Oral nonprescription treatment for insomnia: an evaluation of products with limited evidence.

PURPOSE: To evaluate the level of evidence regarding the safety and efficacy of nonprescription therapies used for insomnia.

REVIEWERS: Members of the American Academy of Sleep Medicine's Clinical Practice Review Committee.

METHODS: A search of the World Wide Web was conducted using the terms insomnia, herbal remedies, and alternative treatments to develop a list of therapies. Therapies in this review include passionflower, valerian, Jamaican dogwood, hops, California poppy, chamomile, lemon balm, St. John's wort, kava kava, wild lettuce, scullcap, Patrinia root, first-generation histamine-1-receptor antagonists, alcohol, calcium, vitamin A, nicotinamide, magnesium, vitamin B12, I-tryptophan, 5-hydroxytryptophan, dietary changes, Natrum muriaticum, and Yoku-kan-san-ka-chimpi-hange. A search of the PubMed database was conducted in October 2002 using MeSH terms insomnia and each product listed in this paper, including only articles published in English between 1980 and 2002. Additional relevant articles from reference lists were also reviewed. Given the paucity of pediatric publications, this age group was excluded from this review.

RESULTS AND CONCLUSIONS: Although randomized, placebo-controlled studies were available for a few compounds, rigorous scientific data supporting a beneficial effect were not found for the majority of herbal supplements, dietary changes, and other nutritional supplements popularly used for treating insomnia symptoms. Nevertheless, such treatments are described as alternative remedies for insomnia. Studies are limited by small numbers of participants and, in some instances, inadequate design, lack of statistical analysis, and sparse use of objective measurements. Sparse or no scientific data were found to support the efficacy of most products as hypnotics, including chamomile and St. John's wort. There is preliminary but conflicting evidence suggesting Valerian officinalis L. and first-generation histamine-1-receptor antagonists have efficacy as mild hypnotics over short-term use. There are significant potential risks associated with the use of Jamaican dogwood, kava kava, alcohol, and I-tryptophan. Physicians may find this information useful in counseling their patients.