Treatment options for insomnia-pharmacodynamics of zolpidem extended-release to benefit next-day performance

Postgraduate Medicine

Volumn 120, Issue 3, 2008, Pages 161-171

  Bogan, Richard K ^a  

^a SleepMed Inc   (United States)

Author keywords

Insomnia treatment; Next day functioning; Nonbenzodiazepine hypnotic; Residual effects; Sleep maintenance insomnia

Indexed keywords

4 AMINOBUTYRIC ACID A RECEPTOR; ALCOHOL; ANTIHISTAMINIC AGENT; ESZOPICLONE; FLURAZEPAM; KAVA; PLACEBO; RAMELTEON; TEMAZEPAM; TRAZODONE; TRIAZOLAM; TRYPTOPHAN; VALERIAN; ZALEPLON; ZOLPIDEM; ZOPICLONE; BENZODIAZEPINE DERIVATIVE; HYPNOTIC SEDATIVE AGENT; PYRIDINE DERIVATIVE;

ALCOHOLISM; ARTICLE; BRAIN FUNCTION; BRAIN REGION; CLINICAL TRIAL; COGNITIVE THERAPY; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG MECHANISM; HANGOVER; HUMAN; INSOMNIA; LIVER CIRRHOSIS; NIGHT; PHARMACODYNAMICS; RISK; SEDATION; SLEEP; TABLET; VOLUNTEER; WAKEFULNESS; DELAYED RELEASE FORMULATION; DRUG ANTAGONISM; HALF LIFE TIME; REVIEW;

BENZODIAZEPINES; DELAYED-ACTION PREPARATIONS; HALF-LIFE; HUMANS; HYPNOTICS AND SEDATIVES; PYRIDINES; RECEPTORS, GABA-A; SLEEP INITIATION AND MAINTENANCE DISORDERS;

EID: 56149123504     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2008.09.1916     Document Type: Article

References (80)

