gaboxadol has been researched along with Chronic Insomnia in 19 studies
gaboxadol: GABA agonist; inhibitor of GABA uptake systems; structure
| Excerpt | Relevance | Reference |
|---|---|---|
| "Gaboxadol was generally well tolerated over 3 months in Study 1, and over 12 months in Study 2." | 2.75 | Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. ( Anderson, D; Ceesay, P; Lines, C; Roth, T; Snavely, D; Vandormael, K, 2010) |
| "The phase advance model of transient insomnia produced significant changes in CAP parameters." | 2.75 | Alterations in cyclic alternating pattern associated with phase advanced sleep are differentially modulated by gaboxadol and zolpidem. ( Deacon, S; Ebert, B; Ferri, R; Ma, J; Ray, S; Snyder, E; Svetnik, V; Walsh, JK, 2010) |
| "Gaboxadol 15mg treatment for 2 weeks significantly improved sleep onset and maintenance variables as well as sleep quality and daytime function, as did zolpidem." | 2.74 | A 2-week efficacy and safety study of gaboxadol and zolpidem using electronic diaries in primary insomnia outpatients. ( Eglin, M; Hajak, G; Hedner, J; Loft, H; Lundahl, J; Lütolf, S; Stórustovu, SI, 2009) |
| "Gaboxadol was generally well tolerated in both studies." | 2.73 | Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. ( Corser, BC; Deacon, S; Lankford, DA; Li, Z; Lines, CR; Snavely, DB; Zheng, YP, 2008) |
| "Gaboxadol 15 mg was effective and generally well tolerated in the short-term treatment of patients with primary insomnia." | 2.73 | Effect of short-term treatment with gaboxadol on sleep maintenance and initiation in patients with primary insomnia. ( Deacon, S; Legters, A; Loft, H; Lundahl, J; Staner, C; Staner, L, 2007) |
| "Gaboxadol is a selective extrasynaptic GABA(A) agonist, previously in development for the treatment of insomniac patients." | 2.73 | Short-term treatment with gaboxadol improves sleep maintenance and enhances slow wave sleep in adult patients with primary insomnia. ( Deacon, S; Loft, H; Lundahl, J; Staner, C; Staner, L, 2007) |
| "Gaboxadol 10 and 15 mg were efficacious in significantly reducing the sleep maintenance and sleep onset disruption produced by this model of transient insomnia, with effects generally being most pronounced for the 15 mg dose." | 2.73 | Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. ( Deacon, S; Guico-Pabia, C; Martinez, R; Mayleben, D; Vandormael, K; Walsh, JK, 2008) |
| "Gaboxadol is a selective extrasynaptic GABA(A) receptor agonist previously in development for the treatment of insomnia." | 1.35 | Highway driving performance and cognitive functioning the morning after bedtime and middle-of-the-night use of gaboxadol, zopiclone and zolpidem. ( Leufkens, TR; Lund, JS; Vermeeren, A, 2009) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 12 (63.16) | 29.6817 |
| 2010's | 6 (31.58) | 24.3611 |
| 2020's | 1 (5.26) | 2.80 |
| Authors | Studies |
|---|---|
| Svetnik, V | 4 |
| Snyder, ES | 1 |
| Tao, P | 1 |
| Roth, T | 3 |
| Lines, C | 3 |
| Herring, WJ | 2 |
| Ma, J | 3 |
| Snyder, E | 2 |
| Lankford, DA | 1 |
| Corser, BC | 1 |
| Zheng, YP | 1 |
| Li, Z | 1 |
| Snavely, DB | 1 |
| Lines, CR | 1 |
| Deacon, S | 8 |
| Hajak, G | 1 |
| Hedner, J | 1 |
| Eglin, M | 1 |
| Loft, H | 3 |
| Stórustovu, SI | 1 |
| Lütolf, S | 1 |
| Lundahl, J | 5 |
| Leufkens, TR | 1 |
| Lund, JS | 1 |
| Vermeeren, A | 1 |
| Walsh, JK | 4 |
| Vandormael, K | 2 |
| Ceesay, P | 1 |
| Anderson, D | 1 |
| Snavely, D | 1 |
| Ferri, R | 1 |
| Ray, S | 2 |
| Ebert, B | 2 |
| Dijk, DJ | 2 |
| Stanley, N | 1 |
| Groeger, JA | 1 |
| Legters, A | 2 |
| Trap Huusom, AK | 1 |
| Tymofyeyev, Y | 1 |
| Maurice, D | 1 |
| Staner, L | 3 |
| Huckle, R | 1 |
| Mathias, S | 1 |
| Zihl, J | 1 |
| Steiger, A | 2 |
| Lancel, M | 1 |
| Wafford, KA | 1 |
| Staner, C | 2 |
| Orser, BA | 1 |
| Mayleben, D | 1 |
| Guico-Pabia, C | 1 |
| Martinez, R | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia[NCT00094627] | Phase 3 | 465 participants (Actual) | Interventional | 2004-11-30 | Completed | ||
| A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia[NCT00094666] | Phase 3 | 465 participants | Interventional | 2004-11-30 | Terminated | ||
| A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study B[NCT01097629] | Phase 3 | 1,020 participants (Actual) | Interventional | 2010-05-03 | Completed | ||
| A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study A[NCT01097616] | Phase 3 | 1,023 participants (Actual) | Interventional | 2010-05-05 | Completed | ||
| A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia[NCT00103818] | Phase 3 | 900 participants (Actual) | Interventional | 2005-02-28 | Completed | ||
| A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia[NCT00095069] | Phase 3 | 600 participants | Interventional | 2004-10-31 | Completed | ||
| A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia[NCT00102167] | Phase 3 | 663 participants (Actual) | Interventional | 2005-02-28 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the 3-month DB TRT Phase are counted once in this summary. (NCT01097629)
