Latency to Persistent Sleep (LPS)

Measures the time between the start of the PSG recording and the first 10 consecutive minutes of sleep¹

Wake After Sleep Onset (WASO)

Measures the total amount of time a person is awake between first falling asleep and the end of the PSG recording¹

PSG, polysomnography.

1. Sateia MJ, et al. J Clin Sleep Med. 2017;13:307-349.

Self-Reported Total Sleep Time (sTST)

Total sleep time as estimated by the subject¹

Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score

Novel validated patient-report questionnaire completed daily to assess daytime impairment. Developed per FDA guidance to assess impact of insomnia and treatments²

Total IDSIQ Score

(0-140)

≥17-point reduction from baseline in the Total score indicates a clinically meaningful improvement²

All studies: Exploratory endpoint

Example Question

How mentally tired did you feel today? Scale 0-10 with 0=not at all mentally tired and 10=very mentally tired

1. Sateia MJ, et al. J Clin Sleep Med. 2017;13:307-349.

2. Hudgens S, et al. Patient. 2021;14:249-268.

Safety and tolerability

Treatment-emergent adverse events (TEAEs) that occured during treatment^a

Self-Reported Total Sleep Time (sTST)

Total sleep time as estimated by the subject¹

Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score

Novel validated patient-report questionnaire completed daily to assess daytime impairment. Developed per FDA guidance to assess impact of insomnia and treatments²

Total IDSIQ Score

(0-140)

≥17-point reduction from baseline in the Total score indicates a clinically meaningful improvement²

All studies: Exploratory endpoint

Example Question

How mentally tired did you feel today? Scale 0-10 with 0=not at all mentally tired and 10=very mentally tired

^aAdditional endpoints including Epworth Sleepiness Scale, Visual Analog Scale-assessed morning sleepiness score, Benzodiazepine Withdrawal. Symptom Questionnaire, and rebound insomnia were assessed, but are not included in this infographic. Please refer to the full manuscript.

1. Sateia MJ, et al. J Clin Sleep Med. 2017;13:307-349.

2. Hudgens S, et al. Patient. 2021;14:249-268.

*P = 0.033; **P = 0.0013; ***P < 0.0001 versus placebo.

LSM, least squares mean; sTST, self-reported total sleep time.

***P < 0.0001 versus placebo.

LSM, least squares mean; sTST, self-reported total sleep time.

Adapted from Kunz D, et al. CNS Drugs. 2022;10.1007/s40263-022-00980-8. This article is licensed under a Creative Commons Attribution

NonCommercial 4.0 International License: http://creativecommons.org/licenses/by-nc/4.0/.

**P = 0.0002; ***P < 0.0001 versus placebo.

IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LSM, least squares mean.

1. Hudgens S, et al. Patient. 2021;14:249-268.

*The IDSIQ Sleepiness domain score did not reach statistical significance after controlling for multiple comparisons.

IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LSM, least squares mean.

Adapted from Kunz D, et al. CNS Drugs. 2022;10.1007/s40263-022-00980-8. This article is licensed under a Creative Commons Attribution NonCommercial 4.0 International License: http://creativecommons.org/licenses/by-nc/4.0/.

1.Phillips-Beyer A, et al. Poster presented at SLEEP 2022, the 36th Annual Meeting of the Associated Professional Sleep Societies, LLC (APSS), June 4-8, 2022, Charlotte, NC, USA.