1. Ancoli-Israel S, Roth T. Characteristics of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. 1. Sleep. 1999;22(suppl 2):S347-S353.
2. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111. (Pubitemid 35231066)
3. Drake CL, Roehrs T, Roth T. Insomnia causes, consequences, and therapeutics: an overview. Depress Anxiety. 2003;18(4):163-176. (Pubitemid 38056063)
4. Hohagen F, Kappler C, Schramm E, Riemann D, Weyerer S, Berger M. Sleep onset insomnia, sleep maintaining insomnia and insomnia with early morning awakening - temporal stability of subtypes in a longitudinal study on general practice attenders. Sleep. 1994;17(6):551-554. (Pubitemid 24317744)
5. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Washington. DC: American Psychiatric Association; 2002.
6. Walsh JK. Pharmacologic management of insomnia. J Clin Psychiatry. 2004;65(suppl 16):41-45.
7. Nissen C, Kloepfer C, Nofzinger EA, Feige B, Voderholzer U, Riemann D. Impaired sleep-related memory consolidation in primary insomnia - a pilot study. Sleep. 2006;29(8):1068-1073. (Pubitemid 44257385)
8. Varkevisser M, Kerkhof GA. Chronic insomnia and performance in a 24-h constant routine study. J Sleep Res. 2005;14(1):49-59. (Pubitemid 40396071)
9. Rosenthal LD, Mcixner RM. Psychological status and levels of sleepiness-alertness among patients with insomnia. CNS Spectr. 2003;8(2):114-118. (Pubitemid 36760164)
10. Lichstein KL, Means MK, Noe SL, Aguillard RN. Fatigue and sleep disorders. Behav Res Ther. 1997;35(8):733-740.
11. Mellinger GD, Balter MB, Uhlenhuth EH. Insomnia and its treatment. Prevalence and correlates. Arch Gen Psychiatry. 1985;42(2):225-232. (Pubitemid 15016111)
12. Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002;51(3):229-235. (Pubitemid 34219685)
13. Ohayon MM, Caulet M, Philip P, Guilleminault C, Priest RG. How sleep and mental disorders are related to complaints of daytime sleepiness. Arch Intern Med. 1997;157(22):2645-2652. (Pubitemid 27519985)
14. Walsh JK, Engelhardt CL. The direct economic costs of insomnia in the United States for 1995. Sleep. 1999;22(suppl 2):S386-S393.
15. Simon GE, VonKorff M. Prevalence, burden, and treatment of insomnia in primary care. Am J Psychiatry. 1997;154(10):1417-1423. (Pubitemid 27415610)
16. Gottlieb DJ, Punjabi NM, Newman AB, et al. Association of sleep time with diabetes mellitus and impaired glucose tolerance. Arch Intern Med. 2005;165(8):863-867. (Pubitemid 40563232)
17. Schwartz S, McDowell Anderson W, Cole SR, Cornoni-Huntley J, Hays JC, Blazer O. Insomnia and heart disease: a review of epidemiologic studies. J Psychosom Res. 1999;47(4):313-333.
18. Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005;66(10):1254-1269.
19. Ford DE, Kamerow DB. Epidemiologic study of sleep disturbances and psychiatric disorders. An opportunity for prevention? JAMA. 1989;262(11):1479- 1484. (Pubitemid 19220042)
20. Roth T. Prevalence, associated risks, and treatment patterns of insomnia. J Clin Psychiatry. 2005;66(suppl 9):10-13; quiz 42-43.
21. Stein MD, Friedmann PD. Disturbed sleep and its relationship to alcohol use. Subst Abus. 2005;26(1):1-13.
22. Roth T, Roehrs T, Zorick F, Conway W. Pharmacological effects of sedative-hypnotics, narcotic analgesics, and alcohol during sleep. Med Clin North Am. 1985;69(6):1281-1288. (Pubitemid 16199960)
23. Norström T, Ramstedt M. Mortality and population drinking: a review of the literature. Drug Alcohol Rev. 2005;24(6):537-547. (Pubitemid 43000460)
24. Ambien CR™ (zolpidem tartrate extended release) CIV [package insert], Bridgewater, NJ: sanofi-aventis. http://products.sanofi-aventis.us/ ambien-cr/ambiener.html. Acceessed July 2008.
25. Ambien™ (zolpidem tartrate) CIV [package insert]. Bridgewater, NJ: sanofi-aventis. http://products.sanofi-aventis.us/ambien/ambien.pdf. Accessed July 2008.
26. LUNESTA™ (eszopiclone) [package insert]. Marlborough, MA: Sepracor, Inc. http://www.lunesta.com.PostedApprovedLabelingText.pdf. Accessed July 2008.
27. Sonata® CIV (zaleplon) [package insert]. Bristol, TN: King Pharmaceuticals, Inc. http://www.kingpharm.com.kingpharm/uploads/pdf-inserts/ Sonata-PI-and-MedGuide.pdf. Accessed July 2008.
28. National Institutes of Health. National Institutes of Health State of the Science Conference statement on manifestations and management of chronic insomnia in adults. Sleep. 2005;28(9):1049-1057.
29. Sproule BA, Busto UE, Buckle C, Herrmann N, Bowles S. The use of non-prescription sleep products in the elderly. Int J Geriatr Psychiatry. 1999;14(10):851-857. (Pubitemid 29495546)
30. Winkelman J, Pies R. Current patterns and future directions in the treatment of insomnia. Ann Clin Psychiatry. 2005;17(1):31-40. (Pubitemid 40471682)
