What side effects are associated with this type of intervention?

Melatonin, commonly used to treat insomnia, is generally well tolerated with few serious adverse effects reported. Common side effects include headaches, somnolence, hypotension, hypertension, gastrointestinal upset, and exacerbation of alopecia areata, particularly at higher doses. Long-term safety data are limited, but short-term use of up to 10 mg/day appears safe in healthy adults. Melatonin receptor agonists like ramelteon and tasimelteon may also cause headaches, elevated liver function tests, and nightmares or abnormal dreams. Overall, melatonin and its analogs are considered safe for most patients, though caution is advised in specific populations such as children and women of reproductive age.

What prior FDA approvals exist?

The FDA has approved several treatments for insomnia that are similar to melatonin, focusing on regulating sleep-wake cycles and circadian rhythms. Notably, melatonin receptor agonists such as ramelteon and tasimelteon have been approved. Ramelteon is used for the treatment of insomnia characterized by difficulty with sleep onset, while tasimelteon is approved for non-24-hour sleep-wake disorder, particularly in blind individuals. These drugs mimic the action of melatonin by binding to melatonin receptors, thereby helping to regulate the circadian rhythm and improve sleep patterns.

What other types of research exist?

Promising novel alternatives to melatonin for insomnia patients include: 1) Light therapy, particularly using short-wavelength (blue) light exposure in the morning, which has been shown to advance circadian phases and improve sleep. 2) Light flashes during sleep and wearable light devices, which are emerging as effective tools for circadian rhythm regulation. 3) Melatonin agonists like agomelatine, which have demonstrated phase-shifting capabilities in older adults. 4) Non-pharmacological interventions such as improved sleep hygiene practices and controlled exposure to electronic devices that emit blue light. These alternatives offer various mechanisms to regulate sleep-wake cycles and circadian rhythms effectively.

← Back to Search

Hormone Therapy

Melatonin for Insomnia

N/A

Recruiting

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

Must not have

Evidence of sleep apnea (apnea/hypopnea index > 15 per hour of sleep) or restless legs, or periodic limb movements during sleep (number of PLMs >15 per hour of sleep)

Timeline

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

Summary

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.

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.

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.

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

Select...

I am a woman with insomnia for 3 months due to menopause.

Select...

I am a postmenopausal woman who has not had a period for at least 12 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with severe sleep apnea or restless legs/limb movements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between treatment conditions at bedtime at treatment days 14-15

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sleep duration

Change in sleep efficiency

Change in wake after sleep onset

+1 more

Secondary study objectives

Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)

Thermography

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

FDA approved

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for insomnia include melatonin supplementation, light therapy, and strategic avoidance of evening light. Melatonin works by regulating sleep-wake cycles and circadian rhythms through its action on specific receptors in the brain, which helps to signal the body that it is time to sleep. Light therapy involves exposure to bright light at specific times to help reset the circadian clock, while avoiding evening light can prevent disruptions in circadian timing. Understanding these mechanisms is crucial for insomnia patients as it allows for targeted interventions that can improve sleep quality and overall health by aligning treatment with the body's natural biological rhythms.

Reentrainment of rat circadian activity rhythms: effects of melatonin.Treatment of a patient with a circadian sleep-wake disorder using a combination of melatonin and metoprolol.Basic chronobiology: what do sleep physicians need to know?