References

Adam, K., and I. Oswald. 1988. Can a rapidly-eliminated hypnotic cause daytime anxiety? Pharmacopsychiatry (22):115-119.

Arendt, R. M., D. J. Greenblatt, D.C. Liebisch, M. D. Luu, and S. M. Paul. 1987. Determinants of benzodiazepine brain uptake: lipophilicity versus binding affinity. Psychopharmacology 93:72-76.


Balter, M. B., and E. H. Uhlenhuth. 1991. The beneficial and adverse effects of hypnotics. Journal of Clinical Psychiatry 52:16-23.

Balter, M. B., and E. H. Uhlenhuth. 1992. New epidemiologic findings about insomnia and its treatment. Journal of Clinical Psychiatry 53(Suppl.):34-93.

Baughman, V. L., G. L. Becker, C. M. Ryan, M. Glaser, J. P. Abenstein. 1989. Effectiveness of triazolam, diazepam, and placebo as preanesthetic medications. Anesthesiology 71(2):196-200.

Beck, C. H., and H. C. Fibiger. 1995. Conditioned fear-induced changes in behavior and in the expression of the immediate early gene c-fos: with and without diazepam pretreatment. Journal of Neuroscience 15(1 Pt 2):709-720.

Berlin, I., D. Warot, T. Hergueta, P. Molinier, C. Bagot, and A. I. Puech. 1993. Comparison of the effects of zolpidem and triazolam on memory functions, psychomotor performances, and postural sway in healthy subjects. Journal: of Clinical Psychopharmacology 13:100-106.

Bixler, E. O., A. Kales, R. L. Manfredi, A. N. Vgontzas, K. L. Tyson, and J. D. Kales. 1991. Next-day memory impairment with triazolam use. Lancet 337(8745):827-831.

Bliwise, D. L. 1991. Treating insomnia: pharmacological and nonpharmacological approaches. Journal of Psychoactive Drugs 23(4):335-341.



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Halcion: An Independent Assessment of Safety and Efficacy Data References Adam, K., and I. Oswald. 1988. Can a rapidly-eliminated hypnotic cause daytime anxiety? Pharmacopsychiatry (22):115-119. Arendt, R. M., D. J. Greenblatt, D.C. Liebisch, M. D. Luu, and S. M. Paul. 1987. Determinants of benzodiazepine brain uptake: lipophilicity versus binding affinity. Psychopharmacology 93:72-76. Balter, M. B., and E. H. Uhlenhuth. 1991. The beneficial and adverse effects of hypnotics. Journal of Clinical Psychiatry 52:16-23. Balter, M. B., and E. H. Uhlenhuth. 1992. New epidemiologic findings about insomnia and its treatment. Journal of Clinical Psychiatry 53(Suppl.):34-93. Baughman, V. L., G. L. Becker, C. M. Ryan, M. Glaser, J. P. Abenstein. 1989. Effectiveness of triazolam, diazepam, and placebo as preanesthetic medications. Anesthesiology 71(2):196-200. Beck, C. H., and H. C. Fibiger. 1995. Conditioned fear-induced changes in behavior and in the expression of the immediate early gene c-fos: with and without diazepam pretreatment. Journal of Neuroscience 15(1 Pt 2):709-720. Berlin, I., D. Warot, T. Hergueta, P. Molinier, C. Bagot, and A. I. Puech. 1993. Comparison of the effects of zolpidem and triazolam on memory functions, psychomotor performances, and postural sway in healthy subjects. Journal: of Clinical Psychopharmacology 13:100-106. Bixler, E. O., A. Kales, R. L. Manfredi, A. N. Vgontzas, K. L. Tyson, and J. D. Kales. 1991. Next-day memory impairment with triazolam use. Lancet 337(8745):827-831. Bliwise, D. L. 1991. Treating insomnia: pharmacological and nonpharmacological approaches. Journal of Psychoactive Drugs 23(4):335-341.

