Transient Insomnia Clinical Trial
Official title:
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
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.
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