Clinical Trials for Insomnia: Current Research and Treatment Options
There are currently 13 ongoing clinical trials investigating new treatments for insomnia, a sleep disorder affecting millions of people worldwide. These studies are testing various approaches including new medications, hormone therapies, light therapy, and psychological interventions across multiple countries in Europe. Researchers are examining how these treatments can improve sleep quality, reduce the time it takes to fall asleep, and enhance daytime functioning for people struggling with sleep difficulties.
Clinical trial locations
- Bulgaria
- Denmark
- Finland
- France
- Germany
- Study on Neurexan for Improving Sleep in Patients with Short-Term Insomnia
- Study to Determine Safe and Effective Dose of Daridorexant for Treating Insomnia in Children and Adolescents Aged 10 to 18 Years
- Study of tasimelteon compared to placebo for treating insomnia in children
- Study on Daridorexant for Treating Insomnia in Patients with Insomnia and Nocturia
- Study on the Effects of Tasipimidine for Patients with Insomnia Disorder
- Study on the Effectiveness and Safety of AV-EC2023 Tablets for Adults with Insomnia
- Italy
- Netherlands
- Study on the Effect of Cannabidiol (CBD) on Sleep Quality in Multiple Sclerosis Patients with Insomnia
- Study on Amitriptyline and Cognitive Behavioral Therapy for Patients with Chronic Insomnia and Medical Conditions
- Study on the Effects of Estradiol, Progesterone, and Online Sleep Therapy for Insomnia and Menopausal Symptoms in Perimenopausal Women
- Poland
- Spain
Study of Daridorexant for Treating Insomnia in Patients with Mild Cognitive Impairment and Mild to Moderate Alzheimer’s Disease
This trial in France is studying daridorexant, a medication designed to help people who have trouble sleeping and also suffer from mild cognitive impairment or mild to moderate Alzheimer’s disease. The study examines whether daridorexant can increase total sleep time and improve sleep quality in this specific patient population.
Main inclusion criteria: Participants must be between 60 and 85 years old and experiencing sleep difficulties at least three nights per week for at least three months. Their estimated total sleep time should be less than six hours on at least three nights weekly, and they must score 15 or higher on the Insomnia Severity Index. A sleep study must confirm total sleep time of less than six hours and wake time after sleep onset of more than one hour. Participants must have a diagnosis of mild cognitive impairment or early-stage Alzheimer’s disease with specific brain changes, a Mini-Mental State Examination score between 12 and 26, and a Clinical Dementia Rating score between 0.5 and 2.
Main exclusion criteria: People with sleep disorders other than the type being studied, severe forms of Alzheimer’s disease, those outside the specified age range, individuals unable to provide consent, those with certain medical conditions that might interfere with results, participants in other clinical trials, those with substance abuse history, pregnant or breastfeeding women, and people with allergies to the study medication cannot participate.
Study focus: The research evaluates how daridorexant affects total sleep time using specialized sleep monitoring equipment called polysomnography. The study also tracks changes in mood, memory, and overall quality of life. Participants take the medication in tablet form daily, and their sleep patterns are monitored throughout the treatment period.
Investigational drug: Daridorexant works by targeting specific brain receptors involved in the sleep-wake cycle, helping to promote better sleep in people with cognitive conditions.
Study on Melatonin and Low-Dose Quetiapine for Patients with Psychiatric Disorders and Insomnia
This Danish trial compares the effectiveness of melatonin and low-dose quetiapine against a placebo in treating people who have both psychiatric disorders and sleep difficulties. The study runs for six months and aims to determine which treatment works best when added to usual care.
Main inclusion criteria: Participants must be between 18 and 64 years old with a current or past diagnosis of specific mental or behavioral disorders. They must experience sleep difficulties at least three times weekly for the past three months and score 11 or higher on the Insomnia Severity Index. Women who can become pregnant must have a negative pregnancy test and use effective birth control.
Main exclusion criteria: The trial excludes patients with psychiatric disorders such as schizophrenia, mood disorders, or autism spectrum disorders, as well as those experiencing chronic sleep problems.
Study focus: Researchers monitor the severity of participants’ sleep problems and overall well-being using various assessment scales. The study tracks sleep quality, daytime functioning, and any side effects throughout the six-month period.
Investigational drugs: Melatonin is a natural hormone that helps regulate the sleep-wake cycle, taken as a 3 mg tablet. Quetiapine, typically used for mental health conditions, is tested at a low 25 mg dose to see if it can improve sleep while supporting mental health treatment.
