| 1 |
NCT02484963 |
Completed |
The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia |
|
- Drug: Zolpidem
- Drug: placebo
|
Interventional
|
Not Applicable |
- Institute of Liver and Biliary Sciences, India
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time
- Precipitation of Hepatic encephalopathy with Zolpidem
- Increase in daytime sleepiness with zolpidem as measured by ESS
- (and 2 more...)
|
52 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02484963 |
ILBS-Insomnia-001 |
|
May 15, 2015 |
January 15, 2017 |
January 15, 2017 |
June 30, 2015 |
May 17, 2018 |
|
- Institute of Liver and Biliary Sciences
New Delhi, Delhi, India
|
|
| 2 |
NCT03075241 |
Recruiting |
Z-Drugs for Sleep Disorders in Alzheimer's Disease |
- Sleep
- Sleep Disorders
- Insomnia
- Alzheimer's Disease
|
- Drug: Zolpidem
- Drug: Zoplicone
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Brasilia University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Nighttime Total Sleep Time
- Daytime Total Sleep Time
- Ratio of daytime to nighttime sleep
- (and 5 more...)
|
60 |
All |
55 Years and older (Adult, Older Adult) |
NCT03075241 |
ZOLP-001 |
|
October 2016 |
October 2018 |
December 2018 |
March 9, 2017 |
August 25, 2017 |
|
- Geriatric Medical Centre
Brasilia, Distrito Federal, Brazil
|
|
| 3 |
NCT01551485 |
Unknown † |
Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement |
- Sleep Duration on the First Night After Surgery
|
- Drug: Zolpidem
- Drug: Placebo
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
|
- Change in sleep time on the first postoperative night compared to preoperatively.
|
20 |
All |
60 Years and older (Adult, Older Adult) |
NCT01551485 |
H-3-2011-022 |
|
February 2012 |
August 2012 |
October 2012 |
March 12, 2012 |
August 8, 2012 |
|
- Gentofte Hospital
Gentofte, Denmark
|
|
| 4 |
NCT00494468 |
Completed |
Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children |
|
|
Interventional
|
Phase 1
Phase 2 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sanofi-Synthelabo
|
NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety will be assessed by collection of reported adverse events or findings on physical examination or laboratory assessments.
- The primary pharmacokinetic outcome measures for this study will include the Zolpidem Cmax, Tmax, t1/2, AUC (zero to 12 hours and zero to infinity).
- Polysomnography, including an electroencephalogram, electrooculogram and electromyogram will be performed on two occasions and represents the primary pharmacodynamic outcome assessment for this study.
- (and 7 more...)
|
63 |
All |
2 Years to 18 Years (Child, Adult) |
NCT00494468 |
PPRU-10590 |
|
October 2002 |
|
March 2004 |
June 29, 2007 |
June 29, 2007 |
|
- Arkansas Children's Hospital Research Center Inc.
Little Rock, Arkansas, United States - University of California at San Diego
La Jolla, California, United States - National Jewish Medical and Research Center
Denver, Colorado, United States - (and 8 more...)
|
|
| 5 |
NCT00084669 |
Completed |
Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer |
- Breast Cancer
- Hot Flashes
- Sleep Disorders
|
- Drug: venlafaxine
- Drug: zolpidem tartrate
- Procedure: management of therapy complications
|
Interventional
|
Not Applicable |
- Massachusetts General Hospital
|
Other |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Supportive Care
|
- Sleep improvement by biologic data and actigraphy data at the end of study treatment
- Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment
|
119 |
Female |
18 Years to 65 Years (Adult, Older Adult) |
NCT00084669 |
CDR0000365502
MGH-DFCI-02311
DFCI-02311 |
|
May 2004 |
October 2007 |
March 2010 |
June 11, 2004 |
April 28, 2010 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
|
|
| 6 |
NCT01024192 |
Completed |
Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA |
|
|
Interventional
|
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improvement of the Clinical Global Impression (CGI) score
- Illness severity and average change during the study
- Pittsburgh Sleep Quality Index (PSQI) score
- (and 2 more...)
