Therapeutic options for sleep-maintenance and sleep-onset insomnia

Pharmacotherapy

Volumn 27, Issue 1, 2007, Pages 89-110

  Morin, Anna K ^a   Jarvis, Courtney I ^a   Lynch, Ann M ^a  

^a MASSACHUSETTS COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

Author keywords

Antihistamines; Benzodiazepines; Herbal products; Insomnia; Melatonin; Nonbenzodiazepines; Nonpharmacologic therapies; Ramelteon; Trazodone

Indexed keywords

ANTIHISTAMINIC AGENT; BENZODIAZEPINE; BENZODIAZEPINE RECEPTOR STIMULATING AGENT; DIPHENHYDRAMINE; ESTAZOLAM; ESZOPICLONE; FLURAZEPAM; HERBACEOUS AGENT; HYPNOTIC SEDATIVE AGENT; INDIPLON; KAVA; KETOCONAZOLE; LORAZEPAM; MELATONIN; MELATONIN RECEPTOR AGONIST; NON PRESCRIPTION DRUG; PLACEBO; PROMETHAZINE; QUAZEPAM; RAMELTEON; TEMAZEPAM; TRAZODONE; TRIAZOLAM; TRYPTOPHAN; UNCLASSIFIED DRUG; UNINDEXED DRUG; VALERIAN; ZALEPLON; ZOLPIDEM;

ADULT; AGED; ALCOHOL CONSUMPTION; AMNESIA; ATAXIA; ATHEROSCLEROTIC PLAQUE; BEHAVIOR THERAPY; BLURRED VISION; CARDIOVASCULAR DISEASE; CHRONIC DISEASE; CLINICAL TRIAL; COGNITIVE DEFECT; COGNITIVE THERAPY; COMORBIDITY; CONFUSION; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DELIRIUM; DISEASE ASSOCIATION; DISEASE EXACERBATION; DISORIENTATION; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG APPROVAL; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FORMULATION; DRUG INTERMITTENT THERAPY; DRUG MEGADOSE; DRUG OVERDOSE; DRUG SAFETY; DRUG WITHDRAWAL; DRY EYE; ELECTROENCEPHALOGRAPHY; EOSINOPHILIA MYALGIA SYNDROME; EXCITABILITY; FATIGUE; FEMALE INFERTILITY; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; GENERALIZED ANXIETY DISORDER; HALLUCINATION; HANGOVER; HEADACHE; HEART ARRHYTHMIA; HEART MUSCLE CONDUCTION DISTURBANCE; HERBAL MEDICINE; HUMAN; HYPERGLYCEMIA; HYPOTENSION; HYPOTHERMIA; INSOMNIA; INTRAOCULAR PRESSURE; IRRITABILITY; ISCHEMIC HEART DISEASE; LIVER TOXICITY; MAJOR DEPRESSION; MEMORY DISORDER; MENTAL DISEASE; META ANALYSIS; MOOD CHANGE; NAUSEA; NONREM SLEEP; OBSESSION; OFF LABEL DRUG USE; OVULATION INHIBITION; PARESTHESIA; POLYSOMNOGRAPHY; PRIAPISM; PSYCHOMOTOR DISORDER; PSYCHOPHARMACOTHERAPY; PSYCHOSIS; PSYCHOTHERAPY; RANDOMIZED CONTROLLED TRIAL; RASH; RECOMMENDED DRUG DOSE; RELAXATION TRAINING; REM SLEEP; REVIEW; SEDATION; SEIZURE THRESHOLD; SELF MEDICATION; SIDE EFFECT; SINGLE DRUG DOSE; SLEEP DISORDER; SLEEP WAKING CYCLE; SOMNOLENCE; SYNCOPE; SYSTEMATIC REVIEW; TACHYCARDIA; TASTE DISCRIMINATION; TORSADE DES POINTES; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; URINE RETENTION; VOMITING; XEROSTOMIA;

ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; DRUGS, NON-PRESCRIPTION; HISTAMINE H1 ANTAGONISTS; HUMANS; HYPNOTICS AND SEDATIVES; PHYTOTHERAPY; RECEPTORS, MELATONIN; SLEEP INITIATION AND MAINTENANCE DISORDERS; TRAZODONE;