31. Leonard BE. Serotonin receptors and their function in sleep, anxiety disorders and depression. Psychother Psychosom. 1996;65(2):66-75. (Pubitemid 26095798)
32. Rozerem™ (ramelteon) [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc. http://www.rozerem.com/PI-1.aspx. Accessed July 2008.
33. Roth T, Seiden D, Sainati S, Wang-Weigand S, Zhang J, Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006;7(4):312-318. (Pubitemid 43792892)
34. Erman M, Seiden D, Zammit G, Sainati S, Zhang J. An efficacy, safety, and dose-response study of Ramelteon in patients with chronic primary insomnia. Sleep Med. 2006;7(1):17-24. (Pubitemid 43033540)
35. Turek FW, Gillette MU. Melatonin, sleep, and cireadian rhythms: a rationale for development of specific melatonin agonists. Sleep Med. 2004;5(6):523-532. (Pubitemid 39420030)
36. Ebert B, Wafford KA, Deacon S. Treating insomnia: current and investigational pharmacological approaches. Pharmacol Ther. 2006;112(3):612-629. (Pubitemid 44573490)
37. Kales A, Bixler EO, Soldatos CR, Vela-Bueno A, Jacoby J, Kales JD. Quazepam and flurazepam: long-term use and extended withdrawal. Clin Pharmacol Ther. 1982;32(6):781-788.
38. Tansella CZ, Tansella M, Lader M. A comparison of the clinical and psychological effects of diazepam and amylobarbitone in anxious patients. Br J Clin Pharmacol. 1979;7(6):605-611. (Pubitemid 9164593)
39. Kales A, Scharf MB, Kales JD, Soldatos CR. Rebound insomnia. A potential hazard following withdrawal of certain benzodiazepines, JAMA. 1979;241(16):1692-1695. (Pubitemid 9227988)
40. Monti JM, Attali P, Monti D, Zipfel A, de la Giclais B, Morselli PL. Zolpidem and rebound insomnia - a double-blind, controlled polysomnographic study in chronic insomniac patients. Pharmacopsychiatry. 1994;27(4):166-175. (Pubitemid 24214280)
41. Terzano MG, Rossi M, Palomba V, Smerieri A, Parrino L. New drugs for insomnia: comparative tolerability of zopiclone, zolpidem and zaleplon. Drug Saf. 2003;26(4):261-282. (Pubitemid 36363607)
42. Ramakrishnan K, Scheid DC. Treatment options for insomnia. Am Fam Physician. 2007;76(4):517-526. (Pubitemid 47347603)
43. Scharf M, Erman M, Rosenberg R, et al. A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia. Sleep. 2005;28(6):720-727. (Pubitemid 40798714)
44. Griffiths RR, Johnson MW. Relative abuse liability of hypnotic drugs: a conceptual framework and algorithm for differentiating among compounds. J Clin Psychiatry. 2005;66(suppl 9):31-41. (Pubitemid 43011561)
45. Malmivaara A, Heliovaara M, Knekt P, Reunanen A, Aromaa A. Risk factors for injurious falls leading to hospitalization or death in a cohort of 19,500 adults. Am J Epidemiol. 1993;138(6):384-394. (Pubitemid 23289291)
46. Allain H, Bentue-Ferrer D, Polard E, Akwa Y, Patat A. Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly: a comparative review. Drugs Aging. 2005;22(9):749-765.
47. Erman MK. Therapeutic options in the treatment of insomnia. J Clin Psychiatry. 2005;66(suppl 9):18-23; quiz 42-43. (Pubitemid 43011559)
48. Roth T, Roehrs TA. Issues in the use of benzodiazepine therapy. J Clin Psychiatry. 1992;53(suppl):14-18.
49. Nicholson AN. The use of short- and long-acting hypnotics in clinical medicine. Br J Clin Pharmacol. 1981;11(suppl 1):61S-69S. (Pubitemid 11098014)
50. Drover DR. Comparative pharmacokinetics and pharmacodynamics of short-acting hypnosedatives: zaleplon, zolpidem and zopiclone. Clin Pharmacokinet. 2004;43(4):227-238. (Pubitemid 38429303)
51. Johnson LC, Chernik DA. Sedative-hypnotics and human performance. Psychopharmacology (Berl). 1982;76(2):101-113.
52. Sanger DJ, Zivkovic B. Differential development of tolerance to the depressant effects of benzodiazepine and non-benzodiazepine agonists at the omega (BZ) modulatory sites of GABAA receptors. Neuropharmacology. 1992;31(7):693-700.
53. Saper CB, Chou TC, Scammell TE. The sleep switch: hypothalamic control of sleep and wakefulness. Trends Neurosci. 2001;24(12):726-731. (Pubitemid 33097540)
54. Rudolph U, Crestani F, Benke D, et al. Benzodiazepine actions mediated by specific gamma-aminobutyric acid(A) receptor subtypes. Nature. 1999;401(6755):796-800. (Pubitemid 129515840)
55. Gorenstein C, Gentil V. Residual and acute effects of flurazepam and triazolam in normal subjects. Psychopharmacology (Berl). 1983;80(4):376-379.
56. Muraoka M, Tada K, Nogami Y, Ishikawa K, Nagoya T. Residual effects of repeated administration of triazolam and nitrazepam in healthy volunteers. Neuropsychobiology. 1992;25(3).134-139.
57. Korpi ER, Mattila MJ, Wisden W, Luddens H. GABA(A)-receptor subtypes: clinical efficacy and selectivity of benzodiazepine site ligands. Ann Med. 1997;29(4):275-282. (Pubitemid 27399946)