|
135 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01024192 |
ZOLPI_L_04134 |
|
November 2009 |
July 2010 |
July 2010 |
December 2, 2009 |
October 5, 2010 |
|
- Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
|
|
| 7 |
NCT01097382 |
Completed |
Sleep Satisfaction and Psychomotor Performance of Adults |
|
|
Interventional
|
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
- Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)
|
30 |
All |
21 Years and older (Adult, Older Adult) |
NCT01097382 |
ZOLPI_L_04551
U1111-1116-9105 |
MORFEO CR |
March 2010 |
April 2011 |
April 2011 |
April 1, 2010 |
July 17, 2012 |
|
- Investigational Site Number 10
Buenos Aires, Argentina - Investigational Site Number 1
C.a.b.a., Argentina - Investigational Site Number 4
C.a.b.a., Argentina - (and 3 more...)
|
|
| 8 |
NCT00530556 |
Completed |
Insomnia and Daytime Function in Osteoarthritis |
|
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Patient's Global Impression of Therapy of Insomnia
- Clinical Global Impression of Insomnia,Sleep-related outcome measures from Morning Questionnaire, Daytime Functioning Life Event Questionnaire Pain Impact Questionnaire Use of rescue medications
|
170 |
All |
45 Years and older (Adult, Older Adult) |
NCT00530556 |
L_8445 |
|
March 2003 |
June 2004 |
June 2004 |
September 17, 2007 |
February 17, 2012 |
|
|
|
| 9 |
NCT00283946 |
Completed |
A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia |
- Sleep Initiation and Maintenance Disorders
- Sleep Disorders
|
- Drug: Zolpidem MR
- Drug: Zolpidem
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean wake time after sleep onset during the double-blind period
- Mean total sleep time during the double-blind period
- Mean number of nightly awakenings during the double-blind period
- (and 3 more...)
|
876 |
All |
20 Years to 64 Years (Adult) |
NCT00283946 |
6199-CL-0007 |
|
February 2006 |
November 2007 |
November 2007 |
January 31, 2006 |
August 20, 2014 |
|
- Chubu region, Japan
- Chugoku region, Japan
- Hokkaido region, Japan
- (and 5 more...)
|
|
| 10 |
NCT00177216 |
Completed
Has Results |
Characteristics of Sleep Patterns in Young Adults With and Without Insomnia |
|
- Drug: Zolpidem
- Drug: Escitalopram
- Drug: Placebo
|
Interventional
|
Phase 4 |
- University of Pittsburgh
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Pittsburgh Sleep Quality Index
- Change in Diary Sleep Efficiency
- Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint
|
69 |
All |
20 Years to 50 Years (Adult) |
NCT00177216 |
R01MH024652
010807 |
|
February 2002 |
May 2008 |
May 2008 |
September 15, 2005 |
March 30, 2016 |
March 30, 2016 |
- Western Psychiatric Institute and Clinic/ University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
|
|
| 11 |
NCT00440323 |
Completed |
Disturbed Sleep Model Study. |
- Sleep Initiation and Maintenance Disorders
|
- Drug: SB-649868
- Drug: Zolpidem
- Drug: Placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
|
- Total Sleep Time measured overnight across four treatment sessions (4 weeks)
- The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
|
52 |
Male |
18 Years to 55 Years (Adult) |
NCT00440323 |
OXS104094 |
|
January 5, 2007 |
July 3, 2007 |
July 3, 2007 |
February 27, 2007 |
August 17, 2017 |
|
- GSK Investigational Site
Guildford, Surrey, United Kingdom
|
|
| 12 |
NCT02353299 |
Completed
Has Results |
Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers |
|
- Drug: Silenor 6 mg
- Drug: zolpidem 10 mg
- Drug: Placebo
|
Interventional
|
Phase 4 |
- Pernix Theraputics LLC
- Henry Ford Hospital
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Diagnostic
|
- Auditory Arousal Threshold (AAT) at T-max
- Tandem Walk Step-Offs
- Tandem Walk Duration Over Five Trials
- (and 4 more...)
|
52 |
Male |
21 Years to 50 Years (Adult) |
NCT02353299 |
PT-D1402 |
|
January 2015 |
January 2016 |
March 2016 |
February 2, 2015 |
January 2, 2018 |
December 7, 2017 |
- Henry Ford Hospital Sleep Disorders & Research Center
Novi, Michigan, United States
|
|
| 13 |
NCT00318448 |
Completed |
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia |
- Attention Deficit Hyperactivity Disorder
|
- Drug: Zolpidem (SL800750)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Latency to persistent sleep (LPS) measured by polysomnography
- Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)
- Actigraphy measures of sleep characteristics
- (and 4 more...)
