Table 4.

Summary of Safety and Efficacy of Valerian or Valerian/Hops

Study	Participant Characteristics	Outcome Measures	Principal Findings/Outcomes	Significant Secondary Observations and Adverse Events	Interpretation and Limitations	Overall Assessment of the Dataa
Healthy volunteers with or without occasional disturbed sleep
Healthy volunteers with or without occasional disturbed sleep
Diaper and Hindmarch (2004)37 Design: randomized, double-blind, placebo-controlled, crossover, objective, self-report Arms: valerian 600 mg vs 300 mg (Li 156, Sedonium, Lichtwer Pharma) vs placebo Single dose	“Mild sleep complaint” (sleep questionnaire) 50–64 y N = 16 (mean age: 55.9 y, 68.8% female)	Primary: PSG Secondary: LSEQ, mood and psychomotor/memory tests, adverse events	No significant differences between valerian (300 or 600 mg) and placebo for any PSG-derived parameter	No difference in sleep, mood (depression, anxiety), or psychomotor/memory performance Adverse events of mild (valerian 300 mg, placebo) or moderate (valerian 600 mg) intensity, but no dose-related effect on frequency	Valerian 300–600 mg is ineffective as an acute dose for sleep problems Limitations: preliminary trial, single dose, alcoholic extraction	–
Morin et al (2005)23 Design: randomized, double-blind, placebo-controlled, multicenter, objective, self-report Arms: 2 tablets of valerian/hops (each tablet containing 187 mg valerian native extracts and 41.9 mg hops native extracts) vs placebo (vs diphenhydramine) Schedule: 4 wk	Occasional insomnia (sSL 30 min and/or awake after sleep onset > 30 min 2–4 nights/wk) 25–65 y N = 184 (mean age: 44.3 y, 59.8% female)	Primary: sleep diary (active agent vs placebo, sSL, sSE, and sTST at wk 2) Secondary: overnight PSG (baseline to wk 2, subset n = 75), sleep diary (wk 4), ISI, CGI, SF-36, withdrawal/rebound effects, adverse events	Valerian vs placebo: no treatment difference in sSL after 2 wk of treatment (27.5 vs 23.8 min); no improvement in sSE or sTST	Valerian vs placebo: PSG: no significant improvements on SL, sleep efficiency, or TST vs placebo; sleep diary (wk 4): no significant effects; SF-36 (physical) improved at 4 wk (55.0 vs 53.3*); no next-day residual effects or rebound insomnia vs placebo; safety profile similar between groups	Valerian/hops produced some mild improvements, but only 1 observation vs placebo reached statistical significance (QoL measured by SF-36 physical) Limitations: below recommended dose of valerian	–
Oxman et al (2007)38 Design: randomized, double-blind, placebo-controlled, Web-based Arms: Valeriana officinalis (Valerina Forte, Cederroth International AB) 3,600 mg vs placebo Schedule: 2 wk	Self-reported insomnia for at least 1 mo with a PSQI score > 5 18–75 y N = 434 (randomized) Valerian: n = 202 (mean age: 45.7 y, 62% female) Placebo: n = 203 (mean age: 41.8 y, 60% female)	Primary: sleep quality (valerian vs placebo) Secondary: other sleep diary measures (sleep onset, no. of awakenings, sleep duration, next-day energy level), adverse events	Valerian vs placebo: no treatment difference in sleep quality improvement; percentage of individuals showing ≥ 0.5: 28.7% valerian vs 21.2% placebo	Valerian vs placebo: no treatment differences on most secondary sleep measures except average improvement on awakenings and global self-assessment of change (better or much better) No treatment differences in adverse events	Limited beneficial effects of valerian on sleep efficacy in individuals with insomnia symptoms	–
Dimpfel and Suter (2008)39 Design: randomized, double-blind, placebo-controlled, objective Arms: valerian/hops (Valeriana officinalis 460 mg and Humulus lupulus 460 mg) liquid extract (Dormeasan, Bioforce AG) vs placebo Schedule: single dose	Healthy, with occasional poor sleep (sleep questionnaire) 30–70 y N = 42 (males mean age: 48.2 y, females mean age: 50.2 y, % of females not provided)	Primary: PSG time spent in sleep (based on spectral frequency index) (baseline vs treatment night) Secondary: sleep quality (inventory) vs EEG sleep quantity	Time spent in sleep and deep sleep was higher for valerian/hops extract vs placebo**	PSG sleep quantity was correlated with subjective sleep quality (r = 0.48***)	Acute valerian/hops combination improves sleep quantity in subjects with mild sleep disturbance	+
