Trial Outcomes & Findings for Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia (NCT NCT03774810)
NCT ID: NCT03774810
Last Updated: 2025-05-09
Results Overview
Tracking treatment response via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
1 Month
Results posted on
2025-05-09
Participant Flow
197 subjects were consented and enrolled into baseline.
7 subjects were lost to follow-up. 13 subjects withdrew during baseline. 28 did not meet criteria for Insomnia based on baseline sleep diaries. 34 were screened out for sleep apnea. 115 continued to phase 1 of treatment
Participant milestones
| Measure |
QHS-FD (Phase 1)
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Phase 1
STARTED
|
115
|
0
|
0
|
0
|
0
|
|
Phase 1
COMPLETED
|
83
|
0
|
0
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
32
|
0
|
0
|
0
|
0
|
|
Phase 2 (3 Months)
STARTED
|
0
|
22
|
18
|
23
|
20
|
|
Phase 2 (3 Months)
COMPLETED
|
0
|
13
|
14
|
17
|
18
|
|
Phase 2 (3 Months)
NOT COMPLETED
|
0
|
9
|
4
|
6
|
2
|
|
Phase 3 (9-month Extension of Phase 2)
STARTED
|
0
|
13
|
14
|
17
|
18
|
|
Phase 3 (9-month Extension of Phase 2)
COMPLETED
|
0
|
9
|
9
|
10
|
12
|
|
Phase 3 (9-month Extension of Phase 2)
NOT COMPLETED
|
0
|
4
|
5
|
7
|
6
|
Reasons for withdrawal
| Measure |
QHS-FD (Phase 1)
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Phase 1
Lack of Efficacy
|
21
|
0
|
0
|
0
|
0
|
|
Phase 1
Withdrawal by Subject
|
9
|
0
|
0
|
0
|
0
|
|
Phase 1
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
|
Phase 2 (3 Months)
Lack of Efficacy
|
0
|
3
|
2
|
3
|
1
|
|
Phase 2 (3 Months)
Withdrawal by Subject
|
0
|
5
|
2
|
3
|
1
|
|
Phase 2 (3 Months)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Phase 3 (9-month Extension of Phase 2)
Lack of Efficacy
|
0
|
3
|
2
|
1
|
2
|
|
Phase 3 (9-month Extension of Phase 2)
Withdrawal by Subject
|
0
|
1
|
3
|
5
|
2
|
|
Phase 3 (9-month Extension of Phase 2)
Withdrawn by PI due to study end.
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
Baseline characteristics by cohort
| Measure |
QHS-FD (Phase 1)
n=115 Participants
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
1 active doses/week with 6 placebos interspersed between active doses.
Active Doses: zolpidem tartrate 5 mg (males 60+ years of age, all females) or 10 mg (males 40-59 years of age).
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
3 active doses/week with 4 placebos interspersed between active doses.
Active Doses: zolpidem tartrate 5 mg (males 60+ years of age, all females) or 10 mg (males 40-59 years of age).
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
1-3 active doses per week, on night(s) chosen by participant (as needed).
Active Doses: zolpidem tartrate 5 mg (males 60+ years of age, all females) or 10 mg (males 40-59 years of age).
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
Nightly active dose (QHS).
Active Doses: zolpidem tartrate 5 mg (males 60+ years of age, all females) or 10 mg (males 40-59 years of age).
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
—
|
—
|
—
|
—
|
56.6 years
STANDARD_DEVIATION 8.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
87 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
113 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
100 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
115 participants
n=10 Participants
|
|
Sleep Continuity
Sleep Latency
|
31.71 Minutes
STANDARD_DEVIATION 42.98 • n=5 Participants
|
—
|
—
|
—
|
—
|
31.71 Minutes
STANDARD_DEVIATION 42.98 • n=10 Participants
|
|
Sleep Continuity
Wake After Sleep Onset
|
50.54 Minutes
STANDARD_DEVIATION 50.54 • n=5 Participants
|
—
|
—
|
—
|
—
|
50.54 Minutes
STANDARD_DEVIATION 47.67 • n=10 Participants
|
|
Sleep Continuity
Early Morning Awakenings
|
74.9 Minutes
STANDARD_DEVIATION 56.84 • n=5 Participants
|
—
|
—
|
—
|
—
|
74.79 Minutes
STANDARD_DEVIATION 56.84 • n=10 Participants
|
PRIMARY outcome
Timeframe: 1 MonthPopulation: All subjects received the same treatment for phase 1, so none were randomized to other conditions.
Tracking treatment response via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings).
Outcome measures
| Measure |
QHS-FD (Phase 1)
n=115 Participants
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg. Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Treatment Response (Phase 1)
|
94 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: This outcome only includes phase 2, so, by definition the phase 1 group had no subjects.
Tracking relapse via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings).
Outcome measures
| Measure |
QHS-FD (Phase 1)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
n=22 Participants
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
n=18 Participants
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
n=23 Participants
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
n=20 Participants
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg. Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Insomnia Relapse (Phase 2)
|
—
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: This outcome only includes phase 3, so, by definition the phase 1 group had no subjects.
Tracking relapse via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings).
