Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label StudyTsuyoshi Miyaoka*, Kiminori Kawano, Motohide Furuya, Rei Wake, Sadayuki Hashioka, KristianLiaury, Erlyn Limoa, Keiko Tsuchie, Michiyo Fukushima, Tomoko Araki and Jun Horiguchi
Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan
- *Corresponding Author:
- Tsuyoshi Miyaoka
Department of Psychiatry
Shimane University School of Medicine
89-1 Enyacho, Izumo 693-8501, Japan,
E-mail: [email protected]
Received date August 01, 2014; Accepted date December 30, 2014; Published date January 01, 2015
Citation: Miyaoka T, Kawano K, Furuya M, Wake R, Hashioka S, et al (2015) Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label Study. Altern Integr Med 4:181. doi:10.4172/2327-5162.1000181
Copyright: ©2015 Miyaoka T, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: Prior research confirms that insomnia is highly prevalent in patients with psychiatric disorders. Benzodiazepine hypnotics, causing serious disadvantages, have been widely used in psychiatry for a long time. Sansoninto (SNT), Japanese herbal medicine, is used for patients with weakness and fatigue, annoyance, insomnia, amnesia, and neurotic symptoms.
Objective: The efficacy and safety of SNT was examined in adult psychiatric disorder patients with insomnia symptoms.
Methods: Eighty-one adults with sleep disturbance meeting DSM-IV-TR diagnostic criteria for psychiatric disorders (schizophrenia: 17; monopolar depression: 20; bipolar depression: 10; adjustment disorder: 12; anxiety disorder: 5; others: 17) were treated openly for four weeks with SNT (2.5-7.5 g) at bedtime. Patients maintained sleep throughout the study. Efficacy was analyzed using a repeated measures methodology. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes were the Insomnia Severity Index (ISI), Athens Insomnia Scale (AIS), Clinical Global Impression-Improvement (CGI-I), and change of dosage of benzodiazepine hypnotics (diazepam equivalent).
Results: After 4 weeks of SNT therapy, significant symptom reduction was observed on all parameters (PSQI: 10.22 ± 3.23 vs. 3.11 ± 3.52; ISI: 20.63 ± 4.86 vs. 3.38 ± 5.10; AIS: 17.41 ± 4.69 vs. 2.85 ± 4.23; dosage of benzodiazepine hypnotics [diazepam equivalent, mg]:10.5 ± 4.71 vs. 2.98 ± 3.37). No withdrawal involved treatmentrelated adverse events.
Conclusion: Data from this 4-week open-label study suggests SNT was an effective and generally well tolerated treatment for insomnia symptoms in this sample of adult patients with psychiatric disorders.
Trial Registration: controlled-trials.com Identifier: UMIN000014156.