drugset / Trial / NCT03338764
An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the efficacy and pattern of use of the combination drug product SM-1 in adults who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or placebo to take at home as needed over the course of 3 months treatment period.
Timeline
- Start
- 2023-05
- Primary completion
- 2023-12
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diphenhydramine | Unknown | 50 mg | — |
| Subject | Lorazepam | Small molecule | 0.5 mg | — |
| Subject | Zolpidem | Small molecule | 5 mg | — |