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Halcion: An Independent Assessment of Safety and Efficacy Data Bliwise, D. L., W. F. Seidel, S. A. Cohen, N. G. Bliwise, and W. C. Dement. 1988. Profile of mood state changes during and after 5 weeks of nightly triazolam administration. Journal of Clinical Psychiatry 49(9):349-355. Bonnet, M. H., and D. L: Arand. 1990. The use of triazolam in older patients with periodic leg movements, fragmented sleep and daytime sleepiness. Journal of Gerontology 45(4):139-144. Bonnet, M. H., and D. L. Arand. 1991. Chronic use of triazolam in patients with periodic leg movements, fragmented sleep and daytime sleepiness. Aging (Milano) 3:313-324. Chaudoir, P. J., N. L. Bodkin, J. O'Donnell, A. Anderson, and R. L. Holland. 1990. A comparative study of zopiclone and triazolam in patients with insomnia. International Clinical Psychopharmacology 5(Suppl. 2):21-27. Derry, C. L., P. D. Kroboth, A. L. Pittenger, F. J. Kroboth, S. E. Corey, and R. B. Smith. 1995. Pharmacokinetics and pharmacodynamics of triazolam after two intermittent doses in obese and normal-weight men. Journal of Clinical Psychopharmacology 15:197-205. Ducic, I., G. Puia, S. Vicini, and E. Costa. 1993. Triazolam is more efficacious than diazepam in a broad spectrum of recombinant GABAA receptors. European Journal of Pharmacology 244:29-35. Eberts, F. S., Jr., Y. Philopoulos, L. M. Reineke, and R. W. Vliek. 1981. Triazolam disposition. Clinical Pharmacology and Therapeutics 29:81-93. Elie, R., M. Frenay, P. Le Morvan, and J. Bourgouin. 1990. Efficacy and safety of zopiclone and triazolam in the treatment of geriatric insomniacs. International Clinical Psychopharmacology 2(Suppl.):39-46. Faure-Halley, C., D. Graham, S. Arbilla, and S. Z. Langer. 1993. Expression and properties of recombinant alpha 1 beta 2 gamma 2 and alpha 5 beta 2 gamma 2 forms of the rat GABAA receptor. European Journal of Pharmacology 246:283-287. Fernandez-Guardiola, A., and J. L. Jurado. 1981. The effect of triazolam on insomniac patients using a laboratory sleep evaluation. Current Therapeutics Research 29:950-958. Fleming, J. A., D. J. McClure, C. Mayes, R. Phillips, and J. Bourgouin. 1990. A comparison of the efficacy, safety and withdrawal effects of zopiclone and triazolam in the treatment of insomnia. International Clinical Psychopharmacology 2(Suppl.):29-37. Gales, B. J., and S. M. Menard. 1995. Relationship between the administration of selected medications and falls in hospitalized elderly patients. Annals of Pharmacotherapy 29(4):354-358. Gibbons, R. D., D. R. Hedeker, I. Elkin, C. Waternaux, H. C. Kraemer, J. B. Greenhouse, M. T. Shea, S. D. Imber, S. M. Sotsky, and J. T. Watkins. 1993. Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Archives of General Psychiatry 50:739-750. Gibbons, R. D., D. R. Hedeker, S.C. Charles, and P. Frisch. 1994. A random-effects probit model for predicting medical malpractice claims. Journal of the American Statistical Association 89:760-767. Gillin, J. C., C. L. Spinweber, and L. C. Johnson. 1989. Rebound insomnia: a critical review. Journal of Clinical Psychopharmacology 9:161-172.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data Gillin, J. C., M. Rapaport, M. K. Erman, et al. 1997. A comparison of nefazodone and fluoxetine on mood and objective, subjective and clinician-rated measures of sleep in depressed patients: a double-blind g-week clinical trial. Journal of Clinical Psychiatry 58:185-192. Graham, D., C. Faure, F. Besnard, and S. Z. Langer. 