The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• Psychophysiologic insomnia

• Severity: mild to moderate

• Duration: subacute to chronic

• Subjects age > 18 and < 65, men or women

• Subject had to give written informed consent

Exclusion Criteria:

• Regular use of psycho-active drugs

• Work in shifts

• Use of psychoactive drugs during the past 30 days

• Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)

• known hypersensitivity to any of the ingredients of the study drug

• Pregnancy, lactation, women of childbearing potential not using an established contraceptive

• Drug and alcohol abuse

• Participation in another trial within the past 30 days