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Valerian SUSAN HADLEY, M.D., Middlesex Hospital, Middletown, Connecticut JUDITH J COMPLEMENTARY AND ALTERNATIVE MEDICINE Valerian SUSAN HADLEY, M.D., Middlesex Hospital, Middletown, Connecticut JUDITH J. PETRY, M.D., Vermont Healing Tools Project, Brattleboro, Vermont Valerian is a traditional herbal sleep remedy that has been studied with a variety of methodologic designs using multiple dosages and preparations. Research has focused on subjective evaluations of sleep patterns, particularly sleep latency, and study populations have primarily consisted of self-described poor sleepers. Valerian improves subjective experiences of sleep when taken nightly over one- to two-week periods, and it appears to be a safe sedative/hypnotic choice in patients with mild to moderate insomnia. The evi- dence for single-dose effect is contradictory. Valerian is also used in patients with mild anxiety, but the data supporting this indication are limited. Although the adverse effect profile and tolerability of this herb are excellent, long-term safety studies are lacking. (Am Fam Physician 2003;67:1755-8. Copyright©2003 American Academy of Family Physicians) he root of valerian, a perennial triates, valeric acid) and interaction with neu- herb native to North America, rotransmitters such as GABA (valeric acid and Asia, and Europe, is used most unknown fractions).2,3 commonly for its sedative and hypnotic properties in patients Uses and Efficacy Twith insomnia, and less commonly as an SEDATIVE/HYPNOTIC anxiolytic. Multiple preparations are available, Several clinical studies have shown that and the herb is commonly combined with valerian is effective in the treatment of insom- other herbal medications. This review nia, most often by reducing sleep latency. A addresses only studies that used valerian root double-blind, placebo-controlled trial4 com- as an isolated herb. As with most herbal prod- pared a 400-mg aqueous extract of valerian and ucts available in the United States, valerian a commercial valerian/hops preparation with root extracts are not regulated for quality or placebo of encapsulated brown sugar. A total of consistency. Independent testing laboratories 128 volunteers completed a subjective study4 (such as www.consumerlab.com) generally use evaluating the effects of single doses of each test valeric acid content as a marker for pharmaco- compound taken in random order on sleep logic activity and represent one source for reli- latency, sleep quality, sleepiness on awakening, able information to support product choice. night awakenings, and dream recall. Valerian extract demonstrated statistically significant Pharmacology improvement over placebo in sleep latency and The chemical composition of valerian sleep quality. There was no difference between includes sesquiterpenes of the volatile oil valerian extract and placebo in the other two (including valeric acid), iridoids (valepotri- parameters. The commercial valerian/hops ates), alkaloids, furanofuran lignans, and free preparation resulted in no changes in sleep amino acids such as ␥-aminobutyric acid latency, sleep quality, or night awakenings, and (GABA), tyrosine, arginine, and glutamine. an increase in sleepiness on awakening. No Although the sesquiterpene components of information on the preparation of the com- the volatile oil are believed to be responsible mercial product was available, so the reasons for most of valerian’s biologic effects, it is for the lack of effect are unknown. likely that all of the active constituents of Examination of the study subgroups valerian act in a synergistic manner to pro- showed that the positive effects of valerian 1 See page 1649 for duce a clinical response. Research into physi- extract on sleep were most significant in older definitions of strength- ologic activity of individual components has male patients who considered themselves to of-evidence levels. demonstrated direct sedative effects (valepo- be poor sleepers, female poor sleepers, APRIL 15, 2003 / VOLUME 67, NUMBER 8 www.aafp.org/afp AMERICAN FAMILY PHYSICIAN 1755 younger poor sleepers, smokers, and those mg) of an aqueous extract of valerian root who habitually have lengthy sleep latencies. demonstrated that both groups experienced a Subjects who rated themselves as habitually greater than 50 percent improvement in sleep good sleepers were largely unaffected by the latency and wake time after sleep onset. The valerian extract.4 efficacy results were based on questionnaires, In a double-blind study,5 eight subjects who self-rating scales, and nighttime motor activ- described themselves as having lengthy sleep ity. Electroencephalographic recordings in the latency wore a wrist activity meter and pro- laboratory section of the study showed no dif- vided subjective sleep ratings in a study of the ferences