Study on Neurexan for Improving Sleep in Patients with Short-Term Insomnia
This German study tests whether Neurexan, a tablet containing natural ingredients, can improve sleep efficiency in people experiencing short-term sleep problems lasting less than three months.
Main inclusion criteria: Participants must have short-term sleep difficulties as defined by specific medical criteria, with moderate symptoms scoring between 8 and 22 on the Insomnia Severity Index for at least one week but not longer than three months. They must be between 18 and 65 years old, have a usual bedtime between 9 PM and 1 AM, spend 6 to 9 hours in bed nightly, and have a Body Mass Index between 18.5 and 29.9. Participants must be able to use digital devices and speak German.
Main exclusion criteria: People with other sleep disorders, serious medical conditions affecting sleep, those taking sleep-related medications, individuals with drug or alcohol abuse history, pregnant or breastfeeding women, recent participants in other clinical trials, and those with known allergies to the study medication cannot join.
Study focus: The trial monitors sleep efficiency using polysomnography, which records brain waves and other sleep data. Researchers also assess daytime performance and stress levels through both scientific measurements and participant feedback.
Investigational drug: Neurexan contains natural ingredients including zincum isovalerianicum, coffea arabica, passiflora incarnata, and avena sativa, which are used in homeopathic medicine to help with sleep and stress.
Study on the Effect of Cannabidiol (CBD) on Sleep Quality in Multiple Sclerosis Patients with Insomnia
This Dutch trial, called the CanISleepinMS Study, investigates whether cannabidiol (CBD) oil can improve sleep quality in people with multiple sclerosis who experience sleep difficulties. The study involves 15 individual trials where participants receive either CBD oil or a placebo.
Main inclusion criteria: Participants must have a neurologist-confirmed diagnosis of multiple sclerosis with long-term sleep problems diagnosed as sleep disorder by both an MS neurologist and sleep specialist. They must have relapsing-remitting, primary progressive, or secondary progressive MS with an Expanded Disability Status Scale score less than 7.5. Participants must be at least 18 years old with a Body Mass Index below 35.0, willing to maintain stable medications and lifestyle, avoid cannabis products and sleep supplements during the study, and not drive within 8 hours of taking the study product.
Main exclusion criteria: The trial excludes people not experiencing sleep problems or not diagnosed with multiple sclerosis, those younger than 18 or older than 65, and individuals from vulnerable populations.
Study focus: Researchers use a mobile app to track sleep patterns and conduct assessments using questionnaires like the Insomnia Severity Index. The study measures how long it takes to fall asleep, number of nighttime awakenings, and total sleep time.
Investigational drug: Cannabidiol (CBD) is a compound from the cannabis plant known for its calming effects. The study uses Clinican CBD 10% oil, taken by mouth and absorbed through mouth tissues.
Study to Determine Safe and Effective Dose of Daridorexant for Treating Insomnia in Children and Adolescents Aged 10 to 18 Years
This international trial across Bulgaria, Spain, Germany, and Italy studies which dose of daridorexant is safe and effective for treating sleep difficulties in young people aged 10 to under 18 years. The study tests two doses (25 mg and 50 mg) against a placebo for up to 20 days.
Main inclusion criteria: Participants must be between 10 and 18 years old with chronic sleep difficulties persisting for at least three months, occurring at least three nights weekly. Their caregiver must provide signed informed consent, and the child must provide written agreement if old enough. The sleep problem must affect daytime activities and not be caused by medications. Participants must score above a certain threshold on a sleep disturbance questionnaire and meet specific sleep time criteria during screening tests.
Main exclusion criteria: The study cannot include patients with psychiatric disorders such as schizophrenia, mood disorders, or autism spectrum disorders, or those experiencing chronic sleep problems.
Study focus: The research uses polysomnography to measure changes in total sleep time from baseline. Participants are monitored throughout the treatment period to ensure safety and effectiveness.
Investigational drug: Daridorexant is taken by mouth and works by blocking orexin receptors, which play a role in wakefulness, thereby promoting sleep.
Study of Light Therapy and Melatonin for Treatment of Major Depressive Episode with Insomnia
This French study examines the effectiveness of light therapy and melatonin, used together or separately, for treating patients experiencing both major depression and sleep difficulties. The research runs for eight weeks with a three-month follow-up.
