Sleep Medicine
Volume 10, Issue 3 , Pages 319-328 , March 2009

A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia

  • Diana M. Taibi

      Affiliations

    • Department of Biobehavioral Nursing & Health Systems, School of Nursing, University of Washington, Box 357266, Seattle, WA 98195-7262, USA
    • ,
  • Michael V. Vitiello

      Affiliations

    • Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA
    • ,
  • Suzanne Barsness

      Affiliations

    • Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA
    • ,
  • Gary W. Elmer

      Affiliations

    • Department of Medicinal Chemistry, School of Pharmacy, University of Washington, Seattle, WA, USA
    • Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA, USA
    • ,
  • Gail D. Anderson

      Affiliations

    • Department of Biobehavioral Nursing & Health Systems, School of Nursing, University of Washington, Box 357266, Seattle, WA 98195-7262, USA
    • ,
  • Carol A. Landis

      Affiliations

    • Department of Biobehavioral Nursing & Health Systems, School of Nursing, University of Washington, Box 357266, Seattle, WA 98195-7262, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 206 616 1908; fax: +1 206 543 4771.

Received 2 November 2007 ,Revised 30 January 2008 ,Accepted 5 February 2008.

References 

  1. Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995;18(6):425–432
  2. National Sleep Foundation. 2003 Sleep in America Poll. [Internet] 2003 [cited 2007 October 9]. Available from: http://www.kintera.org/atf/cf/F6BF2668-A1B4-4FE8-8D1A-A5D39340D9CB/2003SleepPollExecSumm.pdf.
  3. Vitiello MV, Larsen LH, Moe KE. Age-related sleep change: gender and estrogen effects on the subjective-objective sleep quality relationships of healthy, noncomplaining older men and women. J Psychosom Res. 2004;56(5):503–510
  4. Floyd JA, Medler SM, Ager JW, Janisse JJ. Age-related changes in initiation and maintenance of sleep: a meta-analysis. Res Nurs Health. 2000;23(2):106–117
  5. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97–111
  6. Cooke JR, Ancoli-Israel S. Sleep and its disorders in older adults. Psychiatr Clin North Am. 2006;29(4):1077–1093
  7. Ancoli-Israel S. Sleep and aging: prevalence of disturbed sleep and treatment considerations in older adults. J Clin Psychiatry. 2005;66(Suppl. 9):24–30
  8. Roberts RE, Shema SJ, Kaplan GA, Strawbridge WJ. Sleep complaints and depression in an aging cohort: a prospective perspective. Am J Psychiatry. 2000;157(1):81–88
  9. Dew MA, Hoch CC, Buysse DJ, Monk TH, Begley AE, Houck PR, et al. Healthy older adults’ sleep predicts all-cause mortality at 4 to 19 years of follow-up. Psychosom Med. 2003;65(1):63–73
  10. Basu R, Dodge H, Stoehr GP, Ganguli M. Sedative-hypnotic use of diphenhydramine in a rural, older adult, community-based cohort: effects on cognition. Am J Geriatr Psychiatry. 2003;11(2):205–213
  11. Aparasu RR, Mort JR, Brandt H. Psychotropic prescription use by community-dwelling elderly in the United States. J Am Geriatr Soc. 2003;51(5):671–677
  12. Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005;331(7526):1169
  13. Wagner J, Wagner ML, Hening WA. Beyond benzodiazepines: alternative pharmacologic agents for the treatment of insomnia. Ann Pharmacother. 1998;32(6):680–691
  14. 2003 National Sleep Disorders Research Plan. Sleep 2003;26(3):253–257.
  15. Eisenberg DM, Kessler RC, Van Rompay MI, Kaptchuk TJ, Wilkey SA, Appel S, et al. Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey. Ann Intern Med. 2001;135(5):344–351
  16. Kessler RC, Davis RB, Foster DF, Van Rompay MI, Walters EE, Wilkey SA, et al. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann Intern Med. 2001;135(4):262–268
  17. Ni H, Simile C, Hardy AM. Utilization of complementary and alternative medicine by United States adults: results from the 1999 national health interview survey. Med Care. 2002;40(4):353–358
  18. Bliwise DL, Ansari FP. Insomnia associated with valerian and melatonin usage in the 2002 National Health Interview Survey. Sleep. 2007;30(7):881–884
  19. Pearson NJ, Johnson LL, Nahin RL. Insomnia, trouble sleeping, and complementary and alternative medicine: analysis of the 2002 National Health Interview Survey data. Arch Intern Med. 2006;166(16):1775–1782
  20. Cuellar NG, Rogers AE, Hisghman V. Evidenced based research of complementary and alternative medicine (CAM) for sleep in the community dwelling older adult. Geriatr Nurs. 2007;28(1):46–52
  21. Houghton PJ. The scientific basis for the reputed activity of Valerian. J Pharm Pharmacol. 1999;51(5):505–512
  22. Cavadas C, Araujo I, Cotrim MD, Amaral T, Cunha AP, Macedo T, et al. In vitro study on the interaction of Valeriana officinalis L. extracts and their amino acids on GABAA receptor in rat brain. Arzneimittelforschung. 1995;45(7):753–755
  23. Santos MS, Ferreira F, Cunha AP, Carvalho AP, Macedo T. An aqueous extract of valerian influences the transport of GABA in synaptosomes. Planta Med. 1994;60(3):278–279
  24. Schumacher B, Scholle S, Holzl J, Khudeir N, Hess S, Muller CE. Lignans isolated from valerian: identification and characterization of a new olivil derivative with partial agonistic activity at A(1) adenosine receptors. J Nat Prod. 2002;65(10):1479–1485