1996. Pharmacological profile of benzodiazepine site ligands with recombinant GABAA receptor subtypes. European Neuropsychopharmacology 6:119-125. Grant, S. J., Y. H. Huang, and D. E. Redmond, Jr. 1980. Benzodiazepines attenuate single unit activity in the locus coeruleus. Life Sciences 27(23):2231-2236. Greenblatt, D. J., J. S. Harmatz, L. Shapiro, N. Engelhardt, T. A. Gouthro, and R. I. Shader. 1991. Sensitivity to triazolam in the elderly. New England Journal of Medicine 324:1691-1698. Greenblatt, D. J., R. I. Shader, M. Divoll, and J. S. Harmatz. 1984. Adverse reactions to triazolam, flurazepam, and placebo in controlled clinical trials. Journal of Clinical Psychiatry 45:192-195. Greenblatt, D. J., J. S. Harmatz, N. Engelhardt, and R. I. Shader. 1989. Pharmacokinetic determinants of dynamic differences among three benzodiazepine hypnotics. Archives of General Psychiatry, 46:326-332. Hajak, G., P. Clarenbach, W. Fischer, W. Haase, and E. Rüther. 1994. Zopiclone improves sleep quality and daytime well-being in insomniac patients: comparison with triazolam, flunitrazepam and placebo. International Clinical Psychopharmacology 9(4):251-261. Hedeker, D. R., and R. D. Gibbons. 1994. A random-effects ordinal regression model for multilevel analysis. Biometrics 50:933-944. Hedeker, D. R., and R. D. Gibbons. 1996. MIXOR: a computer program for mixed-effects ordinal regression analysis. Computer Methods and Programs in Biomedicine 49:157-176. Hedenbro, J. L., M. Ekelund, T. Aberg, and A. Lindblom. 1991. Oral sedation for diagnostic upper endoscopy. Endoscopy 23(1):8-10. Hegelbach-Feller, D. A., J. M. Tschopp, S. Christeller, and J. Fabre. 1988. Comparison of the short-acting benzodiazepines midazolam and triazolam with placebo. Arzneimittelforschung 38(3):387-392. Hemmelgarn, B., S. Suissa, A. Huang, J. F. Boivin, and G. Pinard. 1997. Benzodiazepine use and the risk of motor vehicle crash in the elderly. Journal of the American Medical Association 278(1):27-31. Hindmarch, I., N. Sherwood, and J. S. Kerr. 1993. Amnestic effects of triazolam and other hypnotics. Progress in Neuropsychopharmacology and Biological Psychiatry 17:407-413. Hukkinen, S. K., A. Varhe, K. T. Olkkola, and P. J. Neuvonen. 1995. Plasma concentrations of triazolam are increased by concomitant ingestion of grapefruit juice. Clinical Pharmacology and Therapeutics 58:127-131. Jacobsen, P. B., M. J. Massie, D. W. Kinne, and J. C. Holland. 1994. Hypnotic efficacy and safety of triazolam administered during the postoperative period. General Hospital Psychiatry 16(6):419-425.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data Jonas, J. M., B. S. Coleman, A. Q. Sheridan, and R. W. Kalinske. 1992. Comparative clinical profiles of triazolam versus other shorter-acting hypnotics. Journal of Clinical Psychiatry 53(Suppl.):19-31. Kales, A. et al. 1982. Quazepam and flurazepam: long-term use and extended withdrawal. Clinical Pharmacology and Therapeutics 32:781-788. Kales, A., E. O. Bixler, A. Vela-Bueno, C. R. Soldatos, D. E. Niklaus, and R. L. Manfredi. 1986. Comparison of short and long half-life benzodiazepine hypnotics: Triazolam and quazepam. Clinical Pharmacology and Therapeutics 40:378-386. Kales, A., A. N. Vgontza, and E. O. Bixler. 1996. A reassessment of triazolam. International Journal of Risk and Safety in Medicine 9:27. Kales, A., R. L. Manfredi, A. N. Vgontzas, E. O. Bixler, A. Vela-Bueno, and E. C. Fee. 1991. Rebound insomnia after only brief and intermittent use of rapidly eliminated benzodiazepines. Clinical Pharmacology Therapeutics 49:468-476. Klett, C. J. 1992. Review of triazolam data. Journal of Clinical Psychiatry 53(Suppl.):61-67. Kosuge, K., M. Nishimoto, M. Kimura, K. Umemura, M. Nakashima, and K. Ohashi. 