EID: 33846067655     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.27.1.89     Document Type: Review

References (133)

1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders-text revision: DSM-IV-TR, 4th ed. Washington, DC: American Psychiatric Publishing, Inc., 2000.
2. Walsh JK. Clinical and socioeconomic correlates of insomnia. J Clin Psychiatry 2004;65(suppl 18):13-19.
3. National Sleep Foundation. National sleep awareness week. Sleep facts and stats. Available from http://www. sleepfoundation.org/NSAW/ pk_sleepfacts.cfm. Accessed January 30, 2006.
4. National Sleep Foundation. 2005 sleep in America poll. Available from http://ww.sleepfoundation.org. Accessed February 9, 2006.
5. Mendelson WB, Roth T, Cassella J, et al. The treatment of chronic insomnia: drug indications, chronic use and liability: summary of a 2001 new clinical drug evaluation unit meeting symposium. Sleep Med Rev 2004;8:7-17.
6. Benca RM, Ancoli-Israel A, Moldofsky H. Special considerations in insomnia diagnosis and management: depressed, elderly, and chronic pain populations. J Clin Psychiatry 2004;65(suppl 8):26-35.
7. Sateia MJ, Pigeon WR. Identification and management of insomnia. Med Clin North Am 2004;88:567-96.
8. Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiatr Serv 2005;56:332-43.
9. Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract 2002;51:229-35.
10. Simon GE, VonKorff M. Prevalence, burden, and treatment of insomnia in primary care. Am J Psychiatry 1997;154:1417-23.
11. Leger D, Guilleminault C, Bader G, Levy E, Paillard M. Medical and socio-professional impact of insomnia. Sleep 2002;25:625-9.
12. Mellinger GD, Balter MB, Uhlenhuth EH. Insomnia and its treatment: prevalence and correlates. Arch Gen Psychiatry 1985;42:225-32.
13. Gillin JC. Are sleep disturbances risk factors for anxiety, depressive, and addictive disorders? Acta Psychiatr Scand Suppl 1998;393:39-43.
14. Ford DE, Cooper-Patrick L. Sleep disturbances and mood disorders: an epidemiologic perspective. Depress Anxiety 2001;14:3-6.
15. Leineweber C, Kecklund G, Janszky I, Akerstedt T, Orth-Gomer K. Poor sleep increases the prospective risk for recurrent events in middle-aged women with coronary disease. The Stockholm female coronary risk study. J Psychsom Res 2003;54:121-7.
16. Walsh JK, Muehlbach MJ, Lauter SA, Hilliker NA, Schweitzer PK. Effects of triazolam on sleep, daytime sleepiness, and morning stiffness in patients with rheumatoid arthritis. J Rheumatol 1996;23:245-52.
17. Ropper AH, Brown RH, eds. Sleep and its abnormalities. In: Adams and Victors' principles of neurology, 8th ed. New York: McGraw Hill Co, Inc., 2005:333-51.
18. Roth T, Ancoli-Israel S. Daytime consequences and correlates of insomnia in the United States: results of the 1991 national sleep foundation survey. II. Sleep 1999;22(suppl 2):S354-8.
19. Kuppermann M, Lubeck DP, Mazonson PD, et al. Sleep problems and their correlates in a working population. J Gen Intern Med 1995;10:25-32.
20. Zammit GK, Weiner J, Damato N, Sillup GP, McMillan CA. Quality of life in people with insomnia. Sleep 1999;22(suppl 2):S379-85.
21. Schubert CR, Cruickshanks KJ, Dalton DS, Klein BE, Klein R, Nondahl DM. Prevalence of sleep problems and quality of life in an older population. Sleep 2002;25:889-93.
22. Hatoum HT, King SX, Kania CM, Wong JM, Mendelson WB. Insomnia, health-related quality of life and healthcare resource consumption: a study of managed-care organization enrollees. Pharmacoeconomics 1998;14:629-37.
23. Silber MH. Chronic insomnia. N Engl J Med 2005;353: 803-10.