|
201 |
All |
6 Years to 17 Years (Child) |
NCT00318448 |
EFC6820 |
Zolkids |
April 2006 |
August 2006 |
August 2006 |
April 26, 2006 |
April 7, 2009 |
|
- Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States - Sanofi-Aventis Administrative Office
Laval, Canada
|
|
| 14 |
NCT02456532 |
Recruiting |
Safety and Efficacy of Chronic Hypnotic Use 2 |
|
- Drug: placebo
- Drug: Zolpidem CR
- Drug: Eszopiclone
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- change in number capsules chosen: nightly choice of 0, 1, 2, or 3 capsules
- discontinuation difficulty: nightly choice of 0, 1, 2, or 3 capsules
- change in actigraphic determined sleep time
|
120 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02456532 |
#9384 |
CIS2 |
July 2015 |
July 2020 |
December 2020 |
May 28, 2015 |
February 23, 2017 |
|
- HFHS Sleep Disorders Ctr
Detroit, Michigan, United States
|
|
| 15 |
NCT00976105 |
Completed |
Effects of Repeat Dosing of GSK1521498 |
|
- Drug: Zolpidem or placebo - Hypnotic drug given for sleep disorders
- Drug: GSK1521498 or placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Safety and tolerability: adverse events, blood pressure, heart rate, ECG, clinical chemistry, heamatology, urinalysis, change in reaction times, change in mood scales
- Obtain benchmarking data on the cognitive and mood changes induced by a single dose of up to 10mg zolpidem
- Assess accumulation, dose proportionality and pharmacokinetics of GSK1521498: AUC (0-24), Cmax, tmax, tlag (Dose 1 only), t1/2 (Dose 10 only), trough plasma concentrations on Day 5, 7, 8, 9 and 10
- (and 2 more...)
|
49 |
All |
18 Years to 60 Years (Adult) |
NCT00976105 |
111849 |
|
September 22, 2009 |
March 9, 2010 |
March 9, 2010 |
September 14, 2009 |
June 20, 2017 |
|
- GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom
|
|
| 16 |
NCT03307005 |
Recruiting |
Improving Sleep Quality in Heart Failure |
- Sleep Disturbance
- Heart Failure
|
- Drug: Zolpidem Tartrate
- Drug: Placebo oral capsule
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
|
50 |
All |
21 Years to 79 Years (Adult, Older Adult) |
NCT03307005 |
IRB00142395 |
|
November 1, 2017 |
October 31, 2018 |
October 31, 2019 |
October 11, 2017 |
January 31, 2018 |
|
- Johns Hopkins Bayview Campus, Asthma and Allergy Center
Baltimore, Maryland, United States
|
|
| 17 |
NCT00814502 |
Completed
Has Results |
Zolpidem CR and Hospitalized Patients With Dementia |
- Dementia
- Alzheimer Disease
- Dementia, Vascular
- (and 2 more...)
|
- Drug: Zolpidem CR
- Drug: Placebo
|
Interventional
|
Not Applicable |
- Massachusetts General Hospital
- Sanofi
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Sleep Efficiency
- Sleep Minutes
- Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
|
20 |
All |
60 Years to 99 Years (Adult, Older Adult) |
NCT00814502 |
2008-P-001434/1 |
|
December 2008 |
December 2013 |
December 2013 |
December 25, 2008 |
May 22, 2017 |
May 22, 2017 |
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
|
| 18 |
NCT00044629 |
Completed |
Combined Behavioral/Pharmacological Therapy for Insomnia |
- Sleep Initiation and Maintenance Disorders
|
- Behavioral: Cognitive-Behavioral Therapy for Insomnia
- Drug: zolpidem tartrate (Ambien)
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Duke University
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
162 |
All |
21 Years to 75 Years (Adult, Older Adult) |
NCT00044629 |
Pro00011850
R01MH062119
DSIR 83-ATAS |
|
September 2001 |
|
August 2006 |
September 5, 2002 |
September 16, 2013 |
|
- Duke Sleep Disorders Center
Durham, North Carolina, United States
|
|
| 19 |
NCT01685073 |
Active, not recruiting |
The Role of Sleep in the Treatment of Cannabis Use Disorders |
|
- Drug: Zolpidem extended-release
- Behavioral: MET/CBT
|
Interventional
|
Phase 2
Phase 3 |
- Johns Hopkins University
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Sleep Efficiency
- Cannabis Abstinence
|
100 |
All |
18 Years to 55 Years (Adult) |
NCT01685073 |
NA_00068969
U01DA031784 |
|
September 2012 |
July 2018 |
July 2018 |
September 13, 2012 |
December 18, 2017 |
|
- Johns Hopkins University
Baltimore, Maryland, United States
|
|
| 20 |
NCT03269760 |
Recruiting |
Multimodal Sleep Pathway for Shoulder Arthroplasty |
- Sleep Disturbance
