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Sedative

Active Treatment: SM-1 3-Drug Combination for 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

Study Summary

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

Eligible Conditions
  • Transient 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

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

Side effects data

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

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
2 Trials studying Transient Insomnia
85 Patients Enrolled for Transient Insomnia
Maha Ahmad, MD, MMScPrincipal InvestigatorClinilabs Drug Development Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
SM-1 vs. an Active Comparator in A Model of Transient Insomnia
2020. "SM-1 vs. an Active Comparator in A Model of Transient Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04396327.
All > Insomnia
~3 spots leftby Apr 2025
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