24. Roth T. Measuring treatment efficacy in insomnia. J Clin Psychiatry 2004;65(suppl 8):8-12.
25. Walsh JK, Schweitzer PK. Ten-year trends in the pharmacological treatment of insomnia. Sleep 1999;22: 371-5.
26. National Sleep Foundation. Survey of primary care physicians. Washington, DC: WB&A Market Research, 2000
27. Morin CM, Hauri PJ, Espie CA, et al. Nonpharmacologic treatment of chronic insomnia: an American academy of sleep medicine review. Sleep 1999;22:1134-56.
28. Jacobs GD, Pace-Schott EF, Stickgold R, Otto MW. Cognitive behavioral therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Arch Intern Med 2004;164;1888-96.
29. Stepanski EJ, Wyatt JK. Use of sleep hygiene in the treatment of insomnia. Sleep Med Rev 2003;7:215-25.
30. Smith MT, Perlis ML, Park A, et al. Comparative metaanalysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry 2002;159:5-11.
31. Montgomery P, Dennis J. A systematic review of non-pharmacological therapies for sleep problems later in life. Sleep Med Rev 2004;8:47-62.
32. Jansson M, Linton SJ. Cognitive-behavioral group therapy as an early intervention for insomnia: a randomized controlled trial. J Occup Rehabil 2005;15:177-90.
33. Edinger JD, Wohlgemuth WK, Radtke RA, et al. Cognitive behavioral therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA 2001;285:1856-64.
34. Morin CM. Cognitive-behavioral approaches to the treatment of insomnia. J Clin Psychiatry 2004;65(suppl 16):33-40.
35. Chesson AM, Anderson WM, Littner M. Practice parameters for the nonpharmacologic treatment of chronic insomnia: an American academy of sleep medicine report. Standards of practice committee of the American academy of sleep medicine. Sleep 1999;22:1-6.
36. Morin CM, Colecchi C, Stone J, Sood R, Brink D. Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial. JAMA 1999;281: 991-9.
37. Charney DS, Mihic SJ, Harris RA. Hypnotics and sedatives. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman and Gilman's the pharmacologic basis of therapeutics, 11th ed. New York, NY: McGraw-Hill, Inc., 2006;401-27.
38. A receptor subtypes. Curr Top Med Chem 2002;2:795-816.
39. Minier F, Sigel E. Positioning of the α-subunit isoforms confers a functional signature to γ-aminobutyric acid type A receptors. Proc Natl Acad Sci USA 2004;101:7769-74.
40. Takeda Pharmaceuticals America, Inc. Rozerem (ramelteon tablets) product information. Lincolnshire, IL; 2005.
41. Sepracor Inc. Lunesta (eszopiclone tablets) product information. Marlborough, MA; 2005.
42. Smith AJ, Alder L, Silk J, et al. Effect of α-subunit on allosteric modulation of ion channel function in stably expressed human recombinant γ-aminobutyric acid A receptors determined using 36Cl ion flux. Mol Pharmacol 2001;59:1108-18.
43. 1 subtype. Nat Neurosci 2000;3:587-92.
44. Walsh JK. Pharmacologic management of insomnia. J Clin Psychiatry 2004;65(suppl 16):41-5.
45. Nowell PD, Mazumadar S, Buysse DJ, Dew MA, Reynolds CF, Kupfer DJ. Benzodiazepines and zolpidem for chronic insomnia: a meta-analysis for treatment of efficacy. JAMA 1997;279:2170-7.
46. Holbrook AM, Crowther R, Lotter A, Cheng C, King D. Meta-analysis of benzodiazepine in the treatment of insomnia. Can Med Assoc J 2000;162:225-33.
47. Martinez HT, Serna CT. Short-term treatment with quazepam of insomnia in geriatric patients. Clin Ther 1982;5:174-8.
48. Caldwell JR. Short-term quazepam treatment in geriatric patients. Pharmatherapeutica 1982;3:278-82.
49. Roth TG, Roehrs TA, Koshorek GL, Greenblatt DJ, Rosenthal LD. Hypnotic effects of low doses of quazepam in older insomniacs. J Clin Psychopharmacol 1997;17:401-7.
