Among adult patients with insomnia, Wuling capsule is a reliable and efficacious treatment to enhance the quality of sleep, according to study findings published in Sleep Medicine.

Insomnia is a risk doorway for multiple medical problems including cardiovascular disease, hypertension, diabetes, and mood disorders and at times, may affect up to 50% or more of the adult population. Benzodiazepines are among the most commonly prescribed medicines for insomnia but come with potential side effects. In China, Wuling capsule, a single herbal formula, has been used for many years as an effective treatment for insomnia, however, according to some studies, the therapeutic effectiveness has been unreliable.

The objective of the current study was to assess Wuling capsule for efficacy and safety in the treatment of insomnia. The primary endpoint, assessed by the Pittsburgh Sleep Quality Index (PSQI), was sleep quality. The secondary endpoints included adverse events and the severity of insomnia disorder, assessed by the Sleep Dysfunction Rating Scale (SDRS).


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The researchers conducted a retrospective systematic review of 1850 participants (930 in treatment groups, 920 in control groups) from 19 randomized controlled trials evaluating Wuling capsule in adults with insomnia, from databases in MEDLINE, EMBASE, Ovid, Cochrane Library, Chinese National Knowledge Infrastructure, VIP information database, Chinese Biomedical Database, and Wanfang, from 2008 to 2021. Wuling capsule was compared with benzodiazepines in 8 of the trials, and, Wuling capsule plus benzodiazepines was compared with benzodiazepines in 4 trials. All trials lasted between 4 and 12 weeks.

PSQI scores were reduced with Wuling capsule (MD: -1.92, 95% CI, [-2.34 – -1.50]; P <.00001; I2 = 95%) compared to control individuals, and Wuling capsule significantly outperformed the control groups as monotherapy (MD: -1.71, 95% CI, [-2.33 – -1.09]; P <.00001; I2 =97%) and as adjunctive therapy (MD: -2.10, 95% CI, [-2.66 – -1.55]; P <.00001; I2 = 90%).

Wuling capsule proved more effective for insomnia when used for 8 weeks than for 4 weeks (MD: -2.57, 95% CI, [-3.52 – -1.62]; P <.00001; I2 = 93%) and (MD: -1.68, 95% CI, [-2.13 – -1.22]; P <.00001; I2 = 95%), respectively. In comparison to benzodiazepines, Wuling capsule lowered SDRS scores (MD: -4.21, 95% CI, [-4.95 – -3.46]; P <.00001; I2 = 0%). The drug significantly reduced adverse events compared to controls (RR: 0.47, 95% CI, [0.34 – 0.65]; P <.00001; I2 = 43%).

The study had several limitations, the researchers acknowledged. Among the limitations, included the missing details of randomization in many of the studies to heterogeneity and publication bias.

“Wuling capsule can safely and effectively improve sleep quality in patients with insomnia disorder,” according to researchers. However, “the findings of this study are not strong enough to support the use of Wuling capsule as a treatment for insomnia disorder,” they concluded.

Reference

Zhou H, Zhao Y, Peng W, et al. Efficacy and safety of Wuling capsule for insomnia disorder: A systematic review and meta-analysis of randomized controlled trials. Sleep Med. Published online March 24, 2022. doi:10.1016/j.sleep.2022.03.014