What side effects are associated with this type of intervention?

Common treatments for chronic insomnia include benzodiazepines, Z-drugs (such as zolpidem and zopiclone), and histamine-1 receptor blockers like mirtazapine. Benzodiazepines and Z-drugs are associated with side effects such as cognitive impairment, rebound insomnia, falls, and addiction. Mirtazapine, while effective in improving sleep, can cause somnolence, weight gain, and elevated alanine aminotransferase levels. These side effects should be considered when choosing a treatment for chronic insomnia.

What prior FDA approvals exist?

FDA-approved treatments for chronic insomnia include benzodiazepines and Z-drugs such as zolpidem and zopiclone. These medications are known for their sedative effects and are commonly used to induce sleep. Similar to mirtazapine, which acts as a histamine-1 receptor blocker with hypnotic and sedative properties, these drugs help manage insomnia by promoting sleep. However, they are associated with side effects like cognitive impairment, rebound insomnia, falls, and potential addiction.

What other types of research exist?

Promising alternatives to Mirtazapine for chronic insomnia include newer second-generation antihistamines like Cetirizine and Loratadine, which have minimal sedative effects but can still aid in sleep. Additionally, Triprolidine, a first-generation antihistamine, has shown efficacy in treating temporary sleep disturbances and may be considered for chronic use under medical supervision. These alternatives offer a balance of efficacy and safety, making them suitable options for consideration in 2024.

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Antidepressant

Mirtazapine for Chronic Insomnia (MIRAGE Trial)

Phase 1

Waitlist Available

Led By Patrick VQ Nguyen

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sleep complaint cannot be explained by a sleep disorder other than chronic insomnia

Age 65 years and older

Must not have

Parkinson's disease

Active psychiatric illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for mirtazapine and placebo group : assess the change in the insomnia severity index between the initial examination (day 1) and the end of the treatment course (day 36)

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial aims to test if mirtazapine, a sleep aid, is safe and effective for older adults with chronic insomnia. The study will involve people aged 65 and older over a few weeks. Researchers will measure how well it improves sleep and monitor any side effects. Mirtazapine has been shown to improve total sleep time, sleep efficiency, and sleep quality in previous studies.

Who is the study for?

This trial is for older adults aged 65 and over who have chronic insomnia, which means they have trouble falling or staying asleep. Participants should experience these sleep issues at least three times a week with daytime consequences for more than three months. They can't join if they've had multiple falls recently, use melatonin or other insomnia drugs, are undergoing cognitive therapy for insomnia, have major neurocognitive disorders, Parkinson's disease, or an active psychiatric illness.

What is being tested?

The study tests the effectiveness and safety of Mirtazapine (7.5 mg) against a placebo in treating chronic insomnia among older adults. It's a double-blind trial where neither participants nor researchers know who gets the real medicine versus the placebo. The treatment lasts for 28 days with assessments using sleep quality indexes.

What are the potential side effects?

While not specified here, common side effects of Mirtazapine may include drowsiness, increased appetite leading to weight gain, dry mouth, constipation and fatigue. As it has sedative effects related to blocking certain receptors in the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sleep issues are due to chronic insomnia, not another sleep disorder.

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I am 65 years old or older.

Exclusion Criteria

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

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I have Parkinson's disease.

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I am currently experiencing a psychiatric illness.

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I have fallen more than once in the past 3 months.

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I am currently taking melatonin.

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I am taking medication for insomnia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for mirtazapine and placebo group : assess the change in the insomnia severity index between the initial examination (day 1) and the end of the treatment course (day 36)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for mirtazapine and placebo group : assess the change in the insomnia severity index between the initial examination (day 1) and the end of the treatment course (day 36)

This trial's timeline: 3 weeks for screening, Varies for treatment, and for mirtazapine and placebo group : assess the change in the insomnia severity index between the initial examination (day 1) and the end of the treatment course (day 36) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Insomnia Severity Index

Pittsburgh Sleep Quality Index

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.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Mirtazapine 7.5 mg

Group II: ControlPlacebo Group1 Intervention

Matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirtazapine

FDA approved

0 / 7Eligibility 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

Chronic insomnia treatments often involve pharmacological agents that target specific neurotransmitter systems to promote sleep. Mirtazapine, for example, works by blocking histamine-1 receptors, which has a sedative effect that helps reduce sleep latency and increase total sleep time. This is particularly beneficial for chronic insomnia patients as it directly addresses difficulties in falling and staying asleep. Other common treatments include benzodiazepines and Z-drugs (e.g., zolpidem), which enhance the effect of the neurotransmitter GABA to induce sedation. However, these can have significant side effects such as cognitive impairment and risk of dependence. Melatonin, another treatment option, regulates the sleep-wake cycle and is generally well-tolerated. Understanding these mechanisms is crucial for tailoring treatment to individual patient needs and minimizing potential side effects.

Drug treatment strategies for insomnia in patients with post-traumatic stress disorder.Acute effects of mirtazapine on sleep continuity and sleep architecture in depressed patients: a pilot study.