Is daridorexant an effective treatment for short-term (under 3 months) insomnia disorder in adults?
Näytönastekatsaukset
25.6.2026
Level of evidence: B
Daridorexant probably reduces wake after sleep onset (WASO), latency of persistent sleep (LPS), and increases subjective sleep time (sTST) after one month of use with doses 25 mg and 50mg and three months use with 25 mg dose in adult patients with insomnia. At the three month mark, the effects of the 50 mg dose appear to persist.
Quality of evidence was downgraded due to significant unexplained heterogeneity in some of the doses and outcomes. The results did not meet the clinically significant thresholds for NNT
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias [Table « Additional comments for included studies»2Additional comments] |
|---|---|---|---|---|---|
| SR=systematic review | |||||
| «Dutta S, Singhal S, Shah R, et al. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf 2023;22(12):1237-1251 »1 | SR | 4 RCT's with 2768 adult patients, including elderly | daridorexant 10mg, 25mg, or 50mg vs. placebo or zolpidem | 1. Wake After Sleep Onset (WASO) 2. Latency to Persistent Sleep (LPS) 3.Subjective Total Sleep Time (sTST) | Low |
| «Chalet FX, Luyet PP, Rabasa C, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2024;»2 | RCT | 930 patients, post hoc-study | daridorexant 25 mg, 50mg or placebo | 1.NNT (number needed to treat) 2.NNH (number needed to harm) | moderate |
| Reference | Comments |
|---|---|
| «Dutta S, Singhal S, Shah R, et al. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf 2023;22(12):1237-1251 »1 | Studies were well-designed, randomized, and double-blinded. One study had incomplete reporting of outcomes. GRADE and Cochrane tools were used for quality assessment. The 50mg dose in 3 months was evaluated only in 1 RCT with 310 patients in intervention group. |
| «Chalet FX, Luyet PP, Rabasa C, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2024;»2 | The study recruited participants with a latency to persistent sleep (LPS) ≥20minutes, wakefulness after sleep onset (WASO) ≥30minutes, and mean total sleep time (TST) of <7hours, as measured by polysomnography recording during two consecutive nights. Overall, 930 patients were included (all randomized participants; 310 received daridorexant 25mg, 310 received daridorexant 50mg, and 310 received placebo). Mean age was 55.4years and 364 (39%) of the participants were ≥65years old. The majority of patients were female (67% among the treatment arms). |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (SD) I | Mean (SD) C | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision I= intervention; C=comparison; CI=confidence interval | |||||
| «Dutta S, Singhal S, Shah R, et al. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf 2023;22(12):1237-1251 »1 | 25 mg 3 RCT (679/678) | 1 month | -38.9 (4.2) to -18.4 (33.3) | -33.8 (4.2) to -6.2 (33.4) | - 9.1 (-14.56,-3.65) |
| 25 mg 2 RCT (619/618) | 3 months | -24.25 (42.6) to -22.97 (35.7) | -14 (42.4) to -11.1 (36) | -11.19 (-15.51,-6.88) | |
| 50mg 2 RCT (371/370) | 1 month | -48 (4.1) to -28.98 (33) | -33.8 (4.2) to -6.2 (33.4) | -18.11 (-26.48,-9.73) | |
| 50 mg 1 RCT (310/310) | 3 months | -29.4 (-33.4 to -25.4) | -11.1 (-15.1 to -7.1) | -18.3 (-23.9 to -12.7) | |
| «Chalet FX, Luyet PP, Rabasa C, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2024;»2 | |||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (SD) I | Mean (SD) C | Mean Difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision in 50mg dose (I2=60%) I= intervention; C=comparison; CI=confidence interval | |||||
| «Dutta S, Singhal S, Shah R, et al. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf 2023;22(12):1237-1251 »1 | 25mg 3 RCTs (679/678) | 1 month | -37.9 (4.3) to -26.4 (37.2) | -28.4 (4.3) to -19.85 (29.8) | -9.21 (-10.63,-7.79) |
| 25 mg 2 RCTs (619/618) | 3 months | -30.73 (29.6) to -28.9 (40.2) | -23.13 (29.8) to -19.9 (40) | -8.1 (-11.86, -4.34) | |
| 50 mg 2RCTs (371/370) | 1 month | -35.8 (4.3) to -31.2 (29.6) | -28.4 (4.3) to -19.85 (29.8) | -8.73 (-12.39,-5.07) | |
| 50 mg
1 RCT (310/310) | 3 months | -34.8 (-38.1 to -31.5) | -23.1 (-26.5 to -19.8) | -11.7 (-16.3 to -7.0) | |
| «Chalet FX, Luyet PP, Rabasa C, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2024;»2 | |||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean (SD) I | Mean (SD) C | Mean Difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: high I= intervention; C=comparison; CI=confidence interval | |||||
| «Dutta S, Singhal S, Shah R, et al. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf 2023;22(12):1237-1251 »1 | 25mg 3 RCTs (679/678) | 1 month | 34.2 (48.9) to 56.2 (51.5) | 21.6 (48.9) to 52.7 (50.3) | 13.41 (8.13, 18.69) |
| 25 mg 2 RCTs (619/618) | 3 months | 47.8 (58.1) to 56.2 (56.9) | 37.1 (56.6) to 37.9 (58) | 14.55 (5.60, 23.49) | |
| 50 mg 2RCTs (371/370) | 1 month | 43.6 (48.7) to 77.4 (58.7) | 21.6 (48.9) to 52.7 (50.3) | 22.42 (15.27, 29.56) | |
| 50 mg
1 RCT (310/310) | 3 months | 57.7 (51.2 to 64.2) | 37.9 (31.4 to 44.4) | 19.8 (10.6 to 28.9) | |
| «Chalet FX, Luyet PP, Rabasa C, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2024;»2 | |||||
| Reference | Outcome and dose | Follow-up time | Absolute number of events I/All | Absolute number of events C/All | NNT (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval; WASO= wake after sleep onset; LPS= latency to persistent sleep | |||||
| «Chalet FX, Luyet PP, Rabasa C, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2024;»2 | WASO, 25mg | 1 month | 153/298 | 115/299 | 8 (5, 22) |
| WASO, 50mg | 1 month | 182/305 | 115/299 | 5 (4, 8) | |
| WASO, 25 mg | 3 months | 167/289 | 122/283 | 8 (5, 17) | |
| WASO, 50 mg | 3 months | 179/289 | 122/283 | 6 (4, 10) | |
| LPS, 25mg | 1 month | 202/298 | 157/299 | 7 (5, 14) | |
| LPS, 50mg | 1 month | 205/305 | 157/299 | 7 (5,15) | |
| LPS 25mg | 3 months | 200/289 | 175/283 | 15 (-148 to inf to 7) | |
| LPS 50mg | 3 months | 204/287 | 175/283 | 11 (6,74) | |
References
- Dutta S, Singhal S, Shah R, et al. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf 2023;22(12):1237-1251 «PMID: 37526060»PubMed
- Chalet FX, Luyet PP, Rabasa C, et al. Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med 2024;136(4):396-405 «PMID: 38814132»PubMed