Halcion; 3 days for Halcion vs. 2 days for zopiclone. Did not see "extremely marked" withdrawal as described by Kales et al. (1976, 1983).
Elie et al. (1990)	Zopiclone	Elderly insomniacs	44	Halcion 0.125 mg Halcion 0.25 mg Zopiclone 5 mg Zopiclone 7.5 mg	3 weeks	After withdrawal from Halcion, increased sleep latency and decreased sleep soundness end quality for 3 days. No significant change with zopiclone.