Outcome measures
| Measure |
QHS-FD (Phase 1)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
n=13 Participants
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
n=14 Participants
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
n=17 Participants
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
n=18 Participants
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg. Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Insomnia Relapse (Phase 3)
|
—
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: This outcome only includes phase 1, so, by definition the groups for phases 2 and 3 had no subjects.
Assess sleep continuity by assessing daily sleep diary responses.
Outcome measures
| Measure |
QHS-FD (Phase 1)
n=115 Participants
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg. Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Sleep Continuity (Phase 1)
Sleep Latency (SL)
|
17.35 Minutes
Standard Deviation 26.09
|
—
|
—
|
—
|
—
|
|
Sleep Continuity (Phase 1)
Wake After Sleep Onset (WASO)
|
29.46 Minutes
Standard Deviation 34.82
|
—
|
—
|
—
|
—
|
|
Sleep Continuity (Phase 1)
Early Morning Awakenings (EMA)
|
69.07 Minutes
Standard Deviation 52.45
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This outcome only includes phase 2, so, by definition the phase 1 group had no subjects.
Assess sleep continuity by assessing daily sleep diary responses.
Outcome measures
| Measure |
QHS-FD (Phase 1)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
n=22 Participants
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
n=18 Participants
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
n=23 Participants
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
n=20 Participants
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg. Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Sleep Continuity (Phase 2)
Sleep Latency (SL)
|
—
|
21.24 Minutes
Standard Deviation 26.51
|
24.56 Minutes
Standard Deviation 45.02
|
21.76 Minutes
Standard Deviation 31.38
|
13.03 Minutes
Standard Deviation 20.37
|
|
Sleep Continuity (Phase 2)
Wake After Sleep Onset (WASO)
|
—
|
37.51 Minutes
Standard Deviation 39.07
|
44.29 Minutes
Standard Deviation 50.74
|
34.20 Minutes
Standard Deviation 38.31
|
22.78 Minutes
Standard Deviation 28.46
|
|
Sleep Continuity (Phase 2)
Early Morning Awakenings (EMA)
|
—
|
64.77 Minutes
Standard Deviation 51.79
|
69.88 Minutes
Standard Deviation 57.33
|
65.61 Minutes
Standard Deviation 52.56
|
53.52 Minutes
Standard Deviation 36.06
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: This outcome only includes phase 3, so, by definition the phase 1 group had no subjects.
Assess sleep continuity by assessing daily sleep diary responses.
Outcome measures
| Measure |
QHS-FD (Phase 1)
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
n=13 Participants
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
n=14 Participants
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
n=17 Participants
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
n=18 Participants
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg. Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Sleep Continuity (Phase 3)
Sleep Latency (SL)
|
—
|
20.32 Minutes
Standard Deviation 27.51
|
29.71 Minutes
Standard Deviation 52.42
|
24.32 Minutes
Standard Deviation 35.00
|
11.43 Minutes
Standard Deviation 14.09
|
|
Sleep Continuity (Phase 3)
Wake After Sleep Onset (WASO)
|
—
|
34.73 Minutes
Standard Deviation 38.33
|
38.10 Minutes
Standard Deviation 42.09
|
37.80 Minutes
Standard Deviation 41.00
|
21.25 Minutes
Standard Deviation 28.10
|
|
Sleep Continuity (Phase 3)
Early Morning Awakenings (EMA)
|
—
|
59.34 Minutes
Standard Deviation 44.21
|
79.12 Minutes
Standard Deviation 68.48
|
62.68 Minutes
Standard Deviation 48.73
|
50.19 Minutes
Standard Deviation 36.49
|
Adverse Events
QHS-FD (Phase 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
QHS-FD (Phase 1)
n=115 participants at risk
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg. Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 1 (PR1) (Phases 2 & 3)
n=22 participants at risk
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Partial Reinforcement 3 (PR3) (Phases 2 & 3)
n=18 participants at risk
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3)
n=23 participants at risk
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men 60 and older and women of all ages. 10 mg for men younger than 60.
|
Full Dose Nightly (QHS-FD) (Phases 2 & 3)
n=20 participants at risk
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Zolpidem tartrate: Zolpidem Tartrate, 5mg for men older than 60 and women of all ages. 10 mg for men younger than 60.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Brain Fog
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Nervous system disorders
Dizziness
|
0.87%
1/115 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
4.3%
1/23 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Nervous system disorders
Daytime Sleepiness
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
4.3%
1/23 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Nervous system disorders
Headache
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Eye disorders
Peripheral Scotomas
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Musculoskeletal and connective tissue disorders
Torn anterior cruciate ligament
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Cardiac disorders
Heart Palpitations
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Nervous system disorders
Jitteriness
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Nervous system disorders
Ocular Migraine
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Nervous system disorders
Hypnic Jerks
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/18 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Gastrointestinal disorders
Stomach Aches/Nausea
|
0.87%
1/115 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
11.1%
2/18 • Number of events 2 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
General disorders
Chest Discomfort
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Psychiatric disorders
Panic Attacks
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
General disorders
Dry Mouth
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Psychiatric disorders
Worsening Mood
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
|
Nervous system disorders
Phantosmia
|
0.00%
0/115 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/22 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
5.6%
1/18 • Number of events 1 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/23 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
0.00%
0/20 • Adverse event data was collected over a period of 13 months per subject.
No serious adverse events occurred.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place