Is daridorexant an effective treatment for long-term (>3 months) insomnia in adults patients?
Näytönastekatsaukset
2.6.2026
Level of evidence: C
Daridorexant may increase subjective sleep time (sTST) by 5.3 to 20.3 minutes and decrease Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ) points by 4.5 to 9 points in long-term use up to 52 weeks in adults with insomnia.
Quality of evidence was downgraded due to results based on two RCTs, one having significant limitations in data presentation and gathering.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias [Table «Additional comments for included studies»2 Additional comments] |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review | |||||
| «Kunz D, Dauvilliers Y, Benes H, et al. Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs 2023;37(1):93-106 »1 | RCT | 1684 adult patients (aged ≥ 18 years) with diagnosed insomnia disorder between October 2018 and February 2021 at 94 sites in 14 countries that had completed previous 12 week trial (extension trial) | daridorexant 10mg, 25mg, or 50mg vs. ex-placebo/daridorexant 25mg vs placebo | 1.Change in subjective total sleep time (sTST) 2.Change in IDSIQ score | Low |
| «Uchimura N, Ozone M, Suzuki M, et al. Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder. Sleep Med 2024;122():64-70 »2 | RCT | Multicenter, randomized, open-label Phase 3 study in 154 adult Japanese patients with insomnia disorder in 72 sites across Japan from November 17, 2020 to September 7, 2022. | daridorexant 25 mg, or 50mg | 1.Change in subjective total sleep time 2. Change in IDSIQ score | moderate |
| Reference | Comments |
|---|---|
| «Kunz D, Dauvilliers Y, Benes H, et al. Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs 2023;37(1):93-106 »1 | The extension study consisted of a 40-week treatment period followed by a 30-day safety follow-up period. Patients originally randomised to 12 weeks of placebo were re-randomised (1:1) to receive double-blind daridorexant 25 mg (‘ex-placebo/daridorexant 25 mg') or placebo for 40 weeks. Insomnia Severity Index score ≥ 15 and a self-reported history of disturbed sleep (≥ 30 min to fall asleep, ≥ 30 min awake during sleep time, self-reported total sleep time [sTST] ≤ 6.5 h) for ≥ 3 nights per week for ≥ 3 months. The following PSG criteria were required to be met: latency to persistent sleep ≥ 20 min, wake after sleep onset ≥ 30 min and mean total sleep time < 7 h. Mean age was 58 years (range 19–85 years), with 41.7% aged ≥ 65 years. The majority of patients were female (71.5%) and White (89.8%). At the start of the extension study, comorbidities and concomitant therapies were reported in 72.1% and 64.8% of patients, respectively |
| «Uchimura N, Ozone M, Suzuki M, et al. Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder. Sleep Med 2024;122():64-70 »2 | After screening period (7–28 days) patients were randomized (2:1) to receive orally, one tablet of daridorexant 50 mg or 25, for 52 weeks, followed by a 30-day safety follow-up period. Participants had a self-reported history of disturbed sleep on ≥3 nights per week for ≥3 months before screening, i.e., all the following: subjective latency to sleep onset (sLSO) ≥30 min, subjective wake after sleep onset (sWASO) ≥30 min and subjective total sleep time (sTST) ≤6.5 h. These subjective sleep parameters were also required to be met on ≥3 nights in the week prior to the start of treatment. No formal sample size calculation was performed; the study was planned to enroll 150 subjects to ensure the inclusion of 100 subjects to complete 52 weeks of treatment. The overall mean age was 54.4 years (range 19–89 years) with 31 % aged ≥65 years and 55 % female |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Least square mean (95% CI) or Mean (SD) I | Least square mean (95% CI) or Mean (SD) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due imprecision and indirectness (subjective questionnaires, no PSG) I= intervention; C=comparison; CI=confidence interval; sTST=subjective total sleep time; *=statistically significant effect | |||||
| «Kunz D, Dauvilliers Y, Benes H, et al. Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs 2023;37(1):93-106 »1 | 10 mg (142/128) | 36 weeks | 67.9 (55.66, 80.04 | 57.4 (44.17, 70.62 | 10.5 (-7.51, 28.42) |
| 25 mg (270/128) | 36 weeks | 62.7 (53.85, 71.46) | 57.4 (44.17, 70.62 | 5.3 (-10.59, 21.11) | |
| 50 mg (137/128) | 36 weeks | 75.2 (62.72, 87.61) | 57.4 (44.17, 70.62 | 17.8 (-0.35, 35.90) | |
| «Uchimura N, Ozone M, Suzuki M, et al. Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder. Sleep Med 2024;122():64-70 »2 | 25 mg (52) | 52 weeks | 80.5 min (54.4) | N/A | 9.2 (0.3, 18.1)* |
| 50 mg (102) | 52 weeks | 93.6 min (SD 57.5) | N/A | 20.3 (11.4, 29.2)* | |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Least square mean (95% CI) I | Least square mean (95% CI) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision I=intervention; C=comparison; CI=confidence interval; IDSIQ, Insomnia Daytime Symptoms and Impact Questionnaire, *=statistically significant effect | |||||
| «Kunz D, Dauvilliers Y, Benes H, et al. Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs 2023;37(1):93-106 »1 | 10 mg (142/128) | 36 weeks | -23.4 (-27.72, -19.11) | -17.4 (-22.14, -12.71 | -6.0 (-12.37, 0.39) |
| 25 mg (270/128) | 36 weeks | -21.9 (-25.06, -18.83) | -17.4 (-22.14, -12.71 | -4.5 (-10.15, 1.12) | |
| 50 mg (137/128) | 36 weeks | -26.6 (-30.99, -22.11) | -17.4 (-22.14, -12.71 | -9.1 (-15.59, -2.66)* | |
| «Uchimura N, Ozone M, Suzuki M, et al. Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder. Sleep Med 2024;122():64-70 »2 | 25 mg (52) | 52 weeks | -28.5 (SD 26.7) | N/A | N/A |
| 50 mg (102) | 52 weeks | -25.4 (SD 23.5) | N/A | N/A | |
References
- Kunz D, Dauvilliers Y, Benes H, et al. Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs 2023;37(1):93-106 «PMID: 36484969»PubMed
- Uchimura N, Ozone M, Suzuki M, et al. Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder. Sleep Med 2024;122():64-70 «PMID: 39128336»PubMed