A Randomized, Double-Blind, Single-Dose, 2-Way Cross-Over Study to Assess the Pharmacodynamic Effects of SM-1 vs. Active Comparator in a 3-Hour Phase Advance Model of Transient Insomnia
Sequential Medicine Ltd
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.
Description
The purpose of this study is to evaluate the effect of a combination drug product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam on total sleep time, and to determine the contribution of zolpidem to the combination, using a 3-hour Phase Advance model of sleep challenge with 8 hours of polysomnographic (PSG) recording. This is a 2-arm, 2-period crossover trial including the 3-drug investigational product and a 2-drug comparator. The 2 arms are: investigational combination product, and a 2-drug comparator containing diphenhydramine and lorazepam but not zolpidem. Participan…
Eligibility
- Age range
- 25–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 25 and 55 years 2. Body mass index (BMI) between 19 and 32 kg/m2 3. Report previous history of occasional difficulty falling asleep or staying asleep, but not currently having difficulty sleeping; 4. Regular, habitual bedtime between 21:00 and 24:00, routinely spend at least 7.5 and no more than 9.0 hours in bed nightly and a bedtime that does not vary by more than 2 hours over the course of the week. 5. Good general health 6. Females of childbearing potential must be using an acceptable method of contraception, have a negative serum pregnancy test at screening and…
Interventions
- DrugSM-1
diphenhydramine, zolpidem and lorazepam
- DrugActive Comparator
diphenhydramine and lorazepam
Location
- Clinilabs Drug Development CorporationNew York, New York