Clinical trials: Sleeplessness
Insomnia, Sleep Initiation and Maintenance Disorders
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
- Trial name
- NCT00653562
- Testing
- zolpidem
- Where
- 4 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Astellas Pharma Inc
Insomnia
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
- Trial name
- NCT02455271
- Testing
- Eszopiclone
- Where
- 2 sites in Japan
- Volunteers
- 438 people
- Sponsor
- Eisai Co., Ltd.
Sleep Initiation and Maintenance Disorders, Pregnancy
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with…
- Trial name
- NCT06744673
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 861 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Insomnia
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
- Trial name
- NCT06498128
- Testing
- Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Insomnia Disorder
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
- Trial name
- NCT06393504
- Testing
- Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication
- Where
- United States
- Volunteers
- 2,095 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Insomnia Disorder
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.
- Trial name
- NCT06953869
- Testing
- Tasimelteon Oral Suspension
- Where
- 35 sites in United States, Germany and 2 more
- Volunteers
- 420 people
- Sponsor
- Vanda Pharmaceuticals
Insomnia
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and…
- Trial name
- NCT00914862
- Testing
- Ramelteon
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Takeda
Insomnia
Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.
- Trial name
- NCT02153086
- Testing
- Ramelteon
- Where
- 2 sites in Japan
- Volunteers
- 236 people
- Sponsor
- Takeda
Insomnia
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.
- Trial name
- NCT02058992
- Testing
- Ramelteon
- Volunteers
- 3,339 people
- Sponsor
- Takeda
Insomnia
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
- Trial name
- NCT00432198
- Testing
- Zolpidem (Myslee®)
- Where
- 7 sites in Japan
- Volunteers
- 122 people
- Sponsor
- Astellas Pharma Inc
Attention Deficit Hyperactivity Disorder
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of…
- Trial name
- Zolkids (NCT00318448)
- Testing
- Zolpidem (SL800750)
- Where
- 2 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- Sanofi
Sleep Initiation and Maintenance Disorders
A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.
The purpose of the study is to evaluate the incidence of somnolence, parasomnia, narcoleptic symptoms, and suicidal ideation/suicidal behavior after administration of lemborexant (DAYVIGO) in daily practice.
- Trial name
- NCT04573556
- Testing
- Lemborexant
- Where
- 3 sites in Japan
- Volunteers
- 550 people
- Sponsor
- Eisai Co., Ltd.
Insomnia, Attention Deficit Hyperactivity Disorder
Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
- Trial name
- NCT00857220
- Testing
- eszopiclone
- Where
- 89 sites in United States
- Volunteers
- 304 people
- Sponsor
- Sumitomo Pharma America, Inc.
Diabetes Mellitus, Type 2, Insomnia
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied…
- Trial name
- NCT00869128
- Testing
- Circadin
- Volunteers
- 36 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Insomnia
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder.
- Trial name
- NCT05423717
- Testing
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg
- Where
- 35 sites in United States, Bulgaria and 4 more
- Volunteers
- 166 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Insomnia, Attention Deficit Hyperactivity Disorder
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention…
- Trial name
- NCT00856973
- Testing
- eszopiclone
- Where
- 73 sites in United States
- Volunteers
- 486 people
- Sponsor
- Sumitomo Pharma America, Inc.
Autism Spectrum Disorder
Efficacy and Safety of Slenyto for Insomnia in Children With ASD
This is a randomized placebo controlled study in children diagnosed with autism spectrum disorder (ASD), to Investigate the Efficacy and Safety of Slenyto® to alleviate Sleep Disturbances in these children. .
- Trial name
- ASD (NCT04233502)
- Testing
- Melatonin
- Sponsor
- Neurim Pharmaceuticals Ltd.
Sleep Initiation and Maintenance Disorders
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage…
- Trial name
- PKiDs (NCT00913614)
- Testing
- Eplivanserin (SR46349)
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Sanofi
Insomnia
Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.
- Trial name
- NCT02452684
- Testing
- Eszopiclone
- Where
- 2 sites in Japan
- Volunteers
- 4,876 people
- Sponsor
- Eisai Co., Ltd.
Transient Insomnia
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
- Trial name
- NCT00666575
- Testing
- Gabapentin
- Where
- 23 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.