An Assessment of Short-Acting Hypnotics

Drug Safety - Tập 13 - Trang 257-270 - 2012
Wallace B. Mendelson1, Bharat Jain1
1Sleep Disorders Center, Department of Neurology, The Cleveland Clinic Foundation, Cleveland, USA

Tóm tắt

Insomnia, the experience of poor quality or quantity of sleep, is a very common complaint. Approximately 65 million adults (36% of the American population) complain of poor sleep, and of this group, 25% have insomnia on a chronic basis. These chronic insomniacs not only report higher rates of difficulty with concentration, memory and the ability to cope with minor irritations but also have 2.5 times more fatigue-related automobile accidents than do good sleepers. Despite its ubiquity, insomnia is often either untreated or inadequately treated. Short-acting hypnotics are advocated for transient insomnia, which lasts less than 3 weeks, and in patients with chronic insomnia as an adjunctive treatment where nonpharmacological treatment is not sufficient to alleviate insomnia and the related daytime detrimental effects. The putative adverse effects of hypnotics must be weighed against the severe health effects caused by continued sleep impairment. If hypnotic agents are used, they should be taken nightly only for brief use, or intermittently in longer term use. Benzodiazepines, Zolpidem and zopiclone (in countries where the latter is available) remain the recommended hypnotic agents, although in the past few years there has been much criticism in lay magazines and on television about the use of benzodiazepines. However, this review of the efficacy and tolerability data of the short-acting hypnotics suggests that triazolam is comparable with other short-acting hypnotics at equipotent doses while taking into consideration that for every hypnotic, different study populations display different degrees of efficacy. In addition, contrary to previous suggestions that such adverse effects as rebound insomnia and anterograde amnesia are unique to triazolam, hypnotically equivalent doses of triazolam have not been shown to produce these effects more frequently than other short-acting hypnotics. The newer nonbenzodiazepine hypnotics seem to be equally efficacious as the short-acting benzodiazepines; whether they will truly have a better adverse effect profile will be determined as more clinical experience accumulates. Despite the availability, relative safety and efficacy of these newer hypnotic agents, they should not be perceived as the sole treatment for insomnia and should be used in conjunction with nonpharmacological techniques (such as adherence to good sleep hygiene, sleep restriction, stimulus control and biofeedback therapy).

Tài liệu tham khảo

Sleep in America. National Sleep Foundation. Los Angeles: Gallup Organization, Inc. 1991 National Institutes of Health Consensus Development Conference Statement: the treatment of sleep disorders of older people, March 26–28, 1990. Sleep 1991; 14 (2): 169-77 Ford DE, Kamerow DB. Epidemiologic study of sleep disturbances and psychiatric disorders. An opportunity for prevention? JAMA 1989; 262: 1479 Consensus conference. Drugs and insomnia: the use of medications to promote sleep. JAMA 1984; 251: 2410–4 Hishikawa Y. Appropriate use of benzodiazepines in insomnia; clinical update. J Clin Psychiatry 1991; 52: 10–3 Scharf MB. Feasibility of an every-other-night regimen in insomniac patients: subjective hypnotic effectiveness of quazepam, triazolam, and placebo. J Clin Psychiatry 1993; 54(1): 33–8 Breimer DD. Pharmacokinetics of methohexitone following intravenous infusion in humans. Br J Anaesth 1976; 48: 643–9 Breimer DD, Honhoff C, Zilly W, et al. Pharmacokinetics of hexobarbitol in man after intravenous infusion. J Pharmacokinet Biopharm 1977; 3: 1–11 Breimer DD, DeBoer AG. Pharmacokinetics and relative bio-availability of heptabarbitol and heptabarbitol sodium in man after