50. Leppik IE, Roth-Schechter GB, Gray GW, Cohn MA, Owens D. Double-blind, placebo-controlled comparison of zolpidem, triazolam, and temazepam in elderly patients with insomnia. Drug Dev Res 1997;40:230-7.
51. Mamelak M, Csima A, Buck L, Price V. A comparative study on the effects of brotizolam and flurazepam on sleep and performance in the elderly. J Clin Psychophamacol 1989;9:260-7.
52. Johnson LC, Chernik DA, Hauri P. A multicenter 14-day study of flurazepam and midazolam in chronic insomniacs: general discussion and conclusions. J Clin Psychopharmacol 1990;10:S76-90.
53. Chouinard G. Issues in the clinical use of benzodiazepines: potency, withdrawal, and rebound. J Clin Psychiatry 2004;65(suppl 5):7-12.
54. Roth T, Hartse KM, Saab. PG, Piccone PM, Kramer M. The effects of flurazepam, lorazepam, and triazolam on sleep and memory. Psychopharmacology 1980;70:231-7.
55. Roehrs TA, Zorick GJ, Wittig RM, Roth T. Dose determinants of rebound insomnia. Br J Clin Pharmacol 1986;22:143-7.
56. Fleming JA, McClure DJ, Mayes C, Phillips R, Courgouin J. 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):29-37.
57. Kales A, Manfredi RL, Vgontzas AN, Bixler EO, Vela-Bueno A, Fee EC. Rebound insomnia after only brief and intermittent use of rapidly eliminated benzodiazepines. Clin Pharmacol Ther 1991;49:468-76.
58. Roehrs T, Kribbs N, Zorick F, Roth T. Hypnotic residual effects of benzodiazepines with repeated administration. Sleep 1986;9:309-16.
59. Sanger DJ. The pharmacology and mechanism of action of new generation, non-benzodiazepine hypnotic agents. CNS Drugs 2004;18(suppl 1):9-15.
60. 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: 261-82.
61. A receptor subtypes. Eur J Pharmacol 2002;451:103-10.
62. Sanofi-Synthelabo, Inc. Ambien (zolpidem) product information. New York, NY; 2004.
63. Lee YJ. Overview of the therapeutic management of insomnia with zolpidem. CNS Drugs 2004;18(suppl 1):17-23.
64. Scharf MB, Roth T, Vogel GW, Walsh K. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry 1994;55:192-9.
65. Monti JM, Monti D, Estevez F, et al. Sleep in patients with chronic primary insomnia during long-term zolpidem administration after its withdrawal. Int Clin Psychopharmacol 1996;11:225-63.
66. Walsh K, Erman M, Erwin CW, et al. Subjective hypnotic efficacy of trazodone and zolpidem in DSM-III-R primary insomnia. Hum Psychopharmacol 1998;13:191-8.
67. Tsutsi S, for the Zolpidem Study Group. Double-blind comparative study of zolpidem versus zopiclone in the treatment of chronic primary insomnia. J Int Med Res 2001;29:163-77.
68. Lahmeyer H, Wilcox CS, Kann J, et al. Subjective efficacy of zolpidem in outpatients with chronic insomnia. Clin Drugs Invest 1997;13:134-44.
69. Ware JC, Walsk JK, Scharf MB, Roehrs T, Roth T, Vogel GW. Minimal rebound insomnia after treatment with 10-mg zolpidem. Clin Neuropharmacol 1997;20:116-25.
70. Roth T, Roehrs T, Vogel G. Zolpidem in the treatment of transient insomnia: a double-blind randomized comparison with placebo. Sleep 1995;18:246-51.
71. Fry J, Scharf M, Mangano R, Fuijimori M, for the Zaleplon Clinical Study Group. Zaleplon improves sleep without producing rebound effects in outpatients with insomnia. Int Clin Psychopharmacol 2002;15:141-52.
72. Elie R, Ruther E, Farr I, Emilien G, Salinas E, for the Zaleplon Clinical Study Group. Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. J Clin Psychiatry 1999; 60:536-44.
73. Ancoli-Israel S, Walsh JK, Mangano RM, Fujimori M. Zaleplon, a novel nonbenzodiazepine hypnotic, effectively treats insomnia in elderly patients without causing rebound effects. Prim Care Companion J Clin Psychiatry 1999;1:114-20.
