drugset / Trial / NCT04396327
SM-1 vs. an Active Comparator in A Model of Transient Insomnia
RandomizedCrossoverDouble-blindTreatment
Summary
The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or a combination of diphenhydramine and lorazepam during 2 one-night stays at a sleep center.
Timeline
- Start
- 2020-05-27
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zolpidem | Small molecule | 5 mg | — |
| Background | Diphenhydramine | Unknown | 50 mg | — |
| Background | Lorazepam | Small molecule | 0.5 mg | — |