- Shoulder Arthritis
- Arthroplasty Complications
- Perioperative/Postoperative Complications
|
|
Interventional
|
Phase 1 |
- University of California, San Francisco
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Lead's Sleep scale
- Sleep journals
- Pain scores
|
130 |
All |
18 Years and older (Adult, Older Adult) |
NCT03269760 |
16-20346 |
|
September 1, 2017 |
September 1, 2018 |
December 31, 2018 |
September 1, 2017 |
September 1, 2017 |
|
- Ucsf
San Francisco, California, United States
|
|
| 21 |
NCT00380081 |
Completed
Has Results |
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia |
|
- Drug: zolpidem tartrate sublingual tablet 3.5mg
- Drug: zolpidem tartrate sublingual tablet 1.75mg
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Transcept Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
- Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
- Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
- (and 9 more...)
|
82 |
All |
18 Years to 64 Years (Adult) |
NCT00380081 |
ZI-06-010 |
|
April 2006 |
July 2006 |
July 2006 |
September 25, 2006 |
February 14, 2012 |
January 20, 2012 |
|
|
| 22 |
NCT00653562 |
Completed |
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography |
- Insomnia
- Sleep Initiation and Maintenance Disorders
|
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Sleep latency
- Total hours of sleep
- Frequency of intermediate awaking
- (and 2 more...)
|
11 |
All |
12 Years to 18 Years (Child, Adult) |
NCT00653562 |
6199-JC-0002 |
|
November 2006 |
March 2010 |
March 2010 |
April 7, 2008 |
February 17, 2017 |
|
- Kansai, Japan
- Kantou, Japan
- Kyusyu, Japan
- Touhoku, Japan
|
|
| 23 |
NCT00042146 |
Completed |
Behavioral and Pharmacological Treatment for Insomnia |
- Sleep Initiation and Maintenance Disorders
|
- Behavioral: Cognitive-behavior therapy
- Drug: zolpidem
|
Interventional
|
Phase 4 |
- Laval University
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
160 |
All |
30 Years and older (Adult, Older Adult) |
NCT00042146 |
R01MH060413
DATR A4-GPS |
|
December 2001 |
|
|
July 26, 2002 |
May 21, 2013 |
|
- Laval University
Quebec City, Quebec, Canada
|
|
| 24 |
NCT00466193 |
Completed
Has Results |
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia |
|
- Drug: zolpidem tartrate sublingual tablet
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Transcept Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
- Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
- Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
- (and 7 more...)
|
295 |
All |
18 Years to 64 Years (Adult) |
NCT00466193 |
ZI-12 |
|
May 2007 |
November 2007 |
November 2007 |
April 27, 2007 |
February 14, 2012 |
January 20, 2012 |
- Transcept Investigational Site
Durham, North Carolina, United States
|
|
| 25 |
NCT03436745 |
Recruiting |
The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females |
|
|
Interventional
|
Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Difference in AUC values in males between pre-ADT and post-ADT
- Comparison of AUC values between post-ADT males and healthy female subjects
|
30 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT03436745 |
180058
18-C-0058 |
|
July 24, 2018 |
December 1, 2018 |
December 1, 2018 |
February 19, 2018 |
July 19, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 26 |
NCT00688025 |
Completed |
Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia |
|
|
Observational
|
|
- Henry Ford Health System
- Takeda Pharmaceuticals North America, Inc.
|
Other / Industry |
- Time Perspective: Cross-Sectional
|
|
24 |
All |
18 Years to 55 Years (Adult) |
NCT00688025 |
07-033R |
|
May 2008 |
March 2010 |
March 2010 |
June 2, 2008 |
March 31, 2010 |
|
- Henry Ford Hospital Sleep Disorders & Research Center
Detroit, Michigan, United States
|
|
| 27 |
NCT01804036 |
Completed
Has Results |
Two Contrasting Interventions for Sleep Management |
- Primary Insomnia
- Secondary Insomnia
|
- Drug: Zolpidem
- Behavioral: Mind-Body Bridging
|
Interventional
|
Phase 2
Phase 3 |
- University of Utah
- Evans Army Community Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
- Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up
- Change in Insomnia Severity Index, From Baseline at 1-week Follow-up
- (and 11 more...)