Main inclusion criteria: Participants must be between 18 and 65 years old with a diagnosis of major depressive episode scoring at least 20 points on the MADRS depression scale and sleep problems scoring at least 8 points on the ISI sleep scale. They must not have taken antidepressant medications or undergone light therapy in the past month and must be able to participate in treatment for eight weeks.
Main exclusion criteria: People with bipolar disorder history, current psychotic symptoms, recent antidepressant medication changes within four weeks, shift work or irregular sleep schedules, severe eye conditions, known melatonin allergies, pregnancy or breastfeeding, severe liver or kidney problems, current participation in other trials, seizure history, unstable medical conditions, substance abuse within six months, severe sleep apnea, or inability to follow study procedures cannot participate.
Study focus: Participants are divided into four groups receiving different combinations of melatonin tablets (2 mg prolonged-release) or placebo, along with either active light therapy or its alternative. Researchers evaluate depression symptoms and sleep quality at regular intervals.
Investigational treatments: Light therapy involves exposure to bright artificial light at specific times to regulate the sleep-wake cycle. Melatonin is a hormone that helps regulate sleep patterns, provided in prolonged-release tablet form to maintain consistent levels throughout the night.
Study of tasimelteon compared to placebo for treating insomnia in children
This trial in Germany and Poland studies tasimelteon, given as a liquid medication, to see if it helps children and teenagers fall asleep more quickly. The study runs for 12 months with participants taking their assigned medication daily based on body weight, not exceeding 20 milligrams per day.
Main inclusion criteria: Participants must be between 2 and 17 years old with confirmed sleep difficulties taking at least one hour to fall asleep on average four nights per week for at least three months. Documentation in a sleep diary must show taking one hour or more to fall asleep at least three nights weekly in the four weeks before starting the study. Parent or legal guardian consent and child’s agreement to participate are required, along with completion of a daily sleep diary for at least five out of seven nights during screening.
Main exclusion criteria: The study excludes people under 18 years old, those with sleep apnea or narcolepsy history, night shift workers, individuals using sleep-affecting medications in the past two weeks, current sleep medication users, those with substance abuse history, severe psychiatric conditions, pregnancy or breastfeeding, participation in other trials within 30 days, significant medical conditions, known allergies to the medication, irregular sleep schedules, and excessive caffeine consumption.
Study focus: Researchers collect information through daily sleep diaries and use a special device called an actigraph to record sleep-wake patterns. The main focus is measuring how long it takes participants to fall asleep, along with overall sleep quality and daytime functioning.
Investigational drug: Tasimelteon works by regulating the body’s natural sleep-wake cycle, mimicking the effects of melatonin, a natural hormone controlling sleep patterns.
Study on Amitriptyline and Cognitive Behavioral Therapy for Patients with Chronic Insomnia and Medical Conditions
This Dutch trial tests whether low-dose amitriptyline is as effective as cognitive behavioral therapy for treating chronic sleep difficulties in people who also have other medical conditions. The study lasts 12 weeks.
Main inclusion criteria: Adults aged 18 to 85 years with sleep difficulties according to specific medical criteria, experiencing sleep problems at least three nights weekly for at least three months with effects on daytime activities. Participants must score 10 or higher on the Insomnia Severity Index and have a medical condition or chronic pain lasting more than three months.
Main exclusion criteria: Patients not experiencing chronic sleep problems, those outside the specified age range, and individuals from vulnerable populations cannot participate.
Study focus: The trial monitors changes in sleep quality and daytime functioning throughout the 12-week period. Participants keep sleep diaries to record patterns and any side effects, with the primary focus on insomnia severity scores at 12 weeks.
Investigational treatments: Amitriptyline, typically used for depression, is tested in a low dose (10-20 mg) to help improve sleep. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a talk therapy teaching new habits and relaxation techniques to improve sleep over time.
Study on Daridorexant’s Effect on Cognitive Performance in Patients with Chronic Insomnia Disorder
This Italian study examines how daridorexant affects cognitive performance, such as attention and memory, in people with chronic sleep difficulties. The research monitors changes over six months with visits at three and six months.
Main inclusion criteria: Participants must be between 18 and 65 years old with a diagnosis of chronic sleep difficulties and starting daridorexant at 50 mg per day according to approved instructions. They must be willing and able to give written informed consent, understand the study purpose including possible risks and side effects, and follow study requirements.
Main exclusion criteria: People not diagnosed with chronic sleep problems, those under 18 years old, individuals from vulnerable populations, those unwilling to follow study procedures, current participants in other trials, people with known allergies to the medication, and those with medical conditions making participation unsafe cannot join.