oral administration. Eur J Clin Pharmacol 1975; 9: 169–78 Greenblatt DJ. Benzodiazepine hypnotics: sorting the pharmacological facts. J Clin Psychiatry 1991; 52 Suppl.: 4–10 McInnes GT, Bunting EA, Ings RMJ, et al. Pharmacokinetics and pharmacodynamics following single and repeated nightly administration of loprazolam, a new benzodiazepine hypnotic. Br J Clin Pharmacol 1985; 19: 649–56 Pierce DM, Franklin RA, Harry TVA, et al. Pharmacodynamic correlates of modified absorption: studies with lormetazepam. Br J Clin Pharmacol 1984; 18: 31–5 Breimer DD, Ketelaars HCJ, Van Rossum JM. The determination of chloral hydrate, trichloroethanol, and trichloroacetic acid in blood and urine, employing dead-space analysis. J Chromatogr 1974; 88: 55–63 Alvan G, Lindgren JE, Bogentoft C, et al. Plasma kinetics of methaqualone in man after single oral doses. Eur J Clin Pharmacol 1973; 6: 187–90 Curry SH, Riddall D, Gordon JS, et al. Disposition of glutethimide in man. Clin Pharmacol Ther 1971; 12: 849–57 Langtry HD, Benfield P. Zolpidem: a review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential. Drugs 1990; 40: 291–313 Goa K, Heel R. Zopiclone: a review of pharmacodynamic and pharmacokinetic properties and therapeutic efficacy as an hypnotic. Drugs 1986; 32: 48–65 Reynolds JEF, editor. Martindale: the extra pharmacopoeia. 29th ed. London: The Pharmaceutical Press; 1989: 717, 747-49, 775 Roth T, Roehrs TA. Issues in the use of benzodiazepine therapy. J Clin Psychopharmacol 1992; 53 Suppl.: 14–8 Bixler EO, Kales A, Brubaker BH, et al. Adverse reactions to benzodiazepine hypnotics: spontaneous reporting system. Pharmacology 1987; 35: 286–300 Wysowski DK, Baum C. Outpatient use of prescription sedative-hypnotic drugs in the United States, 1970 through 1989. Arch Intern Med 1992; 152: 1779–83 Blanchard JC, Boireau A, Garrett C, et al. In vitro and in vivo inhibition by zopiclone of benzodiazepine binding to rodent brain receptors. Life Sci 1979; 24: 2417–20 Perrault G, Morel E, Sanger DJ, et al. Lack of tolerance and physical dependence upon repeated treatment with the novel hypnotic Zolpidem. J Pharmacol Exp Ther 1992; 263(1): 298–303 Kim YD, Zhuang HY, Tsutsumi M, et al. Comparison of the effect of zopiclone and brotizolam on sleep EEG by quantitative evaluation in healthy young women. Sleep 1993; 16(7): 655–61 Jovanovic UJ, Dreyfus JF. Polygraphical sleep recordings in insomniac patients under zopiclone or nitrazepam. Int Pharmacopsychiatry 1982; 17 Suppl. 2: 136–45 Wright NA, Belyavin A, Borland RG, et al. Modulation of delta activity by hypnotics in middle-aged subjects: studies with a benzodiazepine (flurazepam) and a Cyclopyrrolone (zopiclone). Sleep 1986; 9: 348–52 Mamelak M, Scina A, Price V. Effects of zopiclone on the sleep of chronic insomniacs. Int Pharmacopsychiatry 1982; 17 Suppl. 2: 156–64 Scharf MB, Mayleben DW, Kaffeman M, et al. Dose response effects of Zolpidem in normal geriatric subjects. J Clin Psychiatry 1991; 52(2): 77–83 Blois R, Gaillard JM, Attali P, et al. Effect of Zolpidem on sleep in healthy subjects: a placebo-controlled trial with Polysomnographic recordings. Clin Ther 1993; 15(5): 797–809 Tada K, Sato Y, Sakai T, et al. Effects of zopiclone, triazolam, and nitrazepam on standing steadiness. Neuropsychobiology 1994; 29(1): 17–22 Fairweather DB, Kerr JS, Hindmarch I. The effects of acute and repeated doses of Zolpidem on subjective sleep, psychomotor performance and cognitive function in elderly volunteers. Eur J Clin Pharmacol 1992; 43(6): 597–601 Dehlin O, Rundgren A, Borjesson L, et al. Zopiclone to geriatric patients. A parallel double-blind dose-response clinical trial of zopiclone as a hypnotic to geriatric patients: a study in a geriatric hospital. Pharmacology 1983; 27 Suppl.: 173–8 Mizuki Y, Hirano H, Miyoshi A, et al. Residual effects of zopiclone on subsequent daytime functions in normal humans. Hum Psychopharmacol 1987; 2: 119–26 Thenot JP, Hermann P, Durand A, et al. Pharmacokinetics and metabolism of Zolpidem in various animal species and in humans. In: Sauvanet JP, Langer SZ, Morselli PL, editors. Imidazopyridines in sleep disorders. New York: Raven Press, 1988: 139–53 Gaillot J, Heusse D, Houghton GW, et al. Pharmacokinetics and metabolism of zopiclone. Pharmacology 1983; 27 Suppl. 