|
72 |
All |
17 Years to 40 Years (Child, Adult) |
NCT01804036 |
IRBNet-193532-1 |
|
March 2013 |
November 2016 |
November 2016 |
March 5, 2013 |
March 30, 2017 |
March 30, 2017 |
- Evans Army Community Hospital
Colorado Springs, Colorado, United States - University of Utah
Salt Lake City, Utah, United States
|
|
| 28 |
NCT02783729 |
Completed |
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) |
|
- Drug: Lemborexant
- Drug: Lemborexant-matched placebo
- Drug: Zolpidem tartrate
- Drug: Zolpidem-matched placebo
|
Interventional
|
Phase 3 |
- Eisai Inc.
- Purdue Pharma LP
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in mean latency to persistent to sleep (LPS) of lemborexant 10 milligrams (mg) and lemborexant 5 mg compared to placebo
- Change from baseline in mean sleep efficiency (SE) of lemborexant 10 mg and lemborexant 5 mg compared to placebo for United States (US) participants only
- Change from baseline in mean wake after sleep onset (WASO) of lemborexant 10 mg and lemborexant 5 mg compared to placebo for US participants only
- (and 3 more...)
|
1006 |
All |
55 Years and older (Adult, Older Adult) |
NCT02783729 |
E2006-G000-304
2015-004347-39 |
SUNRISE 1 |
May 2016 |
January 30, 2018 |
January 30, 2018 |
May 26, 2016 |
March 21, 2018 |
|
- Jasper Summit Research LLC
Jasper, Alabama, United States - PACT
Glendale, Arizona, United States - Preferred Research Partners
Little Rock, Arkansas, United States - (and 81 more...)
|
|
| 29 |
NCT02648776 |
Enrolling by invitation |
Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly |
|
- Drug: Exposure to sedative-hypnotic drugs
|
Observational
|
|
- China Medical University Hospital
- National Health Research Institutes, Taiwan
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Changes from baseline in sleep quality at 12 months
- Number of participants with an occurrence of associated ADR
- Snapshot measurement of plasma drug and drug metabolite concentrations
- (and 15 more...)
|
1400 |
All |
65 Years and older (Older Adult) |
NCT02648776 |
DMR101-IRB1-083 |
RABA-HASDE |
January 2016 |
January 2018 |
December 2018 |
January 7, 2016 |
January 11, 2016 |
|
- China Medical University Hospital
Taichung, Taiwan
|
|
| 30 |
NCT03375203 |
Recruiting |
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder |
|
- Drug: Placebo
- Drug: JNJ-42847922, 5 mg
- Drug: JNJ-42847922, 10 mg
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1
- Change from Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1
- Change from Baseline in LPS on Night 13 of JNJ-42847922 Compared with Placebo
- (and 31 more...)
|
360 |
All |
18 Years to 85 Years (Adult, Older Adult) |
NCT03375203 |
CR108427
42847922ISM2005
2017-000980-33 |
|
November 23, 2017 |
April 24, 2019 |
April 24, 2019 |
December 15, 2017 |
July 2, 2018 |
|
- Preferred Research Partners
Little Rock, Arkansas, United States - Woodland Research Northwest
Rogers, Arkansas, United States - California Research Trials DBA Orange Country Research Institute
Anaheim, California, United States - (and 60 more...)
|
|
| 31 |
NCT00770510 |
Completed
Has Results |
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126) |
|
- Drug: Eszopiclone 1 mg
- Drug: Eszopiclone 2 mg
- Drug: Eszopiclone 3 mg
- (and 2 more...)
|
Interventional
|
Phase 2
Phase 3 |
- Eisai Co., Ltd.
