Melatonin for Insomnia

Recruiting in Palo Alto (17 mi)

Overseen byDiane B Boivin, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Douglas Mental Health University Institute

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests a slow-release melatonin pill to help postmenopausal women with sleep problems. The pill works by mimicking the body's natural sleep hormone to regulate sleep patterns. Melatonin has been studied extensively for its sleep-promoting effects in various populations, including the elderly and those with sleep disorders.

Eligibility Criteria

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.

Inclusion Criteria

You are not currently taking any medications and have only used moderate amounts of coffee, tobacco, alcohol, or other substances in the past.

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.

Exclusion Criteria

You have worked night shifts or traveled across more than 2 time zones in the 2 months before the study.

You show signs of mental health issues during specific interviews and questionnaires.

I have not had any gynecological conditions or surgeries that could affect this study.

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Participant Groups

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.

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

Melatonin is already approved in European Union, European Union, United States for the following indications:

🇪🇺 Approved in European Union as Circadin for: