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Sedative

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

Phase 2
Waitlist Available
Led By Maha Ahmad, MD, MMSc
Research Sponsored by Sequential Medicine Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug combination to help people who sometimes have difficulty falling asleep or staying asleep.

Eligible Conditions
  • Acute Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Latency to Persistent Sleep (LPS)
Secondary study objectives
Adverse Events
Subjective Sleep Latency
Wakefulness
Other study objectives
Total Sleep Time (TST)

Side effects data

From 2018 Phase 3 trial • 85 Patients • NCT03331042
1%
nightmare
1%
somnolence
1%
asthenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
SM-1
Diphenhydramine Plus Zolpidem
Diphenhydramine Plus Lorazepam
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SM-1
2016
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

Sequential Medicine LtdLead Sponsor
3 Previous Clinical Trials
124 Total Patients Enrolled
Maha Ahmad, MD, MMScPrincipal InvestigatorClinilabs Drug Development Corporation
~3 spots leftby Dec 2025
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