Clinical trials: Sleep Initiation and Maintenance Disorders
- Condition Sleep Initiation and Maintenance Disorders
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
- Trial name
- NCT00466193
- Testing
- zolpidem tartrate sublingual tablet
- Where
- United States
- Volunteers
- 295 people
- Sponsor
- Transcept Pharmaceuticals
Insomnia
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389).
- Trial name
- NCT00610675
- Testing
- Org 50081
- Volunteers
- 346 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Insomnia
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a…
- Trial name
- NCT00386334
- Testing
- Eszopiclone
- Where
- 82 sites in United States
- Volunteers
- 388 people
- Sponsor
- Sumitomo Pharma America, Inc.
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
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time…
- Trial name
- NCT01097616
- Testing
- Suvorexant High Dose (HD), Suvorexant Low Dose (LD)
- Volunteers
- 1,023 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia, Sleep
Frequen-ZZZ SleepPad Investigational Device POC
The investigators propose to examine the potential effects of the Frequen- ZZZ sleep pad - a noninvasive, unobtrusive appliance that generates a localized low-level electromagnetic field via radiofrequency, and that is used on…
- Conditions
- Insomnia, Sleep, Sleep Disturbance
- Trial name
- NCT05908344
- Testing
- Activated Sleep Pad system (Frequen-ZZZ), Deactivated Sleep Pad system (Frequen-ZZZ)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Kunasan Inc.
Insomnia Disorder
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
- Trial name
- NCT03679884
- Testing
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg
- Where
- 106 sites in United States, Belgium and 12 more
- Volunteers
- 804 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Sleep Initiation and Maintenance Disorders
A Study of Lemborexant in Chinese Participants With Insomnia Disorder
The primary purpose of this study is to confirm using polysomnography (PSG) that lemborexant 10 milligram (mg) is superior to placebo on objective sleep onset as assessed by latency to persistent sleep (LPS) during the last 2…
- Trial name
- NCT04549168
- Testing
- Lemborexant
- Where
- 23 sites in China, Taiwan
- Volunteers
- 194 people
- Sponsor
- Eisai Co., Ltd.
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
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
Primary Insomnia
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia.
- Trial name
- NCT01021852
- Testing
- MK-6096
- Volunteers
- 326 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia, Breast Cancer
PERSONAL - Sleep In Breast Cancer
Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals.
- Trial name
- NCT05093426
- Testing
- Stage 2 Digital sleep diary app
- Where
- United Kingdom
- Volunteers
- 226 people
- Sponsor
- Closed Loop Medicine
Insomnia
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment…
- Trial name
- NCT01021813
- Testing
- Suvorexant
- Volunteers
- 781 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Insomnia
Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo…
- Trial name
- NCT01489969
- Testing
- Neu-P11
- Where
- 9 sites in United States
- Volunteers
- 137 people
- Sponsor
- Neurim Pharmaceuticals 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
Sleep Initiation and Maintenance Disorders, Alzheimer Disease
Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)
This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep in individuals with Alzheimer's disease (AD).
- Trial name
- NCT02750306
- Testing
- Suvorexant
- Volunteers
- 285 people
- Sponsor
- Merck Sharp & Dohme LLC
Transient Insomnia
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty…
- Trial name
- NCT03331042
- Testing
- SM-1, D+Z, D+L
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- Sequential Medicine Ltd
Primary Insomnia
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
- Trial name
- RESTORA 1 (NCT00608985)
- Testing
- almorexant, zolpidem
- Where
- 91 sites in Australia, Austria and 18 more
- Volunteers
- 709 people
- Sponsor
- Midnight Pharma, LLC