A total of 20 consecutive patients with both FD and sleep disturbance were enrolled prospectively. All patients met the criteria of Rome IV for Functional Dyspepsia [10]. All patients had sleep disturbance with a total score of more than 5.5 in the Pittsburgh Sleep Quality Index (PSQI) [11]. Patients who had a history of GI surgery, those who had taken sleep aids, those who had changed therapy for FD except sleep aids during the study period, and those who were younger than 20 years old were excluded from the present study.

All patients gave written informed consent for this study, which was performed in accordance with the Helsinki Declaration. The study protocol was approved by the Institutional Review Board at Gunma University Hospital, Kohseichuo General Hospital and Osaka City University Graduate School of Medicine.