Timeframe: Up to 3 months
| Intervention | participants (Number) |
|---|---|
| Suvorexant LD | 9 |
| Suvorexant HD | 18 |
| Placebo | 17 |
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the 3-month DB TRT Phase are counted once in this summary. (NCT01097629)
Timeframe: Up to 3 months
| Intervention | participants (Number) |
|---|---|
| Suvorexant LD | 103 |
| Suvorexant HD | 189 |
| Placebo | 167 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097629)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -36.7 |
| Placebo | -24.6 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097629)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -32.2 |
| Placebo | -28.6 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097629)
Timeframe: Baseline and Night 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -34.7 |
| Placebo | -13.0 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097629)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -26.9 |
| Placebo | -14.1 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097629)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | 48.7 |
| Placebo | 22.4 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097629)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -33.7 |
| Placebo | -20.5 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097629)
Timeframe: Baseline and Week 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -19.7 |
| Placebo | -6.7 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097629)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | 62.8 |
| Placebo | 37.7 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097629)
Timeframe: Baseline and Week 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | 40.4 |
| Placebo | 14.0 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097629)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -51.9 |
| Placebo | -22.5 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097629)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -54.2 |
| Placebo | -24.8 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097629)
Timeframe: Baseline and Night 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -63.3 |
| Placebo | -21.3 |
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary. (NCT01097616)
Timeframe: Up to 3 months
| Intervention | participants (Number) |
|---|---|
| Suvorexant LD | 6 |
| Suvorexant HD | 18 |
| Placebo | 23 |
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary. (NCT01097616)
Timeframe: Up to 3 months
| Intervention | participants (Number) |
|---|---|
| Suvorexant LD | 126 |
| Suvorexant HD | 198 |
| Placebo | 191 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -34.5 |
| Placebo | -23.3 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -36.0 |
| Placebo | -26.6 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -19.1 |
| Placebo | -11.7 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | 42.6 |
| Placebo | 23.1 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -25.7 |
| Placebo | -17.3 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | 60.3 |
| Placebo | 40.6 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -45.0 |
| Placebo | -18.7 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant HD | -47.9 |
| Placebo | -25.0 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -33.6 |
| Placebo | -23.3 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -34.7 |
| Placebo | -26.6 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -17.1 |
| Placebo | -11.7 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -22.5 |
| Placebo | -17.3 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | 39.4 |
| Placebo | 23.1 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | 51.2 |
| Placebo | 40.6 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -45.0 |
| Placebo | -18.7 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Month 3
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -41.6 |
| Placebo | -25.0 |
"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Night 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -29.9 |
| Suvorexant HD | -30.6 |
| Placebo | -20.3 |
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Week 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -15.2 |
| Suvorexant HD | -15.3 |
| Placebo | -9.6 |
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period. (NCT01097616)
Timeframe: Baseline and Week 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | 28.2 |
| Suvorexant HD | 36.0 |
| Placebo | 14.6 |
"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center." (NCT01097616)
Timeframe: Baseline and Night 1
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Suvorexant LD | -52.1 |
| Suvorexant HD | -58.0 |
| Placebo | -19.6 |
4 reviews available for gaboxadol and Chronic Insomnia
| Article | Year |
|---|---|
Enhancement of slow wave sleep: implications for insomnia.