74. Hajak G, Cluydts R, Declerck A, et al. Continuous versus non-nightly use of zolpidem in chronic insomnia: results of a large-scale, double-blind, randomized, outpatient study. Int Clin Pschyopharmacol 2002;17:9-17.
75. Cluydts R, Peeters K, de Bouyalsky I, et al. Comparison of continuous versus intermittent administration of zolpidem in chronic insomniacs: a double-blind, randomized pilot study. J Int Med Res 1998;26:13-24.
76. Allain H, Arbus L, Schuck S, et al. Efficacy and safety of zolpidem administered as needed in primary insomnia: results of a double blind placebo-controlled study. Clin Drug Invest 2001;21:391-400.
77. Walsh JK, Roth T, Randazzo A, et al. Eight weeks of non-nightly use of zolpidem for primary insomnia. Sleep 200;23:1087-96.
78. Ganzoni E, Santoni J, Chevillard V, et al. Zolpidem in insomnia: a 3-year post-marketing surveillance study in Switzerland. J Int Med Res 1995;23:61-73.
79. Sanofi-Synthelabo, Inc. Ambien CR (zolpidem extended-release) product information. New York; 2005.
80. Wyeth Pharmaceutics, Inc. Sonata (zaleplon capsules) product information. Philadelphia, PA; 2003.
81. Walsh JK, Vogel GW, Scharf M, et al. A 5-week, polysomnographic assessment of zaleplon 10 mg for the treatment of primary insomnia. Sleep Med 2000;1:41-9.
82. Troy SM, Lucki I, Unruh MA, et al. Comparison of the effects of zaleplon, zolpidem, and triazolam on memory, learning, and psychomotor performance. J Clin Psychopharmacol 2000;20:328-37.
83. Danjou P, Paty I, Fruncillo R, et al. A comparison of the residual effects of zaleplon and zolpidem following administration 5 to 2 hours before awakening. Br J Clin Pharmacol 1999;48:367-74.
84. Drake CL, Roehrs TA, Mangana RM, Roth T. Dose-response effects of zaleplon as compared with triazolam (0.25 mg) and placebo in chronic primary insomnia. Hum Psychopharm 2000;15:595-604.
85. Walsh JK, Pollack CP, Scharf MB, Schweitzer PK, Vogel GW. Lack of residual sedation following middle-of-the night zaleplon administration in sleep maintenance insomnia. Clin Neuropharmacol 2000;23:17-21.
86. Vermeeren A, Danjou PE, O'Hanlon JF. Residual effects of evening and middle-of-the night administration of zaleplon 10 mg and 20 mg on memory and actual driving performance. Hum Psychopharm Clin Exp 1998;13:98-107.
87. Beer B, Ieni JR, Wu WH, et al. A placebo-controlled evaluation of single, escalating doses of CL 284,847, a non-benzodiazepine hypnotic. J Clin Pharmacol 1994;34:335-44.
88. Hedner J, Yaeche R, Emilien G, Farr I, Salinas E, for the Zaleplon Clinical Investigator Study Group. Zaleplon shortens sleep latency and improves subjective sleep quality in elderly patients with insomnia. Int J Geriatr Psychiatry 2000;15:704-12.
89. Anonymous. Eszopiclone (Lunesta), a new hypnotic. Med Lett Drugs Ther 2005;47:17-19.
90. Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo controlled study in adults with chronic insomnia. Sleep 2003;26:793-9.
91. Roth T, Walsh JK, Krystal A, Wessel T, Roehrs TA. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med 2005;6:487-95.
92. Zammit GK, McNabb L, Caron J, Amato DA, Roth T. Efficacy and safety of eszopiclone across 6-weeks for primary insomnia. Curr Med Res Opin 2004;12:1979-91.
93. 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;28:720-7.
94. McCall WV, Rosenberg R, Caron J. Polysomnographic evaluation of the efficacy and safety of eszopiclone in elderly patients with chronic insomnia [abstr]. In: Program and abstracts of the 157th annual meeting of the American psychiatric association, New York, May 1-6, 2004. Arlington, VA: American Psychiatric Association.