1997. Enhanced effect of triazolam with diltiazem, British Journal of Clinical Pharmacology 43:367-372. Kroboth, P. D., R. J. Bertz, and R. B. Smith. 1993. Acute tolerance to triazolam during continuous and step infusions: estimation of the effect offset rate constant. Journal of Pharmacology and Experimental Therapy 264:1047-1055. Kroboth, P. D., J. W. McAuley, and C. L. Deny. 1995. Time-dependent sensitization to triazolam? An observation in three studies. Journal of Clinical Psychopharmacology 15:192-196. Krystal, J. H., A. Bennett, J. D. Bremner, S. Southwick, and D. S. Charney. 1995. Toward a cognitive neuroscience of dissociation and altered memory functions in post-traumatic stress disorder. In: Neurobiological and Clinical Consequences of Stress: From Normal Adaptation to PTSD, M. J. Friedman, D. S. Charney, and A. Y. Deutch, eds. New York: Raven Press. Krystal, J. H., D. N. Deutsch, and D. S. Charney. 1996. The biological basis of panic disorder. Journal of Clinical Psychiatry 57(Suppl. 10):23-31. Kuitunen, T. 1994. Drug and ethanol effects on the clinical test for drunkenness: single doses of ethanol, hypnotic drugs and antidepressant drugs. Pharmacology & Toxicology 75(2):91-98. Kupfer, D. J., and C. F. Reynolds. 1997. Current concepts: management of insomnia. New England Journal of Medicine 336(5):341-346. Kuribara, H., and T. Asahi. 1997. Assessment of the anxiolytic and amnesic effects of three benzodiazepines, diazepam, alprazolam and triazolam, by conflict and non-matching to sample tests in mice. Nihon Shinkei Seishin Yakurigaku Zasshi 17:1-6. Laughren, T. P., and H. Lee. 1992. Review of adverse event data in Upjohn sponsored clinical studies of Halcion (triazolam), NDA 17-892. Report to U.S. Food and Drug Administration, Rockville, Maryland.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data Laurent, J. P., M. Marigold, U. Humbel, and W. Haefely. 1983. Reduction by two benzodiazepines and pentobarbitone of the multiunit activity in substantia nigra, hippocampus, nucleus locus coeruleus and nucleus raphe dorsalis of encephale isole rats. Neuropharmacology 22(4):501-511. Lee, A., and M. Lader. 1988. Tolerance and rebound during and after short-term administration of quazepam, trizaolam and placebo to healthy human volunteers International Clinical Psychopharmacology 3(1):31-47. Lee, H. 1990. Addendum to the review and evaluation of clinical data for estazolam (NDA 19-080). U.S. Food and Drug Administration, Rockville, Maryland. Lee, H. 1996. FDA, Medical Officer Review of Protocol M/2100/0235. Study Report TR 9158- 95-028. U.S. Food and Drug Administration, Rockville, Maryland. Leppik, I.E., G. B. Roth-Schechter, G. W. Gray, et al. 1997. Double-blind, placebo-controlled comparison of zolpidem, triazolam, and temazepam in elderly patients with insomnia. Drug Development Research 40:230-238. Lobo, B. L., and W. L. Greene. 1997. Zolpidem: distinct from triazolam? Annals of Pharmacotherapy 31:625-632. Mamelak, M., A. Csima, and V. Price. 1990. The effects of a single night's dosing with triazolam on sleep the following night. Journal of Clinical Pharmacology 30(6):549-555. Mann, R., Y. Lis, and W. Spitzer. 1992a. A presentation of independent findings from the Value-Added Medical Products (VAMP). research database. Eighth International Conference on Pharmacoepidemiology, Minneapolis, Minnesota. Mann, R D., G. Hall, and J. Chukwujindu. 