Trial Outcomes & Findings for Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing (NCT NCT00156533)

Results Overview

Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline and Post-treatment (12wks)

Results posted on

2015-11-20

Participant Flow

Subjects recruited from television and newspaper ads. After a telephone or web based screening, subjects brought into the lab to read the Informed Consent Form (ICF). After the ICF has been signed, an initial medical and psychiatric evaluation completed. If the subjects remain eligible they are required to keep two weeks of sleep diaries.

Participant milestones

Participant milestones
Measure	Placebo Once nightly dosing (quaque hora somni \[QHS\])with placebo	QHS (Nightly) Zolpidem Once nightly (QHS) dosing with 10mg of zolpidem	Intermittant Zolpidem Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed	CTRL Monitor only condition.
Overall Study STARTED	5	5	5	5
Overall Study COMPLETED	3	3	3	3
Overall Study NOT COMPLETED	2	2	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Once nightly dosing (quaque hora somni \[QHS\])with placebo	QHS (Nightly) Zolpidem Once nightly (QHS) dosing with 10mg of zolpidem	Intermittant Zolpidem Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed	CTRL Monitor only condition.
Overall Study Withdrawn - Medication Expiration	0	2	1	0
Overall Study Withdrawal by Subject	1	0	0	1
Overall Study Failed Screening	1	0	1	1

Baseline Characteristics

Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=5 Participants QHS dosing with placebo	QHS Zolpidem n=5 Participants QHS dosing with 10mg of zolpidem	Intermittant Zolpidem n=5 Participants Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed	CTRL n=5 Participants Monitor only condition.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	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
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants
Age, Categorical >=65 years	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
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Post-treatment (12wks)

Population: Completers Only

Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants QHS (i.e., nightly) dosing with placebo	QHS Zolpidem n=3 Participants QHS (i.e., nightly) dosing with 10mg of zolpidem	Intermittant Zolpidem n=3 Participants Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)	CTRL n=3 Participants Monitor only condition (no placebo and no zolpidem).
Sleep Latency (SL)	1 participants	2 participants	3 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Post-Treatment (12 weeks)

Population: Completers

Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants QHS (i.e., nightly) dosing with placebo	QHS Zolpidem n=3 Participants QHS (i.e., nightly) dosing with 10mg of zolpidem	Intermittant Zolpidem n=3 Participants Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)	CTRL n=3 Participants Monitor only condition (no placebo and no zolpidem).
Wake After Sleep Onset (WASO)	1 participants	2 participants	2 participants	1 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

QHS Zolpidem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intermittant Zolpidem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CTRL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wilfred Pigeon

University of Rochester

Phone: 585 275-3374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place