Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline.

Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials in which the stimulus could appear in any one of five locations. Lower is better. Minimum score is 100 and maximum score is 5100.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration).

Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials in which the stimulus could appear in any one of five locations. Lower is better. Minimum score is 100 and maximum score is 5100.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration).

Digit Span Maximum Span Passed Forwards is the longest sequence problem successfully reached and passed by the subject. Higher is better. Minimum score is 0 and maximum score is 9.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration).

The Visual Analog Scale for Sedation is a scale where participants indicate their current state on a scale from "Sedated" to "Alert". Higher score is more alert. Minimum score is 0 and maximum score is 12.8.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline.

Digit Span Maximum Span Passed Forwards is the longest sequence problem successfully reached and passed by the subject. Higher is better. Minimum score is 0 and maximum score is 9.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline.

The Visual Analog Scale for Sedation is a scale where participants indicate their current state on a scale from "Sedated" to "Alert". Higher score is more alert. Minimum score is 0 and maximum score is 12.8.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline.

Spatial Working Memory Between Errors is the number of times the subject incorrectly revisits a box in which a token has been previously found. Lower is better. Minimum score is 0 and maximum score is 63.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline.

Paired Associates Learning First Attempt Memory Score is the number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Higher is better. Minimum score is 0 and maximum score is 20.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline.

Rapid Visual Processing Median Response Latency is the median response latency on trials where the subject responded correctly, calculated across all assessed trials. Lower is better. Minimum score is 0 and maximum score is 908.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration).

Spatial Working Memory Between Errors is the number of times the subject incorrectly revisits a box in which a token has been previously found. Lower is better. Minimum score is 0 and maximum score is 63.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration).

Paired Associates Learning First Attempt Memory Score is the number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Higher is better. Minimum score is 0 and maximum score is 20.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration).

Rapid Visual Processing Median Response Latency is the median response latency on trials where the subject responded correctly, calculated across all assessed trials. Lower is better. Minimum score is 0 and maximum score is 908.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Difference between diphenhydramine pharmacokinetic area under the curve (AUC) in elderly subjects aged 65+ vs. adult subjects aged 35 to 50

Blood was collected from study participants as specified in the study protocol; however, samples were destroyed and not analyzed due to early study termination. Therefore, there are no results for this endpoint to report.

Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline.

Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials in which the stimulus could appear in any one of five locations. Lower is better. Minimum score is 100 and maximum score is 5100.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline.

Digit Span Maximum Span Passed Forwards is the longest sequence problem successfully reached and passed by the subject. Higher is better. Minimum score is 0 and maximum score is 9.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline.

The Visual Analog Scale for Sedation is a scale where participants indicate their current state on a scale from "Sedated" to "Alert". Higher score is more alert. Minimum score is 0 and maximum score is 12.8.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline.

Spatial Working Memory Between Errors is the number of times the subject incorrectly revisits a box in which a token has been previously found. Lower is better. Minimum score is 0 and maximum score is 63.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline.

Paired Associates Learning First Attempt Memory Score is the number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Higher is better. Minimum score is 0 and maximum score is 20.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.

Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline.

Rapid Visual Processing Median Response Latency is the median response latency on trials where the subject responded correctly, calculated across all assessed trials. Lower is better. Minimum score is 0 and maximum score is 908.

Data were collected for 3 study participants prior to study termination. There were no participants with data collected at the following time points due to early study termination as no participants were enrolled in the group to have data collected at these time points: 60 min, 240 min, or 480 min post-diphenhydramine. Data were not analyzed via ANOVA with contrast or via PK/PD modeling as planned as there were lack of sufficient data to perform this analysis due to early study termination.