Objective sleep endpoints (WASO, LPS, TST)
Psychiatry· appears in 146+ cited findings in this library
What it is and how the reviews use it
Objective sleep endpoints, including Wake After Sleep Onset (WASO), Latency to Persistent Sleep (LPS), and Total Sleep Time (TST), are measures used in clinical trials to assess various aspects of sleep. These endpoints are utilized to evaluate the efficacy of treatments for sleep disorders.
The regulatory reviews in this library frequently use these objective sleep endpoints to quantify treatment effects. For instance, in the Idorsia Ltd. — Quviviq FDA Review, WASO showed statistically significant treatment effects for the 25-mg and 50-mg doses. The Idorsia Ltd. — Quviviq EMA EPAR public assessment report noted a WASO change from baseline to Month 1 (LS mean difference to placebo) of -12.2. The Vanda Pharmaceuticals Inc. — Hetlioz FDA Review reported a DDTST50 (total sleep time) mean difference versus placebo of 18.5 minutes. Furthermore, the Axsome Therapeutics, Inc. — Sunosi FDA Review specified a minimum usual nightly total sleep time for inclusion of 6 hours, while the RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation assessment report indicated a total sleep time at baseline of 7.5+/-0.3 hours.
Real examples — cited to the source page
| Axsome Therapeutics, Inc. — Sunosi | Minimum usual nightly total sleep time for inclusion | 6 | Sunosi FDA Review, p.68 |
| RAD Neurim Pharmaceuticals — Slenyto | Total sleep time at baseline | 7.5+/-0.3 | Slenyto EMA EPAR variation assessment rep, p.14 |
| Idorsia Ltd — Quviviq | WASO statistically significant treatment effects | 25-mg and 50-mg doses in Trials ID-078A301 and for the 25-mg dose in ID-078A302 | Quviviq FDA Review, p.29 |
| Idorsia Ltd — Quviviq | WASO change from baseline to M1 (LS mean difference to placebo) | -12.2 | Quviviq EMA EPAR public assessment report, p.92 |
| Vanda Pharmaceuticals Inc. — Hetlioz | DDTST50 (total sleep time) mean difference vs placebo | 18.5 | Hetlioz FDA Review, p.18 |
| Eisai Co., Ltd. — Dayvigo | Minimum subjective wake after sleep onset (sWASO) for inclusion | 60 | Dayvigo FDA Review, p.128 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
Explore the full evidence
Every Objective finding in the library — searchable and answerable in plain language — is in the Psychiatry research library →
Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.