1992b. Research implications of computerized primary care. Postmarketing Surveillance 5:259-268. Mariano, J. P., and J. S. Gardner. 1988. Report to the FDA of medical events occurring in the Evaluation of Medications for Insomnia in Canada (EMIC). The Upjohn Company, Kalamazoo, Michigan. Marticello, D. 1992. Presentation to the Psychopharmacologic Drugs Advisory Committee. Transcript from Meeting No. 35, May 19, 1992. U.S. Food and Drug Administration, Rockville, Maryland. Martinez-Cano, H., A. Vela-Bueno, M. De Iceta, R. Pomalima, I. Martinez-Gras, and M. P. Sobrino. 1996. Benzodiazepine types in high versus therapeutic dose dependence. Addiction 91:1179-1186. Maud, M. C., S. Gianetti, L. Pugnetti, and A. C. Altamura. 1993. Quazepam versus triazolam in patients with sleep disorders: a double-blind study. International Journal of Clinical Pharmacology and Research 13(3):173-177. McAuley, J. W., I. J. Reynolds, F. J. Kroboth, R. B. Smith, and P. D. Kroboth. 1995. Orally administered progesterone enhances sensitivity to triazolam in post-menopausal women. Journal of Clinical Psychopharmacology 15:3-11 McClusky, H. Y., J. B. Milby, P. K. Switzer, V. Williams, and V. Wooten. 1991. Efficacy of behavioral versus triazolam treatment in persistent sleep-onsent insomnia. American Journal of Psychiatry 148(1):121-126. Medicines Control Agency. 1992. Letter to Upjohn announcing intention to revoke licenses for marketing triazolam. July 17. Medicines Control Agency, London, United Kingdom.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data Mellinger, G. D., M. B. Balter, and E. H. Uhlenhuth. 1985. Insomnia and its treatment: prevalence and correlates. Archives of General Psychiatry 42:225-232. Mendelson, W. B., and B. Jain. 1995. An assessment of short-acting hypnotics. Drug Safety 13:257-270. Mendelson, W. B., et al. 1995. Subjective versus objective tolerance during long term administration of triazolam. Clinical Drug Invest 10:276-279. Mendelson, W. B., C. Thompson, and T. Franko. 1996a. Adverse reactions to sedative/hypnotics: three years' experience. Sleep 19:702-706. Mendelson, W. B., et al. 1996b. The use of sedative/hypnotic medication and its correlation with falling down in the hospital. Sleep 19:698-701. Merlotti, L., T. Roehrs, F. Zorick, and T. Roth. 1991. Rebound insomnia: duration of use and individual differences. Journal of Clinical Psychopharmacology 11(6):368-373. Meyboom, R. H. B. 1992. The triazolam experience in 1979 in The Netherlands: A problem of signal generation and verification. In: Drug Epidemiology and Post-Marketing Surveillance, B. L. Strom and G. Velo, eds. New York: Plenum Press. Milgrom, P., F. C. Quarnstrom, A. Longley, and E. Libed. 1994. The efficacy and memory effects of oral triazolam premedication in highly anxious dental patients. Anesthesiology Progress 41(3):70-76. Miller, L. G., D. J. Greenblatt, D. R. Abernethy, H. Friedman, D. D. Luu, S. M. Paul, and R. I. Shader. 1988. Kinetics, brain uptake, and receptor binding characteristics of flurazepam and its metabolites. Psychopharmacology (Berl.) 94(3):386-91. Mitler, M. M., W. B. Seidel, J. Van den Hoed, D. J. Greenblatt, and W. C. Dement. 1984. Comparative hypnotic effects of flurazepam, triazolam, and placebo: a long-term simultaneous nighttime and daytime study. Journal of Clinical Psychopharmacology 4:2-16. Monti, J. M., P. Attali, D. Monti, A. Zipfel, B. de la Giclais, and P. L. Morselli. 1994. Zolpidem and rebound insomnia—a double-blind, controlled polysomnographic study in chronic insomniac patients. Pharmacopsychiatry 27(4):166-175. Morgan, P. J., R. Chapados, F. F. Chung, M. Gauthier, J. W. D. Knox, and J. Le Lorier. 