  25. Marder M, Viola H, Wasowski C, Fernandez S, Medina JH, Paladini AC. 6-Methylapigenin and hesperidin: new valeriana flavonoids with activity on the CNS. Pharmacol Biochem Behav. 2003;75(3):537–545
  26. Khom S, Baburin I, Timin E, Hohaus A, Trauner G, Kopp B, et al. Valerenic acid potentiates and inhibits GABA(A) receptors: molecular mechanism and subunit specificity. Neuropharmacology. 2007;53(1):178–187
  27. Jansen W. Double blind trial of a mixture of valerian extract with valepotriates. Therapiewoche. 1977;27(14):2779–2786
  28. Kamm Kohl AV, Jansen W, Brockmann P. Moderne Baldriantherapie gegen nervöse Störungen im Senium. Med Welt. 1984;35:1450–1454
  29. Schulz H, Stolz C, Muller J. The effect of valerian extract on sleep polygraphy in poor sleepers: a pilot study. Pharmacopsychiatry. 1994;27(4):147–151
  30. Diaper A, Hindmarch I. A double-blind, placebo-controlled investigation of the effects of two doses of a valerian preparation on the sleep, cognitive and psychomotor function of sleep-disturbed older adults. Phytother Res. 2004;18(10):831–836
  31. Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res. 2002;53(3):737–740
  32. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213
  33. Morin CM, Mimeault V, Gagne A. Nonpharmacological treatment of late-life insomnia. J Psychosom Res. 1999;46(2):103–116
  34. American Psychological Association. Sleep disorders. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Publishing; 1994, p. 597–661.
  35. Edinger JD, Bonnet MH, Bootzin RR, Doghramji K, Dorsey CM, Espie CA, et al. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group. Sleep. 2004;27(8):1567–1596
  36. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189–198
  37. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999;282(18):1737–1744
  38. Russo J, Vitaliano PP. Life events as correlates of burden in spouse caregivers of persons with Alzheimer’s disease. Exp Aging Res. 1995;21(3):273–294
  39. Vitiello MV, Moe KE, Prinz PN. Sleep complaints cosegregate with illness in older adults: clinical research informed by and informing epidemiological studies of sleep. J Psychosom Res. 2002;53(1):555–559
  40. Rechtschaffen A, Kales A. A manual of standardized terminology: techniques and scoring system for sleep stages in human subjects. Los Angeles: UCLA Service/Brain Research Institute; 1968;
  41. Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003;26(3):342–392
  42. Lichstein KL, Stone KC, Donaldson J, Nau SD, Soeffing JP, Murray D, et al. Actigraphy validation with insomnia. Sleep. 2006;29(2):232–239
  43. Schulz V, Hansel R, Tyler VE. Rational phytotherapy: a physician’s guide to herbal medicine. New York: Springer; 2001;
  44. Moore M. Medicinal plants of the Pacific west. Santa Fe: Red Crane Books; 1993;
  45. Taibi DM, Bourguignon C, Taylor AG. The effects of valerian extract on sleep disturbances in persons with arthritis. Sleep. 2006;29(Suppl.):A316
  46. Vorbach EU, Gortelmeyer R, Bruning J. Therapie von Insomnien: Wirksamkeit und Veträglichkeit eines Baldrianpräparats. Psychopharmakotherapie. 1996;3(3):109–115
  47. Coxeter PD, Schluter PJ, Eastwood HL, Nikles CJ, Glasziou PP. Valerian does not appear to reduce symptoms for patients with chronic insomnia in general practice using a series of randomized n-of-1 trials. Complement Ther Med. 2003;11(4):215–222
  48. Morin CM, Koetter U, Bastien C, Ware JC, Wooten V. Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial. Sleep. 2005;28(11):1465–1471
  49. Jacobs BP, Bent S, Tice JA, Blackwell T, Cummings SR. An internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia. Medicine. 2005;84(4):197–207
  50. Brattstrom A. Scientific evidence for a fixed extract combination (Ze 91019) from valerian and hops traditionally used as a sleep-inducing aid. Wien Med Wochenschr. 2007;157(13–14):367–370
  51. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13–15, 2005. Sleep 2005;28(9):1049–57.
  52. Taibi DM, Landis CA, Petry H, Vitiello MV. A systematic review of valerian as a sleep aid: safe but not effective. Sleep Med Rev. 2007;11(3):209–230
  53. Bent S, Padula A, Moore D, Patterson M, Mehling W. Valerian for sleep: a systematic review and meta-analysis. Am J Med. 2006;119(12):1005–1012
  54. Kuhlmann J, Berger W, Podzuweit H, Schmidt U. The influence of valerian treatment on ‘reaction time, alertness and concentration’ in volunteers. Pharmacopsychiatry. 1999;32(6):235–241
  55. Polo-Kantola P, Saaresranta T, Polo O. Aetiology and treatment of sleep disturbances during perimenopause and postmenopause. CNS Drugs. 2001;15(6):445–452
  56. Anderson GD, Elmer GW, Kantor ED, Templeton IE, Vitiello MV. Pharmacokinetics of valerenic acid after administration of valerian in healthy subjects. Phytother Res. 2005;19(9):801–803
  57. 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(11):991–999

☆ This was not an industry supported study. None of the authors has a financial conflict of interest.

PII: S1389-9457(08)00021-X

doi: 10.1016/j.sleep.2008.02.001

Sleep Medicine
Volume 10, Issue 3 , Pages 319-328 , March 2009

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