Efficacy of a Combination of Melissa officinalis L. and Nepeta Menthoides Boiss. & Buhse on Insomnia: A Triple-Blind, Randomized Placebo-Controlled Clinical Trial.

BACKGROUND: Insomnia is a prevalent sleep disorder that has not been well managed thus far. There are numerous medicaments for treatment of insomnia, but they have undesirable side effects that make herbal medicine a more viable option. OBJECTIVES: The effectiveness of a combination of Melissa officinalis L. (dry powder) and Nepeta menthoides Boiss. & Buhse (freeze-dried aqueous extract) on insomnia was evaluated. DESIGN AND SETTING: Insomniacs who met the entry criteria participated in a triple-blind randomized placebo-controlled clinical trial at the Persian Medicine (PM) clinic in Tehran. INTERVENTIONS: The subjects received either 1000 mg of M. officinalis plus 400 mg N. menthoides or a placebo nightly for four weeks in accordance with prescriptions from the pharmaceutical manuscripts on PM and the results of previous studies. OUTCOME MEASURES: The Pittsburgh Sleep Quality Index (PSQI), sleep diary, and Insomnia Severity Index (ISI) were used for assessment of insomnia. RESULTS: Comparison of the treatment and placebo groups showed a significant decrease in the mean difference of ISI (4.97 ± 4.69 vs. 1.60 ± 3.70; p =; 0.002) and total PSQI (4.14 ± 3.69 vs. 1.42 ± 2.81; p = 0.001) scores in the treatment group. A significant increase was also observed in total sleep time of treatment group (p < 0.001) based on the sleep diary. CONCLUSIONS: A combination of M. officinalis and N. menthoides Boiss. & Buhse could be an alternative sleep improvement therapy.