58. Ashton H. Guidelines for the rational use of benzodiazepines. When and what to use. Drugs. 1994;48(1):25-40. (Pubitemid 24223938)
59. Vgontzas AN, Kales A, Bixler EO. Benzodiazepine side effects: role of pharmacokinetics and pharmacodynamics. Pharmacology. 1995;51(4):205-223.
60. Sanger DJ, Benavides J, Perrault G, et al. Recent developments in the behavioral pharmacology of benzodiazepine (omega) receptors: evidence for the functional significance of receptor subtypes. Neurosci Biobehav Rev. 1994;18(3):355-372. (Pubitemid 24258708)
61. Lydiard RB, Lankford DA, Seiden DJ, Landin R, Farber R, Walsh JK. Efficacy and tolerability of modified-release indiplon in elderly patients with chronic insomnia: results of a 2-week double-blind, placebo-controlled trial. J Clin Sleep Med. 2006;2(3):309-315. (Pubitemid 44299555)
62. Perrault G, Morel E, Sanger DJ, Zivkovic B. Differences in pharmacological profiles of a new generation of benzodiazepine and non-benzodiazepine hypnotics. Eur J Pharmacol. 1990;187(3):487-494. (Pubitemid 20357499)
63. Rosenberg R, Roth T, Scharf MB, Lankford DA, Farber R. Efficacy and tolerability of indiplon in transient insomnia. J Clin Sleep Med. 2007;3(4):374-379. (Pubitemid 46984034)
64. Salva P, Costa J. Clinical pharmacokinetics and pharmacodynamics of zolpidem. Therapeutic implications. Clin Pharmacokinet. 1995;29(3):142-153.
65. Walsh JK, Moscovitch A, Burke J, Farber R, Roth T. Efficacy and tolerability of indiplon in older adults with primary insomnia. Sleep Med. 2007;8(7-8):753-759. (Pubitemid 47535006)
66. Savić MM, Obradović DI, Ugresić ND, Bokonjić DR. Memory effects of benzodiazepines: memory stages and types versus binding-site subtypes. Neural Plast. 2005;12(4):289-298. (Pubitemid 43072005)
67. Lieberman JA. Update on the safety considerations in the management of insomnia with hypnotics: incorporating modified-release formulations into primary care. Prim Care Companion J Clin Psychiatry. 2007;9(1):25-31. (Pubitemid 46280275)
68. Besset A, Tafti M, Villemin E, Borderies P, Billiard M. Effects of zolpidem on the architecture and cyclical structure of sleep in poor sleepers. Drugs Exp Clin Res. 1995;21(4):161-169.
69. Roth T, Roehrs T, Vogel G. Zolpidem in the treatment of transient insomnia: a double-blind, randomized comparison with placebo. Sleep. 1995;18(4):246-251.
70. Scharf MB, Roth T, Vogel GW, Walsh JK. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry. 1994;55(5):192-199. (Pubitemid 24184828)
71. Uchimura N, Nakajima T, Hayash K, et al. Effect of zolpidem on sleep architecture and its next-morning residual effect in insomniac patients: a randomized crossover comparative study with brotizolam. Prog Neuropsychopharmacol Biol Psychiatry. 2006;30(1):22-29. (Pubitemid 43024072)
72. Erman M, Young T, Patel S, Neubauer D. The role of modified-release formulations in hypnotic therapy for insomnia. CNS Spectr. 2005;10(6):1-16. (Pubitemid 41232547)
73. Weinling E, McDougall S, Andre F, Bianchetti G, Dubrue C. Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. Fundam Clin Pharmacol. 2006;20(4):397-403. (Pubitemid 44034329)
74. Hindmarch I, Stanley N, Legangneux E, Emegbo S. Zolpidem modified-release 12.5 mg improves measures of sleep continuity in a model of sleep disturbance (traffic noise) compared with standard zolpidem 10 mg. Pharmacotherapy. 2005;25:1504.
75. Blin O, Micallef J, Audebert C, Legangneux E. A double-blind, placebo-and flurazepam-controlled investigation of the residual psychomotor and cognitive effects of modified release zolpidem in young healthy volunteers. J Clin Psychopharmacol. 2006;26(3):284-289. (Pubitemid 43804620)
76. Hindrnarch I, Legangneux E, Stanley N, Emegbo S, Dawson J. A double-blind, placebo-controlled investigation of the residual psychomotor and cognitive effects of zolpidem-MR in healthy elderly volunteers. Br J Clin Pharmacol. 2006;62(5):538-545. (Pubitemid 44571574)
77. Roth T, Soubrane C, Titeux L, Walsh JK. Efficacy and safety of zolpidem-MR: a double-blind, placebo-controlled study in adults with primary insomnia. Sleep Med. 2006;7(5):397-406. (Pubitemid 44103494)
78. Walsh JK, Soubrane C, Roth T. Efficacy and safely of zolpidem extended release in elderly primary insomnia patients. Am J Geriatr Psychiatry, 2008;16(1):44-57.
79. Krystal AD, Erman M, Zammit GK, Soubrane C, Roth T. Long-term efficacy and safely of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sleep. 2008;31(1):79-90.
80. Sanna E, Busonero F, Talani G, et al. Comparison of the effects of zaleplon, zolpidem, and triazolam at various GABA(A) receptor subtypes. Eur J Pharmacol. 2002;451(2):103-110. (Pubitemid 35253948)