1997. Evaluation of zolpidem, triazolam, and placebo as hypnotic drugs the night before surgery. Journal of Clinical Anesthesia 9:97-102. Mouret, J., D. Ruel, F. Maillard, and M. Bianchi. 1990. Zopiclone versus triazolam in insomniac geriatric patients: a specific increase in delta sleep with zopiclone. International Clinical Psychopharmacology 5(Suppl. 2): 47-55. Nakane, H., N. Shimizu, and T. Hori. 1994. Stress-induced norepinephrine release in the rat prefrontal cortex measured by microdialysis. American Journal of Physiology 267(6 Pt. 2):R1559-R1566. Oliveto, A. H., W. K. Bickel, J. B. Kamien, J. R. Hughes, and S. T. Higgins. 1994. Effects of diazepam and hydromorphone in triazolam-trained humans under a novel-response drug discrimination procedure. Psychopharmacology 114(3):417-423. Penetar, D. M., G. Belenky, J. J. Garrigan, and D. P. Redmond. 1989. Triazolam impairs learning and fails to improve sleep in a long-range aerial deployment. Aviation and Space Environment Medicine 60:594-598.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data Pikaar, N. A., M. Wedel, and R. J. Hermus. 1988. Influence of several factors on blood alcohol concentrations after drinking alcohol. Alcohol 23:289-297. Pinnock, C. A., D. Fell, P. C. Hunt, R. Miller, and G. Smith. 1985. A comparison of triazolam and diazepam as premedication agents for minor gynaecological surgery. Anaesthesia 40(4):324-328. Public Citizen. 1992. Citizen's petition to withdraw approval of triazolam (Halcion). Washington D.C.: Public Citizen. Ramsey-Williams, V. A. and D. B. Carter. 1996. Chronic triazolam and its withdrawal alters GABAA receptor subunit mRNA levels: an in situ hybridization study. Brain Research: Molecular Brain Research 43:132-140. Richelson, E., A. Nelson, and R. Neeper. 1991. Binding of benzodiazepines and some major metabolites at their sites in normal human frontal cortex in vitro. Journal of Pharmacology and Experimental Therapy 256:897-901. Robin, D. W., M. Lee, S. S. Hasan, and A. J. Wood. 1993. Triazolam in cirrhosis: pharmacokinetics and pharmacodynamics. Clinical Pharmacology and Therapeutics 54:630-637. Robin, D. W., S. S. Hasan, T. Edeki, M. J. Lichtenstein, R. G. Shiavi, and A. J. Wood. 1996. Increased baseline sway contributes to increased losses of balance in older people following triazolam. Journal of the American Geriatric Society 44:300-304. Roehrs, T., F. J. Zorick, J. M. Sicklesteel, R. M. Wittig, K. M. Hartse, and T. Roth. 1983. Effects of hypnotics on memory. Journal of Clinical Psychopharmacology 3:310-333. Roehrs, T., L. Merlotti, F. Zorick, and T. Roth. 1992. Rebound insomnia in normals and patients with insomnia after abrupt and tapered discontinuation. Psychopharmacology 108:67-71. Roger, M., P. Attali, and J. P. Coquelin. 1993. Multicenter, double-blind, controlled comparison of zolpidem and triazolam in elderly patients with insomnia. Clinical Therapy 15(1):127-136. Rosenberg, J., and F. Ahlstrom. 1994. Randomized, double-blind trial of zolpidem 10 mg verses triazolam 0.25 mg for treatment of insomnia in general practice. Scandinavian Journal of Primary Health Care 12:88-92. Roth, T., M. Kramer, and T. Lutz. 1977. The effects of triazolam (0.25 mg) on the sleep of insomniac subjects. Drugs and Experimental Clinical Research 1:271-277. Roth, T., K. M. Hartse, P. G. Saab, P. M. Piccione, and M. Kramer. 