Topics: Electroencephalography; GABA Agonists; Humans; Isoxazoles; Nipecotic Acids; Sleep Deprivation; Sleep | 2009 |
Gaboxadol--a new awakening in sleep.
Topics: Animals; Benzodiazepines; Clinical Trials as Topic; Drug Interactions; Ethanol; GABA Agonists; GABA- | 2006 |
Neurochemical regulation of sleep.
Topics: Brain; Corticotropin-Releasing Hormone; Electroencephalography; Estrogens; GABA Agonists; GABA-A Rec | 2007 |
Extrasynaptic GABAA receptors are critical targets for sedative-hypnotic drugs.
Topics: Brain; GABA Agonists; Humans; Hypnotics and Sedatives; Isoxazoles; Receptors, GABA-A; Sleep Initiati | 2006 |
12 trials available for gaboxadol and Chronic Insomnia
| Article | Year |
|---|---|
Electroencephalographic power spectral density profile of the orexin receptor antagonist suvorexant in patients with primary insomnia and healthy subjects.
Topics: Adult; Aged; Azepines; Cross-Over Studies; Double-Blind Method; Electroencephalography; Female; Heal | 2014 |
Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies.
Topics: Adolescent; Adult; Age Factors; Dose-Response Relationship, Drug; Double-Blind Method; Female; GABA | 2008 |
Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies.
Topics: Adolescent; Adult; Age Factors; Dose-Response Relationship, Drug; Double-Blind Method; Female; GABA | 2008 |
Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies.
Topics: Adolescent; Adult; Age Factors; Dose-Response Relationship, Drug; Double-Blind Method; Female; GABA | 2008 |
Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies.
Topics: Adolescent; Adult; Age Factors; Dose-Response Relationship, Drug; Double-Blind Method; Female; GABA | 2008 |
A 2-week efficacy and safety study of gaboxadol and zolpidem using electronic diaries in primary insomnia outpatients.
Topics: Adolescent; Adult; Aged; Ambulatory Care; Diagnostic and Statistical Manual of Mental Disorders; Dou | 2009 |
Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies.
Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Drug-Related Side Ef | 2010 |
Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies.
Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Drug-Related Side Ef | 2010 |
Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies.
Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Drug-Related Side Ef | 2010 |
Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies.
Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Drug-Related Side Ef | 2010 |
Alterations in cyclic alternating pattern associated with phase advanced sleep are differentially modulated by gaboxadol and zolpidem.
Topics: Adolescent; Adult; Cross-Over Studies; Double-Blind Method; Female; GABA Agonists; GABA-A Receptor A | 2010 |
Enhanced slow wave sleep and improved sleep maintenance after gaboxadol administration during seven nights of exposure to a traffic noise model of transient insomnia.
Topics: Adult; Aged; Automobiles; Female; GABA-A Receptor Agonists; Humans; Isoxazoles; Male; Middle Aged; N | 2012 |
EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women.
Topics: Adolescent; Adult; Cross-Over Studies; Double-Blind Method; Electroencephalography; Female; GABA Ago | 2011 |
EEG spectral power density profiles during NREM sleep for gaboxadol and zolpidem in patients with primary insomnia.
Topics: Adolescent; Adult; Aged; Brain Waves; Cross-Over Studies; Dose-Response Relationship, Drug; Double-B | 2012 |
Effect of repeated gaboxadol administration on night sleep and next-day performance in healthy elderly subjects.
Topics: Activities of Daily Living; Aged; Attention; Cross-Over Studies; Double-Blind Method; Drug Administr | 2005 |
Effect of short-term treatment with gaboxadol on sleep maintenance and initiation in patients with primary insomnia.
Topics: Adult; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administratio | 2007 |
Short-term treatment with gaboxadol improves sleep maintenance and enhances slow wave sleep in adult patients with primary insomnia.
Topics: Adolescent; Adult; Aged; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; | 2007 |
Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial.
Topics: Adult; Dose-Response Relationship, Drug; Double-Blind Method; Female; GABA Agonists; Humans; Isoxazo | 2008 |
3 other studies available for gaboxadol and Chronic Insomnia
| Article | Year |
|---|---|
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?
Topics: Age Factors; Analgesics; Azepines; Female; Humans; Isoxazoles; Male; Middle Aged; Polysomnography; P | 2020 |
Highway driving performance and cognitive functioning the morning after bedtime and middle-of-the-night use of gaboxadol, zopiclone and zolpidem.
Topics: Adult; Affect; Arousal; Attention; Automobile Driving; Azabicyclo Compounds; Cognition; Cross-Over S | 2009 |
Gaboxadol. Lundbeck/Merck.
Topics: Animals; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Dogs; Drug Evaluat | 2004 |