- Eisai Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Latency To Persistent Sleep (LPS)
- Sleep Latency (SL)
- Total Sleep Time (Objective & Subjective)
- (and 3 more...)
|
192 |
All |
21 Years to 64 Years (Adult) |
NCT00770510 |
190-126 |
|
September 2008 |
May 2010 |
May 2010 |
October 10, 2008 |
February 4, 2013 |
February 4, 2013 |
- Toyohashi, Aichi, Japan
- Kitakyushu, Fukuoka, Japan
- Kurume, Fukuoka, Japan
- (and 17 more...)
|
|
| 32 |
NCT00893269 |
Completed |
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep |
|
- Drug: eszopiclone
- Drug: Placebo
- Drug: ramelteon
- Drug: zolpidem
|
Interventional
|
Phase 1 |
- Johns Hopkins University
- Food and Drug Administration (FDA)
- National Institute on Drug Abuse (NIDA)
|
Other / U.S. Fed / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Marijuana Withdrawal
- Objective Sleep Assessment
- Cognitive Performance
|
36 |
All |
18 Years to 55 Years (Adult) |
NCT00893269 |
NA_00017909
R21DA025794 |
|
October 2008 |
October 2010 |
October 2010 |
May 5, 2009 |
December 5, 2013 |
|
- Johns Hopkins University
Baltimore, Maryland, United States
|
|
| 33 |
NCT02671760 |
Completed
Has Results |
Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia |
|
- Drug: SM-1
- Drug: Comparator
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Sequential Medicine Ltd
- Clinilabs, Inc.
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Total Sleep Time
- Latency to Persistent Sleep
- Awakenings
- (and 3 more...)
|
39 |
All |
25 Years to 64 Years (Adult) |
NCT02671760 |
SM-A-02 |
|
February 2016 |
June 2016 |
June 2016 |
February 2, 2016 |
March 6, 2018 |
March 6, 2018 |
|
|
| 34 |
NCT00286936 |
Terminated |
Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo |
|
|
Interventional
|
Phase 4 |
- Hvidovre University Hospital
- IMK Fonden
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- Incidence and severity of postoperative delirium
- Sleep quality
- mobilization
- (and 4 more...)
|
96 |
All |
70 Years and older (Older Adult) |
NCT00286936 |
HHSG-RCT-05 |
|
February 2004 |
|
January 2007 |
February 6, 2006 |
August 30, 2011 |
|
- Hvidovre University Hospital
Hvidovre, Denmark
|
|
| 35 |
NCT00999219 |
Completed |
A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia |
- Sleep Initiation and Maintenance Disorders
|
- Drug: FK199B
- Drug: Zolpidem
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
- Mean sleep parameters estimated from polysomnography recording
- Sleep parameters estimated from sleep questionnaire
- Patient impression from sleep questionnaire
|
55 |
All |
20 Years to 65 Years (Adult, Older Adult) |
NCT00999219 |
6199-CL-0006 |
|
March 2006 |
July 2007 |
July 2007 |
October 21, 2009 |
August 20, 2014 |
|
- Chubu, Japan
- Hokkaido, Japan
- Kansai, Japan
- (and 4 more...)
|
|
| 36 |
NCT00292734 |
Completed |
STILDEP: Zolpidem in Depressive and Dysthimic Patients |
- Sleep Initiation and Maintenance Disorders
- Depression
|
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease
|
120 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00292734 |
L_9259
EudraCT # : 2004-001967-24 |
|
January 2005 |
|
June 2006 |
February 16, 2006 |
December 6, 2007 |
|
- Sanofi-Aventis
Budapest, Hungary
|
|
| 37 |
NCT02833272 |
Recruiting |
Understanding Benzodiazepine and Non-benzodiazepine Sedative Use |
- Frailty
- Deprescription
- Aged
|
- Behavioral: EMPOWER Educational Brochure
|
Interventional
|
Not Applicable |
- McGill University Health Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Stopped Use
- Sleep disturbance: sleep quality assessed by the PROMIS Sleep Disturbance 4a Short Form
- Change in patient self-reported falls
|
50 |
All |
65 Years to 120 Years (Older Adult) |
NCT02833272 |
15-372 |
|
July 2016 |
April 2017 |
June 2017 |
July 14, 2016 |
February 15, 2017 |
|
- McGill University Health Centre (Royal Victoria Hospital)
Montreal, Quebec, Canada
|
|
| 38 |
NCT00608985 |
Completed
Has Results |
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia |
|
- Drug: almorexant
- Drug: Placebo
- Drug: zolpidem
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
- Change From Baseline to Day 15&16 in WASO
- Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
- (and 3 more...)