2: 76–91 Mendelson WB. Human sleep: research and clinical care. New York: Plenum Press, 1987: 1–436 Zolpidem for insomnia. Med Lett Drugs Ther 1993; 35: 35-6 Monti JM. Effect of Zolpidem on sleep in insomniac patients. Eur J Clin Pharmacol 1989; 36: 461–6 Kryger MH, Steljes D, Pouliot Z, et al. Subjective versus objective evaluation of hypnotic efficacy: experience with Zolpidem. Sleep 1991; 14: 399–407 Roger M, Attali P, Coquelin JP. Multicenter, double-blind, controlled comparison of Zolpidem and triazolam in elderly patients with insomnia. Clin Ther 1993; 15: 127–36 Morgan PJ, Chapados R, Chung FT, et al. Efficacy of Zolpidem in patients with transient insomnia on the night before elective surgery [abstract]. Founding Congress of World Federation of Sleep Research Societies. 1991; Cannes, 21-5 Steens RD, Pouliot Z, Millar TW, et al. Effects of Zolpidem and triazolam on sleep and respiration in mild to moderate chronic obstructive pulmonary diseases. Sleep 1993; 16(4): 318–26 Rosenberg J, Ahlstrom F. Randomized, double blind trial of Zolpidem 10mg versus triazolam 0.25mg for treatment of insomnia in general practice. Scand J Prim Health Care 1994; 12(2): 88–92 Elie R, Prenay M, Le Morvan P, et al. Efficacy and safety of zopiclone and triazolam in the treatment of geriatric insomniacs. Int Clin Psychopharmacol 1990; 5 Suppl. 2: 39–46 Mouret J, Ruel D, Maillard P, et al. Zopiclone versus triazolam in insomniac geriatric patients: a specific increase in delta sleep with zopiclone. Int Clin Psychopharmacol 1990; 5 Suppl. 2: 47–55 Lamphere JK, Roehrs TA, Zorick FJ, et al. The dose effects of zopiclone. Hum Psychopharmacol 1989; 4: 41–6 Venter CP, Joubert PH, Stahmer SD, et al. Zopiclone compared to triazolam in insomnia in geriatric patients. Curr Ther Res 1986; 40: 1062–8 Chaudoir PJ, Jarvie NC, Wilcox GJ. The acceptability of a non-benzodiazepine hypnotic (zopiclone) in general practice. J Int Med Res 1983; 11: 333–7 Hayoun G, Bagot C. Comparative efficacy and safety of triazolam and zopiclone in insomniacs seen in general practice. Curr Ther Res 1989; 46: 1236–44 Klett JC. Review of triazolam data. J Clin Psychiatry 1992; 53(12): 61–7 Palminteri R, Narbonne G. Safety profile of Zolpidem. In: Sauvanet JP, Langer SZ, Morselli PL, editors. Imidazopyridines in sleep disorders. New York: Raven Press, 1988: 351–61 Allain H, Delahaye C, Le Coz F, et al. Postmarketing surveillance of zopiclone in insomnia: analysis of 20,513 cases. Sleep 1991; 14: 408–13 Roehrs T, Kribbs N, Zorick F, et al. Hypnotic residual effects of benzodiazepines with repeated administration. Sleep 1986; 9: 309–16 Roehrs T, Zorick F, Wittig R, et al. Efficacy of a reduced triazolam dose in elderly insomniacs. Neurobiol Aging 1985; 6: 293–6 Borbely AA, Youmbi-Balderer G, Jaggi-Schwartz K. Zolpidem (10mg and 20mg): hypnotic action and residual effects after a single bedtime dose. In Sauvanet JP, Langer SZ, Morselli PL, editors. Imidazopyridines in sleep disorders. New York: Raven Press, 1988 Lilie JK, Lahmeyer HW, Beizer LJ. Effect of Zolpidem in cognitive functioning and mood in insomniacs. Sleep Res 1989; 18: 12 Billiard M, Besset A, de Lustrac C, et al. Dose-response effects of zopiclone on night sleep and on nighttime and daytime functioning. Sleep 1987; 10 Suppl. 