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Cited by 190Medicinal Plant Extracts EffectsSleep and related disordersComplementary and Alternative Medicine Studies

Valerian-Hops Combination and Diphenhydramine for Treating Insomnia: A Randomized Placebo-Controlled Clinical Trial

Morin, Charles M., Koetter, Uwe, Bastien, Célyne, Ware, J. Catesby, Wooten, Virgil·2005·Sleep
DOI 10.1093/sleep/28.11.1465
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Abstract

Context Insomnia is a prevalent health complaint associated with daytime impairments, reduced quality of life, and increased health-care costs. Although it is often self-treated with herbal and dietary supplements or with over-the-counter sleep aids, there is still little evidence on the efficacy and safety of those products. Objective To evaluate the efficacy and safety of a valerian-hops combination and diphenhydramine for the treatment of mild insomnia. Design and setting Multicenter, randomized, placebo-controlled, parallel-group study conducted in 9 sleep disorders centers throughout the United States. Patients A total of 184 adults (110 women, 74 men; mean age of 44.3 years) with mild insomnia. Interventions (1) Two nightly tablets of standardized extracts of a valerian (187-mg native extracts; 5-8:1, methanol 45% m/m) and hops (41.9-mg native extracts; 7-10:1, methanol 45% m/m) combination for 28 days (n = 59), (2) placebo for 28 days (n = 65), or (3) 2 tablets of diphenhydramine (25 mg) for 14 days followed by placebo for 14 days (n = 60). Outcome measures Sleep parameters measured by daily diaries and polysomnography, clinical outcome ratings from patients and physicians, and quality of life measures. Results Modest improvements of subjective sleep parameters were obtained with both the valerian-hops combination and diphenhydramine, but few group comparisons with placebo reached statistical significance. Valerian produced slightly greater, though nonsignificant, redu…

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  • Evidence for efficacy and safety of antihistamines and antihistamine-analgesic combinations for insomnia is very limited, with very few available studies from the past 10 years using contemporary study designs and outcomes.

    “Evidence for their efficacy and safety is very limited, with very few available studies from the past 10 years using contemporary study designs and outcomes. 43”

    From Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults (2008) · cites this paper as [43]

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Authors
Morin, C. M., Koetter, U., Bastien, C., Ware, J. C., & Wooten, V.
Affiliations
  • Université Laval (CA)
  • Max Zeller Söhne (Switzerland) (CH)
  • Sentara Norfolk General Hospital (US)
  • TriHealth (US)
Corresponding author
Morin, Charles M.
ORCID
Venue
Sleep
Publisher
Oxford University Press (OUP)
Published
2005-11
Volume
28
Issue
11
Pages
1465-1471
ISSN
  • 0161-8105 (ISSN-L)
  • 1550-9109
DOI
10.1093/sleep/28.11.1465
OpenAlex
W186877966
Cited by
190
References
11
Citations by year
2026: 4 · 2025: 8 · 2024: 11 · 2023: 9 · 2022: 9 · 2021: 13 · 2020: 10 · 2019: 7 · 2018: 7 · 2017: 8 · 2016: 8 · 2015: 15 · 2014: 9 · 2013: 8 · 2012: 12
FWCI
16.84
Type
journal article
Language
en
Open access
closed
Locations
  • SLEEP (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Complementary and alternative medicine › Medicinal Plant Extracts Effects
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
Keywords
insomnia, Valeriana officinalis, Humulus lupulus, diphenhydramine, over-the-counter sleep aids, sleep latency, sleep efficiency, total sleep time, sleep continuity, quality of life, polysomnography, safety and tolerability, daytime dysfunction, REM sleep
MeSH terms
Adult, Aged, Diphenhydramine, Female, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Phytotherapy, Middle Aged, Plant Extracts, Quality of Life, Surveys and Questionnaires, Severity of Illness Index, Sleep Stages, Valerian, Humulus

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