|
709 |
All |
18 Years to 64 Years (Adult) |
NCT00608985 |
AC-057A301 |
RESTORA 1 |
March 2008 |
September 2009 |
November 2009 |
February 6, 2008 |
March 14, 2016 |
February 7, 2013 |
- Sleep Disorders Laboratory, Royal Adelaide Hospital
Adelaide, South Australia, Australia - Monash Adult Sleep Center, Monash Medical Centre
Clayton, Victoria, Australia - Western Hospitpal, Private Bag
Footscray, Victoria, Australia - (and 88 more...)
|
|
| 39 |
NCT00630175 |
Completed |
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia |
- Sleep Initiation and Maintenance Disorders
|
- Drug: zolpidem-MR (modified release)
- Drug: zolpidem (SL800750)
- Drug: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Polysommography (PSG) wake time after sleep onset (WASO)
- PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs
|
113 |
All |
18 Years to 64 Years (Adult) |
NCT00630175 |
EFC5202 |
|
September 2003 |
February 2004 |
February 2004 |
March 6, 2008 |
May 18, 2009 |
|
- Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States - Sanofi-Aventis Administrative Office
Macquarie Park, Australia - Sanofi-Aventis Administrative Office
Laval, Canada
|
|
| 40 |
NCT00956319 |
Completed |
A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients |
- Sleep Initiation and Maintenance Disorders
- Primary Insomnia
|
- Drug: Zolpidem MR
- Drug: Estazolam
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Total score of Pittsburgh Sleep Quality Index (PSQ)
- Physician's clinical global impression (CGI)
- Patient's global impression (PG)
- (and 2 more...)
|
42 |
All |
18 Years to 64 Years (Adult) |
NCT00956319 |
STCR-0802-TW |
|
May 2009 |
November 2010 |
November 2010 |
August 11, 2009 |
October 6, 2011 |
|
|
|
| 41 |
NCT01181232 |
Completed |
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients |
- Sleep Initiation and Maintenance Disorders
- Primary Insomnia
|
- Drug: Zolpidem MR
- Drug: Zolpidem IR
|
Interventional
|
Phase 4 |
- Astellas Pharma Inc
- Astellas Pharma Taiwan, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rest/activity cycles measured by Actigraphy
- Total score of Pittsburgh Sleep Quality Index (PSQI)
- Physician's clinical global impression (CGI)
- (and 6 more...)
|
132 |
All |
18 Years to 64 Years (Adult) |
NCT01181232 |
STCR-0901-TW |
|
October 2009 |
April 2011 |
April 2011 |
August 13, 2010 |
September 10, 2014 |
|
- Tainan, Taiwan
- Taipei, Taiwan
|
|
| 42 |
NCT00383643 |
Completed
Has Results |
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia. |
- Sleep Initiation and Maintenance Disorders
|
- Drug: zolpidem tartrate
- Drug: sodium oxybate
- Drug: Matching Placebos
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assessment of Clinical Global Impression-change.
- Assessment of Insomnia Severity Index
- Assessment of Pittsburgh Sleep Quality Index (PSQI)
- (and 2 more...)
|
48 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00383643 |
95900 |
|
May 2006 |
December 2009 |
December 2009 |
October 3, 2006 |
June 1, 2017 |
June 1, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
|
| 43 |
NCT00425243 |
Completed |
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG) |
- Sleep Initiation and Maintenance Disorders
|
- Drug: zolpidem-MR (SL800750)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.
- Main secondary variables are the Clinical Global Impression (CGI) improvement item and to items 2, 3, and 4 of the PGI scale at week 12.
|
1025 |
All |
18 Years to 64 Years (Adult) |
NCT00425243 |
LTE5407 |
|
August 2004 |
January 2006 |
January 2006 |
January 22, 2007 |
April 6, 2009 |
|
- Sanofi-Aventis
Malvern, Pennsylvania, United States
|
|
| 44 |
NCT00156533 |
Completed
Has Results |
Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing |
- Insomnia
- Primary Insomnia
- Psychophysiologic Insomnia
|
- Drug: Zolpidem
- Drug: Sugar Pill
|
Interventional
|
Phase 4 |
- University of Rochester
- Sanofi-Synthelabo
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Sleep Latency (SL)
- Wake After Sleep Onset (WASO)
|
20 |
All |
25 Years to 55 Years (Adult) |
NCT00156533 |
PI Initiated
11045 |
|
March 2005 |
February 2008 |
February 2008 |
September 12, 2005 |
November 20, 2015 |
May 16, 2013 |
- University of Rochester Sleep Research Laboratory
Rochester, New York, United States
|
|
| 45 |
NCT01896336 |
Unknown † |
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia |
|
- Drug: Zolpidem Hemitartrate
|
Interventional
|
Phase 4 |
- EMS
- Associação Fundo de Incentivo à Pesquisa
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy will be measured by sleep induction and maintenance.