1: 27–34 Kales A, Soldatos CR, Bixler EO, et al. Rebound insomnia and rebound anxiety: a review. Pharmacology 1983; 24: 121–37 Mamelak M, Csima A, Price V. The effects of a nights’s dosing with triazolam on sleep the following night. J Clin Pharmacol 1990; 30: 549–55 Merlotti L, Roehrs T, Zorick F, et al. Rebound insomnia: duration of use and individual differences. J Clin Psychopharmacol 1991; 11: 368–73 Lader M, Frcka G. Subjective effects during administration and on discontinuation of zopiclone and temazepam in normal subjects. Pharmacopsychiatry 1987; 20: 67–71 Greenblatt DJ, Harmatz JS, Zinny MA, et al. Effect of gradual withdrawal on the rebound sleep disorder after discontinuation of triazolam. N Engl J Med 1987; 317: 722–8 Godtlibsen OB, Dreyfus JF. Effect of 7.5mg zopiclone on sleep pattern in normal subjects. Waking Sleeping 1980; 4: 319–25 Dorian P, Sellers EM, Kaplan H, et al. Evaluation of zopiclone physical dependence liability in normal volunteers. Int Clin Psychopharmacol 1982; 17 Suppl. 2: 228–34 Fleming JA, McClure DJ, Mayes C, et al. A comparison of the efficacy, safety and withdrawal effects of zopiclone and triazolam in the treatment of insomnia. Int Clin Psychopharmacol 1990; 5 Suppl. 2: 29–38 Tan TL, Bixler EO, Kales A, et al. Early morning insomnia, daytime anxiety and organic mental disorder associated with triazolam. J Fam Pract 1985; 20: 592–4 Kales A, Bixler EO, Vela-Bueno A, et al. Comparison of short and long half-life hypnotics: triazolom and quazepam. Clin Pharmacol Ther 1986; 40(4): 378–86 Roehrs T, Zovick F, Witting R, et al. Efficacy of a reduced triazolam dose in the elderly. Neurobiol Aging 1985; 6: 293–6 Roth T, Hartse KM, Saab PG, et al. The effects of flurazepam, lorazepam and triazolam on sleep and memory. Psychophar-macology 1980; 70: 231–7 Subhan Z, Hindmarch I. Effects of zopiclone and benzodiazepine hypnotics on search in short-term memory. Neuropsychobiology 1984; 12: 244–8 Curran HV. Tranquillizing memories: a review of the effects of benzodiazepines on human memory. Biol Psychol 1986; 23: 179–213 Greenblatt DJ, Harmatz JS, Engelhardt N, et al. Pharmacokinetic determinants of dynamic differences among three benzodiazepine hypnotics: flurazepam, temazepam and triazolam. Arch Gen Psychiatry 1989; 46: 326–32 Weingartner HJ, Eckardt MJ, Hommer DW, et al. Specificity of memory impairment with triazolam use. Lancet 1991; 338: 883–4 Roehrs T, Zorick F, Sicklesteel J, et al. Effects of hypnotics on memory. J Clin Psychopharmacol 1983; 3: 310–3 Hindmarch I, Sherwood N, Kerr JS. Amnesic effects of triazolam and other hypnotics. Prog Neuropsychopharmacol Biol Psychiatry 1993; 17: 407–13 Warot D, Bensimon G, Danjou PH, et al. Comparative effects of zopiclone, triazolam and placebo on memory and psychomotor performance in healthy volunteers. Fundam Clin Pharmacol 1987; 1: 145–52 Trappier B, Bezeredi T. Triazolam intoxication [letter]. Can Med Assoc J 1982; 126: 893–4 Einarson TR, Yoder ES. Triazolam psychosis: a syndrome? Drug Intell Clin Pharm 1982; 16: 330 Patterson JF. Triazolam syndrome in the elderly. South Med J 1987; 80: 1425–6 Ansseau M, Pitchot W, Hansenne M, et al. Psychotic reactions to Zolpidem [letter]. Lancet 1992; 339: 809 Berry RB, Kouchi K, Bower J, et al. Triazolam in patients with obstructive sleep apnea. Am J Respir Crit Care Med 1995; 151: 450–4 Mendelson WB. Safety of short-acting benzodiazepine hypnotics in patients with impaired respiration [letter]. Am J Psychiatry 1991; 148(10): 1401 Bonnet MH, Dexter JR, Arand DL. The effect of triazolam on arousal and respiration in central sleep apnea patients. Sleep 1990; 13(1): 31–41 Cohn MA. Effects of Zolpidem, codeine phosphate and placebo on respiration. A double-blind, crossover study in volunteers. Drug Saf 1993; 9(4): 312–9 Quera-Salva MA, McCann C, Boudet J, et al. Effects of Zolpidem on sleep architecture, night time ventilation, daytime vigilance and performance in heavy snorers. Br J Clin Pharmacol 1994; 37(6): 539–43 McCann CC, Quera-Salva MA, Boudet J, et al. Effect of Zolpidem during sleep on ventilation and cardiovascular variables in