Clinical trials: Sleeplessness
Insomnia
Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and…
- Trial name
- NCT01059851
- Testing
- Suvorexant
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
- Trial name
- NCT01055834
- Testing
- Eszopiclone 3 mg, Eszopiclone 1 mg
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Insomnia, Sleep-Disordered Breathing
CPAP vs ASV for Insomnia
The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
- Trial name
- P2P (NCT02365064)
- Testing
- AirCurve 10 ASV
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- ResMed
Insomnia, Major Depressive Disorder
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
- Trial name
- NCT02669082
- Testing
- Ramelteon
- Where
- 7 sites in Japan
- Volunteers
- 26 people
- Sponsor
- Takeda
Insomnia
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
- Trial name
- NCT00770692
- Testing
- Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly, Eszopiclone 3 mg- Non-elderly
- Where
- 34 sites in Japan
- Volunteers
- 369 people
- Sponsor
- Eisai Co., Ltd.
Insomnia
Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia
Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too…
- Trial name
- NCT05233761
- Testing
- Defined CBD
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Defined Research
Insomnia Disorders
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document…
- Trial name
- NCT03375203
- Testing
- JNJ-42847922, 5 mg, JNJ-42847922, 10 mg, JNJ-42847922, 20 mg
- Where
- 56 sites in United States, Belgium and 4 more
- Volunteers
- 365 people
- Sponsor
- Janssen Research & Development, LLC
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.
Insomnia Disorder
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
- Trial name
- NCT03575104
- Testing
- Daridorexant
- Where
- 86 sites in United States, Belgium and 9 more
- Volunteers
- 924 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Insomnia
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid.
- Trial name
- NCT01106859
- Testing
- zopiclone, zolpidem tartrate sublingual tablet
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Transcept Pharmaceuticals
Sleep Initiation and Maintenance Disorders
Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia
The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.
- Trial name
- NCT00756002
- Testing
- Ramelteon
- Volunteers
- 259 people
- 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
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
- Trial name
- NCT00380081
- Testing
- zolpidem tartrate sublingual tablet 3.5mg, zolpidem tartrate sublingual tablet 1.75mg
- Volunteers
- 82 people
- Sponsor
- Transcept Pharmaceuticals
Sleep Initiation and Maintenance Disorders
A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder
The primary purpose of the study is to evaluate the treatment difference between lemborexant 5 milligram (mg) (LEM5) and placebo (PBO) on latency to persistent sleep (LPS) using polysomnography (PSG) on Day 30.
- Trial name
- NCT05594589
- Testing
- Lemborexant, PBO
- Where
- 9 sites in South Korea
- Volunteers
- 65 people
- Sponsor
- Eisai Co., Ltd.
Primary Insomnia
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.
- Trial name
- NCT00770510
- Testing
- Eszopiclone 1 mg, Eszopiclone 2 mg, Eszopiclone 3 mg
- Where
- 20 sites in Japan
- Volunteers
- 192 people
- Sponsor
- Eisai Co., Ltd.
Primary Insomnia
VEC-162 Study in Adult Patients With Primary Insomnia
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
- Trial name
- NCT00548340
- Testing
- VEC-162 20 mg, VEC-162 50 mg
- Where
- 35 sites in United States
- Volunteers
- 322 people
- Sponsor
- Vanda Pharmaceuticals
Insomnia, Hepatic Insufficiency
Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy…
- Trial name
- NCT01043926
- Testing
- Suvorexant
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Major Depressive Disorder, Insomnia
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
- Trial name
- NCT03771664
- Testing
- SAGE-217
- Where
- 28 sites in United States
- Volunteers
- 87 people
- Sponsor
- Biogen
Insomnia
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries…
- Trial name
- RUBY (NCT00482612)
- Testing
- Esmirtazapine
- Volunteers
- 526 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Primary Insomnia
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.
- Trial name
- NCT00606593
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Midnight Pharma, LLC