- Safety will be evaluated by the adverse events occurrences
|
60 |
All |
20 Years to 64 Years (Adult) |
NCT01896336 |
ZPDEMS1011 |
|
February 2013 |
August 2013 |
March 2014 |
July 11, 2013 |
September 25, 2013 |
|
- AFIP
São Paulo, Sâo Paulo, Brazil
|
|
| 46 |
NCT00492232 |
Completed
Has Results |
Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia |
|
- Drug: Ramelteon and zolpidem
- Drug: Placebo and zolpidem
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Discontinued Zolpidem Therapy
- Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2
- Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4
- (and 11 more...)
|
135 |
All |
18 Years and older (Adult, Older Adult) |
NCT00492232 |
01-06-TL-375-071
U1111-1114-3262 |
|
April 2007 |
March 2008 |
May 2008 |
June 27, 2007 |
July 20, 2010 |
July 17, 2009 |
- Hot Springs, Arkansas, United States
- Anaheim, California, United States
- Fountain Valley, California, United States
- (and 38 more...)
|
|
| 47 |
NCT03160404 |
Not yet recruiting |
Zolpidem, Exercise and Insomnia |
|
- Drug: Zolpidem
- Behavioral: Exercise
- Combination Product: Zolpidem and Exercise
|
Interventional
|
Early Phase 1 |
- Universidade Federal de Goias
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Sleep onset latency (Polysomnography)
- Sleep efficiency (Polysomnography)
- Wake after sleep onset (Polysomnography)
- (and 15 more...)
|
45 |
All |
30 Years to 60 Years (Adult) |
NCT03160404 |
1.986.600 |
|
June 2017 |
May 2018 |
December 2020 |
May 19, 2017 |
May 19, 2017 |
|
|
|
| 48 |
NCT03158025 |
Recruiting |
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users |
|
- Drug: Zolpidem tablets
- Drug: Suvorexant tablets, over-encapsulated
- Drug: Lemborexant tablets
- (and 3 more...)
|
Interventional
|
Phase 1 |
- Eisai Inc.
- Purdue Pharma LP
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean peak Maximum Effect (Emax) score for Drug Liking on a Visual Analog Scale (VAS)
- Mean time to peak effect (TEmax) score for Drug Liking on a VAS
- Mean peak minimum effect (Emin) score for Drug Liking on a VAS
- (and 38 more...)
|
48 |
All |
18 Years to 55 Years (Adult) |
NCT03158025 |
E2006-A001-103 |
|
April 19, 2017 |
July 13, 2018 |
July 13, 2018 |
May 17, 2017 |
February 1, 2018 |
|
- INC Research Toronto, Inc.
Toronto, Canada
|
|
| 49 |
NCT00296179 |
Completed |
Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro |
|
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Efficacy: Patient-reported TST
- Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period
|
372 |
All |
21 Years to 64 Years (Adult) |
NCT00296179 |
PM_L_0166 |
|
February 2006 |
June 2007 |
|
February 24, 2006 |
July 28, 2008 |
|
|
|
| 50 |
NCT03331042 |
Completed |
An Investigational Study to Assess the Effectiveness and Safety of SM-1 Versus 2 Comparators and Placebo in Participants With a History of Transient Insomnia. |
|
- Drug: SM-1
- Drug: D+Z
- Drug: D+L
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Total sleep time (TST)
- Latency to persistent sleep (LPS)
- Number of awakenings (NAW)
- (and 9 more...)
|
85 |
All |
18 Years and older (Adult, Older Adult) |
NCT03331042 |
SM-A-05 |
|
October 9, 2017 |
March 20, 2018 |
March 22, 2018 |
November 6, 2017 |
March 29, 2018 |
|
- NeuroTrials Research, Inc.
Atlanta, Georgia, United States - Clinilabs, Inc.
New York, New York, United States
|
|
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