SM-1 vs. an Active Comparator in A Model of Transient Insomnia

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.

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. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who are generally healthy and do not have chronic insomnia or sleep apnea. A total of 14 subjects are planned to enroll in the study. Subjects who qualify for participation will be asked to keep a sleep diary to document their sleep times leading up to their first overnight stay in the sleep center and during the study. Subjects will be asked to spend at least 7.5 hours in bed at a regular bedtime during the study. Qualifying participants also will not anticipate traveling across 3 time zones, be involved in night shift work, or significant disruptions in their sleep schedules during the study. The study requires 2 one-night stays in a sleep center in New York City, for administration of the study treatments and PSG \& EEG measurements. Qualifying subjects will anticipate being able to return to the sleep center, located in Manhattan, for a total of 3 visits, including initial screening and 2 treatment times. Subjects will receive a follow up phone call from study staff 3 days after final dose of study medication. During each sleep center visit, subjects will arrive to the sleep center approximately 5 hours prior to their average usual bedtime and will be given their study treatment. Their sleep will be monitored for 8 hours. Each subject will receive both treatments, although the sequence of the 2 treatments will be randomized. Both subjects and study personnel monitoring the subjects will be blinded to the identity of the treatment administered at each visit.