in efficacy between valerian and effects of valerian. Participants received either placebo, and data indicated a dose-dependent a 450- or 900-mg dose of an aqueous extract mild hypnotic effect of the valerian extract.7 of valerian root or placebo. Single-dose (450 A recent systematic review8 of randomized and 900 mg) valerian extract resulted in sig- trials of the effect of valerian on patients with nificant decreases in measured and subjective insomnia included reports in all languages.8 sleep latency and more stable sleep during the [Evidence level B, systematic review of studies first quarter of the night, with no effect on other than randomized controlled trials total sleep time. The 900-mg dose produced (RCTs)] The authors found nine randomized, increased sleepiness on awakening compared double-blind, placebo-controlled trials that with placebo. met the inclusion criteria. Two studies9,10 A randomized, placebo-controlled, double- showed improvement in sleep-related para- blind, cross-over study6 involving 16 patients meters in patients with insomnia who with insomnia confirmed by polysomnogra- received repeated administration over two to phy demonstrated no effects on sleep efficiency four weeks. Another study11 demonstrated after a single 600-mg dose of the valerian effects after days 1 and 8 in slow-wave sleep, extract Sedonium, while multiple doses over 14 but no effect on subjective measures of sleep. days resulted in significant improvement in Results were contradictory in six acute-dose parameters of slow-wave sleep measured by studies.4,5,7,12,13 The authors pointed out the polysomnography. There was a nonsignificant wide variety of methodologies used in the trend toward reduced subjective sleep latency studies, and the lack of attention to factors after the long-term valerian treatment.6 such as randomization, blinding, compliance, Several studies have shown valerian’s effi- withdrawal, confounding variables, diagnostic cacy in patients who do not have sleep distur- criteria, and statistical analysis. They con- bances. A small study7 of 10 patients at home cluded that evidence for valerian in the treat- and eight patients at a sleep laboratory who ment of insomnia is inconclusive, and that received two different dosages (450 and 900 more rigorous trials are necessary. A recent multicenter14 (RCT) compared a 600-mg dose of the valerian extract Sedonium with 10 mg of oxazepam over a six-week The Authors period in 202 patients who were diagnosed SUSAN HADLEY, M.D., is on staff in the family practice division at Middlesex Hospital with non-organic insomnia. The two agents in Middletown, Conn. She is also a member of the Board of Integrative Medicine at Middlesex Hospital. She received her medical degree from the University of Arizona were equally effective in increasing sleep qual- College of Medicine, Tucson, and completed a social medicine residency at Montefiore ity as measured by the Sleep Questionnaire B Medical Center, Bronx, N.Y. (SF-B), and these results were confirmed by JUDITH J. PETRY, M.D., is a consultant in integrative medicine in Westminster, Vt., and subscales of the SF-B, the Clinical Global medical director of Vermont Healing Tools Project in Brattleboro. She received her Impression Scale, and the Global Assessment medical degree from Albany Medical College, Albany, N.Y., and is board certified in general surgery and plastic surgery. of Efficacy. Mild to moderate adverse events occurred in 28.4 percent of patients receiving Address correspondence to Susan Hadley, M.D., Middlesex Hospital, 90 S. Main St., Middletown, CT 06457 (e-mail: [email protected]). Reprints are not avail- the valerian extract and 36.0 percent of able from the authors. patients taking oxazepam. 1756 AMERICAN FAMILY PHYSICIAN www.aafp.org/afp VOLUME 67, NUMBER 8 / APRIL 15, 2003 Valerian therefore, not subject to regulatory control Anxiolytic beyond labeling requirements. According to Traditional herbalists have used valerian as an Commission E monographs,18 there are no anxiolytic, frequently in combination with contraindications to valerian. Reported other herbal preparations such as passion flower adverse effects of valerian are rare. In a and St. John’s wort. There is a minimal amount 14-day, multiple-dose study6 of 16 patients, of scientific data confirming this indication for there were only two adverse events (migraine valerian. One randomized, double-blind, and gastrointestinal effects) in patients receiv- placebo-controlled trial15 compared valerian ing valerian compared with 18 events in (100 mg) with propranolol (20 mg), a valerian- patients receiving placebo. A randomized, propranolol combination, and placebo in an controlled, double-blind study19 of 102 sub- experimental stress situation in 48 healthy sub- jects evaluated reaction time,
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