1980. The effects of flurazepam, lorazepam, and triazolam on sleep and memory. Psychopharmacology 70:231-237. Rothschild, A. J. 1992. Disinhibition, amnestic reactions, and other adverse reactions secondary to triazolam: a review of the literature. Journal of Clinical Psychiatry 53(Suppl.): 69-79. Rukstalis, M. R., and H. de Wit. 1995. Subjective effects of triazolam at three phases of the menstrual cycle. Clinical Pharmacology and Therapeutics 57(2):146. Rush, C. R., S. T. Higgins, J. R. Hughes, and W. K. Bickel. 1993. A comparison of the acute behavioral effects of triazolam and temazepam in normal volunteers. Psychopharmacology 112(4):407-414.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data Rush, C. R., S. T. Higgins, J. R. Hughes, and W. K. Bickel. 1994. Acute behavioral effects of triazolam and caffeine, alone and in combination, in humans. Experimental and Clinical Psychopharmacology 2(3):211-222. Saletu, B., P. Anderer, N. Brandstatter, R. Frey, J. Grunberger, G. Klosch, M. Mandl, T. Wetter, and J. Zeitlhofer. 1994. Insomnia in generalized anxiety disorder: polysomnographic, psychometric and clinical investigations before, during and after therapy with a long-versus a short-half-life benzodiazepine (quazepam versus triazolam). Neuropsychobiology 29:69-90. Sanger, D. J., and J. Benavides. 1993. Discriminative stimulus effects of omega (BZ) receptor ligands: correlation with in vivo inhibition of [3H]-flumazenil binding in different regions of the rat central nervous system. Psychopharmacology 111:315-322. Scharf, M. B. 1993. Feasibility of an every-other-night regimen in insomniac patients: subjective hypnotic effectiveness of quazepam, triazolam, and placebo. Journal of Clinical Psychiatry 54(1):33-38. Scharf, M. B., K. Fletcher, and J. P. Graham. 1988. Comparative amnestic effects of benzodiazepine hypnotic agents. Journal of Clinical Psychiatry 49:134-137. Scharf, M. B., B. A. Sachais, D. W. Mayleben, K. Fletcher, and S. W. Jennings. 1990. A polysomnographic comparison of temazepam 15 and 30 mg with triazolam 0.125 and 0.25 mg in chronic insomnia. Current Therapeutics Research 48:555-567. Schweitzer, P. K., G. Koshorek, M. J. Muehlbach, D. D. Morris, T. Roehrs, J. K. Walsh, and T. Roth. 1991. Effects of estazolam and triazolam on transient insomnia associated with phase-shifted sleep. Human Psychopharmacology 6:99-107. Seidel, W. F., S. A. Cohen, N. G. Gliwise, T. Roth, and W. C. Dement. 1986. Dose-related effects of triazolam and flurazepam on a circadian rhythm insomnia. Clinical Pharmacology and Therapeutics 40:314-320. Sethy, V. H., and D. W. Harris. 1982. Determination of biological activity of alprazolam, triazolam, and their metabolites. Journal of Pharmacology 34:115-116. Simson, P. E., and J. M. Weiss. 1989. Peripheral, but not local or intracerebroventricular, administration of benzodiazepines attenuates evoked activity of locus coeruleus neurons. Brain Research 490(2):236-242. Spinweber, C. L., and L. C. Johnson. 1982. Effects of triazolam (0.5 mg.) on sleep, performance, memory, and arousal threshold. Psychopharmacology 76:5-12. Staller, M. K. 1994. Economic effects of insomnia. Clinical Therapeutics 16(5):873-897. Stopperich, P. S., P. A. Moore, R. L. Finder, B. E. McGirl; and R. J. Weyant. 1993. Oral triazolam pretreatment for intravenous sedation. Anesthesia Prog 40(4):117-121. Thorpy, M. J., M. Snyder, F. S. Aloe, P. S. Ledereich, and K. E. Startz. 1992. Short-term triazolam use improves nocturnal sleep of narcoleptics. Sleep 15(3):212-216. Tsong, Y. 1992. Statistical comparison of ADE reporting rates between triazolam and temezepam. Memorandum to Branch Chief, Epidemiology Branch, Office of Epidemiology, U.S. Food and Drug Administration, Rockville, Maryland. The Upjohn Company. 