normal subjects. Fundam Clin Pharmacol 1993; 7(6): 305–10 Cirignotta F, Mondini S, Zucconi M, et al. Controlled Polysomnographic study of the effects of benzodiazepine and non-benzodiazepine hypnotics (Zolpidem) in obstructive sleep apnea patients: preliminary results. In: Sauvanet JP, Langer SZ, Morselli PL, editors. Imidazopyridines in sleep disorders. New York: Raven Press, 1988: 165–73 Murciano D, Aubier M, Palacios S, et al. Comparison of Zolpidem, triazolam and flunitrazepam effects on arterial blood gases and control of breathing in patients with severe chronic obstructive pulmonary disease. Chest 1990; 97 Suppl.: 51S–2S Ranlov PJ, Nielsen SP. Effect of zopiclone and diazepam on ventilatory response in normal human subjects. Sleep 1987; 10 Suppl. 1: 40–7 Muir JF, DeFouilloy P, Broussier R, et al. Comparative study of the effects of zopiclone and placebo on respiratory function in patients with chronic obstructive respiratory insufficiency. Int Clin Psychopharmacol 1990; 5 Suppl.: 85–94 Inoue Y, Takata K, Ueda K, et al. Comparison of zopiclone and flurazepam on sleep apnea in the elderly. Jpn J Psychiatry Neurol 1991; 45: 924–5 Kales A, Kales J, Bixler EO, et al. Hypnotic efficacy of triazolam: sleep laboratory evaluation of intermediate-term effectiveness. J Clin Pharmacol 1976; 18: 302–9 Mitler MM, Seidel WF, Van Den Hoed J, et al. Comparative hypnotic effects of flurazepam, triazolam and placebo: a long-term simultaneous nighttime and daytime study. J Clin Psychopharmacol 1984; 4: 2–16 Pegram V, Hyde P, Linton P. Chronic use of triazolam: the effects on the sleep patterns of insomniacs. J Int Med Res 1980; 8: 224–31 Leibowitz M, Sunshine H. Long term efficacy and safety of triazolam and flurazepam. J Clin Pharmacol 1978; 18: 302–9 Schlich D, Ls’Heritier C, Coquelin JP, et al. Long term treatment of insomnia with Zolpidem: a multicenter general practitioner study of 107 patients. J Int Med Res 1991; 19: 271–9 Hertich AJ, Capwell R, Roy-Byrne PP. A case of psychosis and delirium following withdrawal from triazolam. J Clin Psychiatry 1987; 48: 168–9 Shaw SH, Curson H, Coquelin JP. A double blind, comparative study of Zolpidem and placebo in the treatment of insomnia in elderly psychiatric in-patients. J Int Med Res 1992; 20: 150–61 Fleming JAE, Bourgouin J, Hamilton P. A sleep laboratory evaluation of the long term efficacy of zopiclone. Can J Psychiatry 1988; 33: 103–7 Pecknold J, Wilson R, Le Morvan P. Long term efficacy and withdrawal of zopiclone: a sleep laboratory study. Int Clin Psychopharmacol 1990; 5 Suppl. 2: 57–67 Fleming JAE. Triazolam abuse. Can Med Assoc J 1983; 129: 324–5 Garnier R, Guerault E, Muzard D, et al. Acute Zolpidem poisoning — analysis of 344 cases. J Toxicol Clin Toxicol 1994; 32(4): 391–404 Guerault E, Garnier R, Efthymiou ML. Intoxication aigue voluntaire par la zopiclone: 239 cas [abstract]. Therapie 1992; 47: 223 Regouby Y, Delomez G, Tisserant A. PR prolongation during voluntary zopiclone intoxication. Therapie 1989; 44: 375–80 Lheureux P, Debailleul G, De Witte O, et al. Zolpidem intoxication mimicking narcotic overdose: response to flumazenil. Hum Exp Toxicol 1990; 9: 105–7 Ahmad Z, Herepath M, Ebden P. Diagnostic utility of flumazenil in coma with suspected poisoning. BMJ 1991; 302: 92 Griffiths RR, Lamb JL, Ator NA, et al. Relative abuse liability of triazolam: experimental assessment in animals and humans. Neurosci Behav Rev 1985; 9: 133–51 Evans SM, Funderburk FR, Griffiths RR. Zolpidem and triazolam in humans: behavioral and subjective effects and abuse liability. J Pharmacol Exp Ther 1990; 255: 1246–55 Boissl K, Dreyfus JF, Delmotte M. Studies on the dependence-inducing potential of zopiclone and triazolam. Pharmacology 1987; 27 Suppl. 2: 242–7 Snesil NR, editor. Redbook update (1994). Montvale, NJ: Medical Economics Data; 1993 Oswald I, Adam K. Sleep helps healing. BMJ 1984; 289: 1400–1