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 zolpidem, or a combination of diphenhydramine and lorazepam, or placebo during 4 one-night stays at a sleep center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.
2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.
2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Clinilabs, Inc.
New York, New York, United States
Total Sleep Time (TST)
TST efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-defined total sleep time (TST)
Time frame: 8 hours
Latency to Persistent Sleep (LPS)
Efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep induction, the amount of time it takes the subject to fall asleep.
Time frame: 8 hours
Number of Awakenings (NAW)
NAW efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance.
Time frame: 8 hours
Wakefulness After Sleep Onset (WASO)
WASO efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance as the amount of time spent awake after falling asleep.
Time frame: 8 hours
Karolinska Sleepiness Scale (KSS) of Morning Alertness.
Morning alertness measured by Karolinska Sleepiness Scale (KSS). KSS ranges from 1-9, with higher numbers indicating sleepier and lower numbers more alert.
Time frame: Up to Visit 5
Number Correct on Digit Symbol Substitution Test (DSST)
Morning alertness measured by DSST. The digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment. Scores on the DSST range from 0-93
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.
Time frame: Up to Visit 5
Subjective Total Sleep Time (sTST)
Subject reported TST from Post-Sleep Questionnaire (PSQ).
Time frame: Up to 22 days.
Subjective Sleep Onset Latency (sSOL)
Subject reported SOL, the amount of time the subject felt it took to fall asleep, from Post-Sleep Questionnaire (PSQ).
Time frame: Up to 22 days.
Subjective Number of Awakenings (sNAW)
Subject reported NAW from Post-Sleep Questionnaire (PSQ).
Time frame: Up to 22 days.
Number of Participants According to Sleep Quality
Subject reported sleep quality, how well the subject felt he or she slept, from Post-Sleep Questionnaire (PSQ).
Time frame: Up to 22 days.