Short-term Insomnia Clinical Trial
Official title:
A Randomized, Double-Blind, Single-Dose Study to Assess the Pharmacodynamic Effects of SM-1 Versus Comparator and Placebo in a 5 Hour Phase Advance Model of Insomnia in Adults Who Suffer From Short-Term Insomnia
The purpose of this study is to evaluate the effect of a combination drug product containing diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who do not have chronic insomnia. The study involves 3 one-night stays in a sleep center in New York City.
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 diphenhydramine to the combination, using a 5-hour Phase
Advance model of sleep challenge. This is a 3-arm cross-over study; each participant will
receive 3 single-dose treatments on consecutive visits. The 3 arms are: investigational
combination product, placebo, and a 2-drug comparator containing the zolpidem and lorazepam
components but not diphenhydramine. 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 39 subjects are being recruited. Subjects who qualify for participation will be
asked to keep a sleep diary to document their sleep times leading up to and during the study,
and will be asked to spend 7-8 hours in bed at a regular bedtime during the study. Qualifying
participants also will not anticipate significant disruptions in their sleep schedules, for
example by traveling across timezones or changing shifts at work, during the study. The study
requires 3 one-night stays in a sleep center in New York City, for administration of the
study treatments and EEG measurements. Qualifying subjects will anticipate being able to
return to the sleep center, located in Manhattan, for a total of 4 visits, including initial
screening and 3 treatment times.
During each sleep center visit, subjects will be given their study treatment and be put to
bed 5 hours before their usual bedtime, and sleep time will be monitored for 8 hours. Each
subject will receive all 3 treatments, although the sequence of the 3 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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06212934 -
"Chou's Tiaoshen" Acupoints for Short-term Insomnia.
|
N/A |