Taibi et al (2009)40 Design: randomized, double-blind, placebo-controlled, cross-over, objective, self-report Arms: valerian (Valeriana officinalis, Nature’s Resource, Pharmavite, LLC) 300 mg vs placebo Schedule: 2 wk	Mild insomnia (PSQI ≥ 5, ISI < 22) 55–80 y N = 16 (mean age: 69.4 y, 100% female)	Primary: WASO, sleep efficiency (PSG, actigraphy, and self-report), sleep latency (PSG, self-report), sleep quality (self-report) in laboratory and at home Secondary: PSG (sleep architecture), adverse events	Valerian vs placebo: no treatment differences on self-reports or PSG measures after single dose or 2 wk of dosing or on actigraphy and self-reports during intervening days at home	No treatment differences on sleep architecture or adverse events	Valerian after a single dose or after 2 wk did not improve sleep in this sample of older women with insomnia	–
Taavoni et al (2011)41 Design: randomized, triple-blind, placebo-controlled, self-report Arms: valerian root extract 530 mg vs placebo, twice a day (time of day not provided) Schedule: 4 wk	Postmenopausal, healthy women with mild self-reported insomnia (PSQI) 50–60 y N = 100 (mean age: ∼53 y, 100% female)	Primary: PSQI (valerian vs placebo at wk 4) Secondary: proportion of participants with PSQI improvement	Valerian vs placebo: significant improvement in PSQI score compared with placebo*** (valerian improvement: 9.8 to 6.02)	30% (valerian) vs 4% (placebo) of participants reported an improvement in sleep quality*** Adverse events not captured	Multiple-dose valerian improved sleep quality in postmenopausal women with mild insomnia	+
Diagnosed insomnia
Koetter et al (2007)42 Design: randomized, double-blind, placebo-controlled, multicenter, objective Arms: valerian extract (Ze 911) 500 mg/d vs valerian 500 mg/hops 120 mg (Ze91019) vs placebo Schedule: 4 wk	Nonorganic insomnia (ICD-10) with prolonged sleep latency ≥ 30 min (mean of 2 objective assessments) at baseline ≥ 18 y N = 30 (mean age: ∼37.7 y, 53.3% female)	Primary: sleep latency on home recorder system (valerian vs placebo baseline to wk 4) Secondary: WASO, sleep efficiency, % sleep stages, REM latency, CGI, adverse events, safety laboratory tests (no details)	Valerian extract vs placebo: no treatment difference, SL: 22.1 vs 5.5 min (values represent change from baseline) Valerian/hops vs placebo: significant improvement in SL: 44.5 vs 5.5 min* (values represent change from baseline)	Slow-wave sleep and CGI showed significant “superiority” for valerian/hops; no other secondary outcomes were significant No adverse events reported for any individual across any treatment group; safety laboratory data within physiologic range	Valerian/hops, but not valerian alone, improved sleep latency in individuals with insomnia and was well tolerated	–/+

^aThe last column provides overall assessment of the data: + = positive study (met primary end point and supports use as a sleep aid), – = negative study (did not meet primary end point and does not support use as a sleep aid).

^*P < .05.

^**P < .01.

^***P < .001.

Abbreviations: CGI = Clinical Global Impressions scale, EEG = electroencephalogram, ISI = Insomnia Severity Index, LSEQ = Leeds Sleep Evaluation Questionnaire, PSG = polysomnography, PSQI = Pittsburgh Sleep Quality Index, QoL,=quality of life, SF-36 = 36-Item Short-Form Health Survey, SL = sleep latency, sSE = sleep efficiency by participant report, sSL = sleep latency by participant report, sTST = total sleep time by participant report, TST = total sleep time by PSG, WASO = wake after sleep onset by PSG.