SM-1 vs. an Active Comparator in A Model of Transient Insomnia
Recruiting in Palo Alto (17 mi)
Overseen byMaha Ahmad, MD, MMSc
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Sequential Medicine Ltd
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Inclusion Criteria
Age 25 and 55 years
Body mass index (BMI) between 19 and 32 kg/m2
Report previous history of occasional difficulty falling asleep or staying asleep, but not currently having difficulty sleeping;
+7 more
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Active Treatment: SM-1 3-Drug CombinationExperimental Treatment1 Intervention
3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam
Group II: Active Comparator: 2-Drug CombinationActive Control1 Intervention
50 mg diphenhydramine and 0.5 mg lorazepam
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinilabs Drug Development CorporationNew York, NY
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Who Is Running the Clinical Trial?
Sequential Medicine LtdLead Sponsor