1991. Integrated Summary of Safety. The Upjohn Company, Kalamazoo, Michigan.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data The Upjohn Company. 1992. Advisory Committee Brochure on Halcion Tablets, prepared for the Psychopharmacological Drugs Advisory Committee Meeting No. 35, May 18, 1992. The Upjohn Company, Kalamazoo, Michigan. U.S. Department of Health, Education, and Welfare. 1977. Guidelines for the Clinical Evaluation of Hypnotic Drugs. U.S. Department of Health, Education, and Welfare, Washington D.C. U.S. Food and Drug Administration. 1996. Report of the Halcion Task Force. U.S. Food and Drug Administration, Rockville, Maryland. van der Kroef, C. 1979. Reactions to triazolam. Lancet 2:526. Villikka, K., K. T. Kivisto, J. T. Backman, K. T. Olkkola, and P. J. Neuvonen. 1997. Triazolam is ineffective in patients taking rifampin. Clinical Pharmacology and Therapeutics 61:8-14. von Moltke, L. L., D. J. Greenblatt, J. S. Harmatz, S. X. Duan, L. M. Harrel, M. M. Contreau-Bibbo, G. A. Pritchard, C. E. Wright, and R. I. Shader. 1996. Triazolam biotransformation by human liver microsomes in vitro: effects of metabolic inhibitors and clinical confirmation of a predicted interaction with ketoconazole. Journal of Pharmacology and Experimental Therapy 276:370-379. Ware, J. C., J. K. Walsh, M. B. Scharf, T. Roehrs, T. Roth, and G. W. Vogel. 1997. Minimal rebound insomnia after treatment with 10-mg zolpidem. Clinical Neuropharmocology 20:116-125. Warot, D., P. Danjou, P. Douillet, P. Keane, and A. J. Puech. 1994. Cognitive impairments induced by triazolam in healthy volunteers: antagonism by a partial inverse agonist of benzodiazepine receptor. Therapie 49(1):23-26. Watanabe, H., M. Suzuki, O. Kanno, and H. Kazamatsuri. 1992. A case report of triazolam-induced delirious state while recording a polsomnography. Japanese Journal of Psychiatry and Neurology 46:1010. Wehli, L., R. Knusel, K. Schelldorfer, and S. Christeller. 1985. Comparison of midazolam and triazolam for residual effects. Arzneimittelforschung 35(11):1700-1704. Weingartner, H. J., F. Putnam, D. T. George, and P. Ragan. 1995a. Drug state-dependent autobiographical knowledge. Experimental and Clinical Psychopharmacology 3(3):304-307. Weingartner, H. J., K. Sirocco, V. Curran, and O. Wolkowitz. 1995b. Memory facilitation following the administration of the benzodiazepine triazolam. Experimental and Clinical Psychopharmacology 3(3):298-303. Weingartner, H. J., K. Sirocco, R. Rawlings, E. Joyce, and D. Hommer. 1995c. Dissociations in the expression of the sedative effects of triazolam. Psychopharmacology 119(1):27-33. Wesensten, N. J., T. J. Balkin, and G. L. Belenky. 1996. Effects of daytime administration of zolpidem and triazolam on performance. Aviation and Space Environment Medicine 67:115-120. Wright, C. E., T. A. Lasher-Sisson, R. C. Steenwyk, and C. N. Swanson. 1992. A pharmacokinetic evaluation of the combined administration of triazolam and fluoxetine . Pharmacotherapy 12:103-106.

OCR for page 97
Halcion: An Independent Assessment of Safety and Efficacy Data Wysowski, D. K., and D. Barash. 1991. Adverse behavioral reactions attributed to triazolam in the Food and Drug Administration's spontaneous reporting system. Archives of Internal Medicine 151:2003-2008. Yonezawa, K., Y. Sugawara, H. Onuki, J. Abe, T. Miura, E. Musya, F. Ishizawa, and I. Yamaguchi. 1994. New trend of hipnotics given to outpatients and their response after changing triazolam tablet from 0.25 mg to 0.125 mg. Japanese Journal of Hospital Pharmacy 20(4):309-314.