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Hormone Therapy

Melatonin for Insomnia

Led By Diane B Boivin, MD, PhD
Research Sponsored by Douglas Mental Health University Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Insomniac women meeting the diagnostic criteria for persistent insomnia as described in the DSM-5, reporting subjective sleep onset and/or maintenance difficulties associated with impaired daytime functioning at least 3 times a week, for at least 3 months, coincident with the onset of the menopausal transition
Postmenopausal women with at least 12 months of amenorrhea
Screening 3 weeks
Treatment Varies
Follow Up change between treatment conditions at bedtime at treatment days 14-15
Awards & highlights
All Individual Drugs Already Approved

Study Summary

This trial is testing whether melatonin can help improve sleep and circadian rhythms in postmenopausal women with insomnia.

Who is the study for?
This trial is for postmenopausal women with insomnia, who have trouble sleeping at least three nights a week and it's been going on for over three months. They should not be heavy users of coffee, tobacco, or alcohol and must not have any psychological conditions or other medical issues that could interfere with the study.Check my eligibility
What is being tested?
The study tests if taking melatonin (a sleep hormone) helps improve sleep in these women. It's a crossover study where participants will use either melatonin or a placebo without knowing which one they're taking first, then switch after 15 days.See study design
What are the potential side effects?
Melatonin may cause morning grogginess, daytime drowsiness, mild headaches, dizziness, stomach discomfort and short-term feelings of depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am a woman with insomnia for 3 months due to menopause.
I am a postmenopausal woman who has not had a period for at least 12 months.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between treatment conditions at bedtime at treatment days 14-15
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between treatment conditions at bedtime at treatment days 14-15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sleep duration
Change in sleep efficiency
Change in wake after sleep onset
+1 more
Secondary outcome measures
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
Early Morning Wakening
Daytime drowsiness
Blurred vision
Study treatment Arm

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
2 mg oral tablet, melatonin slow release formulation, 1x 60 min before bedtime for 15 days
Group II: PlaceboPlacebo Group1 Intervention
2 mg oral tablet, 1x 60 min before bedtime for 15 days
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a Location

Who is running the clinical trial?

Douglas Mental Health University InstituteLead Sponsor
29 Previous Clinical Trials
2,712 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,328 Previous Clinical Trials
25,746,363 Total Patients Enrolled
6 Trials studying Insomnia
927 Patients Enrolled for Insomnia
Diane B Boivin, MD, PhDPrincipal InvestigatorDouglas Hospital Research Centre

Media Library

Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05440734 — N/A
Insomnia Research Study Groups: Melatonin, Placebo
Insomnia Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT05440734 — N/A
Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05440734 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what sort of participants is this clinical trial accessible?

"This research is recruiting 14 individuals between the ages of 45 and 65 who experience insomnia. The participants must meet a set of specific criteria, as outlined in DSM-5, such as subjective sleep disturbances impairing daytime functioning at least 3 times per week for over 3 months., postmenopausal women with amenorrhea for 12+ months, drug abstention prior to study commencement, and limited consumption of stimulants like coffee (≤3 cups/day), tobacco (≤ 10 cigarettes/day), alcohol (≤ 15 drinks/week)."

Answered by AI

To what extent is the population being recruited for this clinical research?

"Affirmative. Evidence from clinicaltrials.gov supports the fact that this medical inquiry initially went public on June 17th 2022 and is still actively seeking participants as of October 25th 2022. Currently, 14 individuals are being recruited across 1 site for further research into the topic."

Answered by AI

Does this research encompass participants aged 75 or older?

"The eligibility requirements of this clinical trial necessitate that patients are between 45 and 65 years old. Separately, there exist 24 studies for minors and 180 trials for elderly individuals."

Answered by AI

Is participation in this medical research still open to individuals?

"That is correct. As per the information posted on clinicaltrials.gov, this medical trial remains active and in search of 14 patients from a single location. The study was initially published on June 17th 2022 with it's most recent update being October 25th 2022."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?

What questions have other patients asked about this trial?

What does it entail in its entirety?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Interested in learning more about this. I wouldn’t personally drive to Montreal for this but would do it and go.
PatientReceived 2+ prior treatments
~4 spots leftby Dec 2024