95. Turek Fw, Gillette MU. Melatonin, sleep and circadian rhythms: rationale for development of specific melatonin agonists. Sleep Med 2004;5:523-32.
96. McGechan A, Wellington K. Ramelteon. CNS Drugs 2005;19:1057-65.
97. Roth T, Stubbs C, Walsh JK. Ramelteon (TAK-375), a selective MT1/MT2-receptor agonist, reduces latency to persistent sleep in a model of transient insomnia related to a novel sleep environment. Sleep 2005;28:303-7.
98. Zammit G, Schwartz H, Roth T. Phase III study of ramelteon in a first-night-effect model of transient insomnia. Presented at the world association of sleep medicine first congress, Berlin, Germany, October 15-18, 2005.
99. 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;7:17-24.
100. Zammit G, Roth T, Erman M, et al. Double-blind, placebo-controlled polysomnography and outpatient trial to evaluate the efficacy and safety of ramelteon in adult patients with chronic insomnia. Presented at the 158th annual meeting of the American psychiatric association, new research abstracts, Atlanta, GA, May 21-26, 2005.
101. Roth T, Seiden D, Zee P, et al. Phase III outpatient trial of ramelteon for the treatment of chronic insomnia in elderly patients [abstr]. J Am Geriatr Soc 2005;53(suppl 4):S25.
102. Roth T, Seiden D, Weigland S, et al. Phase III study to determine the efficacy of ramelteon in elderly patients with chronic insomnia. Presented at the 45th annual meeting of the new clinical drug evaluation unit (NCDEU), Boca Raton, FL, June 6-9, 2005.
103. Mendelson WB. A review of the evidence for the efficacy and safety of trazodone in insomnia. J Clin Psychiatry 2005;66:469-76.
104. Bristol-Myers Squibb Co. Desyrel (trazodone HCL) prescribing Information. Princeton, NJ; 2005.
105. Walsh JK, Erman M, Erwin CW, et al. Subjective hypnotic efficacy of trazodone and zolpldem in DSM-III-R primary insomnia. Hum Psychopharmacol 1998;13:191-8.
106. Montgomery I, Oswald I, Morgan K, et al. Trazodone enhances sleep in subjective quality but not in objective duration. Br J Pharmacol 1983;16:130-44.
107. Bayer AJ, Pathy MS, Ankier SI. Pharmacokinetic and pharmacodynamic characteristics of trazodone in the elderly. Br J Clin Pharmacol 1983;16:371-6.
108. Hathcock J. Dietary supplements: how are they used and regulated. J Nutr 2001;131:S1114-17.
109. Skidgel RA, Erdos EG. Histamine, bradykinin, and their antagonists. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman and Gilman's the pharmacologic basis of therapeutics, 11th ed. New York, NY: McGraw-Hill, 2006:629-51.
110. Bender BG, Berning S, Dudden R, Milgrom H, Tran ZV. Sedation and performance impairment of diphenhydramine and second-generation antihistamines: a meta-analysis. J Allergy Clin Immunol 2003;111:770-6.
111. Borbely AA, Youmbi-Balderer G. Effect of diphenhydramine on subjective sleep parameters and on motor activity during bedtime. J Clin Pharmacol 1988;26:392-6.
112. Kudo Y, Kurihara M. Clinical evaluation of diphenhydramine hydrochloride for the treatment of insomnia in psychiatric patients: a double-blind study. J Clin Pharmacol 1990;30:1041-8.
113. Rickels K, Morris RJ, Newman H, et al. Diphenhydramine in insomniac family practice patients: a double-blind study. J Clin Pharmacol 1983;23:234-42.
114. 1 antihistamines. J Clin Psychopharmacol 2002;22:511-15.
115. Gyllenhaal C, Merritt SL, Peterson SD, et al. Efficacy and safety of herbal stimulants and sedatives in sleep disorders. Sleep Med Rev 2000;4:229-51.