Study focus: The trial assesses changes in sleep efficiency and cognitive performance through neuropsychological tests and questionnaires at three and six-month follow-up visits.
Investigational drug: Daridorexant is taken once daily as a 50 mg film-coated tablet and works by blocking certain brain receptors that promote wakefulness, helping regulate the sleep-wake cycle.
Study on the Effectiveness and Safety of AV-EC2023 Tablets for Adults with Insomnia
This German trial tests Escholzia tablets, a newly developed medication, comparing it to a placebo. The study has two phases: a one-month initial phase followed by a two-month extended phase where all participants receive the active treatment.
Main inclusion criteria: Participants must be between 18 and 65 years old with a diagnosis of sleep difficulties, scoring greater than 7 on the Insomnia Severity Index. They must have usual bedtime between 9 PM and midnight, easy internet access for filling out a daily electronic diary, and freezing capabilities for storing saliva samples.
Main exclusion criteria: People not diagnosed with sleep problems, those under 18 years old, individuals from vulnerable populations, those unable to follow study procedures, people with interfering medical conditions, those taking medications affecting study results, pregnant or breastfeeding women, individuals with substance abuse history, and recent participants in other trials cannot join.
Study focus: Participants maintain daily sleep diaries and wear actigraph devices measuring sleep quantity and patterns. Researchers assess various aspects including how long it takes to fall asleep, number of nighttime awakenings, and total sleep time. Saliva samples measure stress and sleep readiness indicators.
Investigational drug: Escholzia tablets are taken orally once daily and are being studied for their effectiveness in improving sleep quality and safety in treating adults with sleep difficulties.
Study on the Effects of Estradiol, Progesterone, and Online Sleep Therapy for Insomnia and Menopausal Symptoms in Perimenopausal Women
This Dutch study examines how hormone therapy combined with online sleep therapy can help with sleep problems and menopausal symptoms in women transitioning toward menopause. The research lasts several months with assessments at different stages.
Main inclusion criteria: Women aged between 40 and 55 years with an Insomnia Severity Index score of 10 or higher and a Green Climacteric Score of 13 or higher. Participants must feel confident completing online questionnaires and diaries in Dutch and English and have had a menstrual cycle within the past year.
Main exclusion criteria: Men, individuals not experiencing sleep problems or menopausal symptoms, people not in the perimenopausal stage, and those from vulnerable populations cannot participate.
Study focus: The trial evaluates the effectiveness of hormone therapy using Systen 50 transdermal patches delivering estradiol and Utrogestan capsules containing progesterone, combined with guided online cognitive behavioral therapy for sleep difficulties. Researchers monitor changes in sleep patterns, mood, and menopausal symptoms over a four-month period.
Investigational treatments: Hormone therapy replaces hormones the body no longer produces after menopause to improve overall well-being. The guided online cognitive behavioral therapy helps individuals change thoughts and behaviors causing sleep problems.
More trials are available beyond these ten detailed descriptions. Interested patients should consult with their healthcare providers about trial eligibility and participation options.
Summary
The 13 ongoing clinical trials for sleep difficulties represent a diverse range of treatment approaches being studied across Europe. Germany leads with six trials, reflecting significant research investment in this country. The Netherlands follows with three trials, while France, Spain, Poland, Finland, Italy, Bulgaria, and Denmark each host between one and two studies.
Several medications appear multiple times across different trials, with daridorexant being the most frequently studied compound, appearing in four separate trials targeting different patient populations including children, older adults with cognitive impairment, and people with nighttime urination. This suggests strong research interest in this particular medication’s potential benefits.
The trials demonstrate increasing recognition that sleep difficulties often occur alongside other health conditions. Several studies specifically target people with complex health situations, such as those with multiple sclerosis, psychiatric disorders, Alzheimer’s disease, chronic pain, or menopausal symptoms. This reflects a more realistic approach to treating sleep problems as they actually occur in everyday life.
Notably, two trials focus specifically on children and adolescents, addressing an important gap in sleep treatment research for younger age groups. The inclusion of both medication and non-medication approaches, such as cognitive behavioral therapy and light therapy, provides patients and doctors with a broader range of potential treatment options.
The variety of assessment methods used across these trials, including advanced sleep monitoring equipment, daily diaries, and quality-of-life questionnaires, demonstrates thorough scientific approaches to understanding how treatments affect not just sleep duration but overall daily functioning and well-being.