116. Brzezinski A, Vangel MG, Wurtman RJ, et al. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev 2005;9:41-50.
117. Kayumov L, Brown G, Jindal R, et al. A randomized double-blind, placebo-controlled crossover study of the effect of exogenous melatonin on delayed sleep phase syndrome. Psychosom Med 2001;63:40-8.
118. Almeida Montes LG, Ontiveros Uribe MP, Cortes Sotres J, et al. Treatment of primary insomnia with melatonin: a double-blind, placebo-controlled, crossover study. J Psychiatry Neurosci 2003;28:191-6.
119. Houghton PJ. The scientific basis for the reputed activity of valerian. J Pharm Pharmacol 1999;51:505-12.
120. Stevenson C, Ernst E. Valerian for insomnia: a systematic review of randomized clinical trials. Sleep Med 2000;1:91-9.
121. Hadley S, Petry JJ. Valerian. Am Fam Physician 2003;4: 229-51.
122. Escher M, Desmeules J, Giostra E, Mentha G. Hepatitis associated with kava, an herbal remedy for anxiety. BMJ 2001;322:139.
123. Michelson D, Page SW, Casey R, et al. An eosinophiliamyalgia syndrome related disorder associated with exposure to L-5-hydroxytryptophan. J Rheumatol 1994;21:2261-5.
124. United States Food and Drug Administration. FDA talk paper. Impurities confirmed in dietary supplement 5-hydroxy-L-tryptophan. August 31, 1998. Available from http://vm.cfsan.fda.gov/~lrd/tp5htp.html. Accessed January 3, 2006.
125. Zhdanova IV, Wurtman RJ, Regan MM, Taylor JA, Shi JP, Lecalir OU. Melatonin treatment for age-related insomnia. J Clin Endocrinol Metab 2001;86:4727-30.
126. Yuan CS, Mehendale S, Xiao Y, et al. The γ-aminobutyric acidergic effects of valerian and valerenic acid on rat brainstem neuronal activity. Anesth Analg 2004;98:353-8.
127. A receptor. J Pharmacol Exp Ther 2004;311:537-46.
128. Foster AC, Pelleymounter MA, Cullen JM, et al. In vivo pharmacologic characterization of indiplon, a novel pyrazolopyrimidine sedative-hypnotic. J Pharmacol Exp Ther 2004;311:547-59.
129. Neurocrine Biosciences. Insomnia: indiplon, IR and MR formulations. Available from www.neurocrine.com. Accessed March 6, 2006.
130. Schraft MB, Black JE, Moscovitch A, et al. Long-term efficacy of tolerability of indiplon-IR in the treatment of chronic insomnia: results of a double-blind, placebo-controlled, 3-month study [abstr]. In: Program and abstracts of the American psychiatric association 2005 annual meeting, Atlanta, GA, May 21-26, 2005. Arlington, VA: American Psychiatric Association.
131. Walsh JK, Roth T, Jochelson P, Moscovitch A, Farber R. Efficacy and tolerability of indiplon-IR in elderly patients with chronic insomnia: results of a double-blind, placebo-controlled, 2-week trial [abstr]. In: Program and abstracts of the American psychiatric association 2005 annual meeting, Atlanta, GA, May 21-26, 2005. Arlington, VA: American Psychiatric Association.
132. Roth T, Zammit G, Jochelson P, Scharf M, Boyd M. Efficacy and safety of indiplon-IR in adults with chronic insomnia characterized by prolonged nighttime awakenings with difficulty returning to sleep [abstr]. In: Program and abstracts of the American psychiatric association 2005 annual meeting, Atlanta, GA, May 21-26, 2005. Arlington, VA: American Psychiatric Association.
133. Lydiard RB, Lankford DA, Jochelson P, Walsh JK, Seiden D. Efficacy and tolerability of indiplon modified-release in elderly patients with chronic insomnia: results of a double-blind, placebo-controlled, 2-week study [abstr]. In: Program and abstracts of the American psychiatric association 2005 annual meeting, Atlanta, GA, May 21-26, 2005. Arlington, VA: American Psychiatric Association.