Daridorexant is an orexin receptor antagonist investigated for both nighttime insomnia symptoms and daytime functioning. Two randomized trials enrolled 930 and 924 adults. Daridorexant 50/25 mg or 25/10 mg, respectively, was compared with placebo each evening for three months.[1.1]
One selected study: A double-blind randomized crossover trial tested daridorexant effects on breathing and sleep in severe sleep apnea. 16 adults with severe obstructive sleep apnea without insomnia, studied at one center. Oral daridorexant 50 mg or placebo each evening for 5 days per treatment period. No clinically meaningful average worsening of apnea frequency or oxygen saturation was detected. Total sleep increased by 32.5 minutes versus placebo (90% CI 6.9-58.2). Reported adverse events were mild. Small, short study in a selected population without insomnia. Average results do not guarantee individual respiratory safety or establish long-term safety; this was not an apnea-treatment trial.[2.1]
Studied methods, not dosing advice. Selected evidence, not a complete literature review or formal quality appraisal. Read the study summary
Source scope is listed with each reference. Prepared by PED Evidence with AI assistance. Independent clinician review has not been completed. Review standards
Evidence summarized on PED Evidence
1 completed summaries
1 human-study reports
1 randomized-trial candidates
0 safety-topic reports
These counts describe completed summaries on this site, not the size of the full literature. Publications can share participants; design labels are discovery metadata, not appraisals.
Two randomized trials enrolled 930 and 924 adults. Daridorexant 50/25 mg or 25/10 mg, respectively, was compared with placebo each evening for three months.
Demonstrated findings
In trial 1, 50 mg reduced overnight wakefulness by 18.3 minutes and time to persistent sleep by 11.7 minutes versus placebo at month three. Daytime sleepiness, a secondary outcome, also improved. The 10 mg group did not meet the reported efficacy tests; 25 mg did not significantly improve daytime sleepiness.
Limitations & adverse findings
Adverse-event rates were broadly similar; headache and nasopharyngitis were common. One death was judged unrelated to treatment. Three-month, sponsor-funded trials do not establish comparative superiority over other sleep medicines.
What might this mean? · interpretation
These results apply to the studied population, formulation and follow-up.
What might this mean, and what would change the interpretation?
This is a selected trial summary, not a full literature review or formal quality appraisal.
What would clarify this: Further studies of long-term outcomes and different patient groups.
Findings reviewed · abstract
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
More about Daridorexant: identity, safety & reference details
Small moleculeSleep & insomnia
Primary research area
Sleep · insomnia
Regulatory status
See formulation-specific sources
Evidence level
Human randomized trials
Primary mechanism
Dual orexin receptor antagonist
Reference profile available · Coverage varies by section
Also known as Quviviq · ACT-541468
What has been observed?
Selected source-linked reading notes, not the complete literature or a pooled conclusion.
Human · Abstract reviewed
Daridorexant: what did the insomnia trial show?
Two randomized trials enrolled 930 and 924 adults. Daridorexant 50/25 mg or 25/10 mg, respectively, was compared with placebo each evening for three months.
In trial 1, 50 mg reduced overnight wakefulness by 18.3 minutes and time to persistent sleep by 11.7 minutes versus placebo at month three. Daytime sleepiness, a secondary outcome, also improved. The 10 mg group did not meet the reported efficacy tests; 25 mg did not significantly improve daytime sleepiness.
Limits & adverse findings: This is a selected trial summary, not a full literature review or formal quality appraisal. Adverse-event rates were broadly similar; headache and nasopharyngitis were common. One death was judged unrelated to treatment. Three-month, sponsor-funded trials do not establish comparative superiority over other sleep medicines.
Two randomized trials enrolled 930 and 924 adults. Daridorexant 50/25 mg or 25/10 mg, respectively, was compared with placebo each evening for three months. [1]
Known half-life
No source-verified value in this profile yet. A treatment schedule or duration of an effect is not a drug half-life.
Half-life describes how quickly the measured drug concentration falls by half. It does not set a dosing interval.
Evidence & important limits
Adverse-event rates were broadly similar; headache and nasopharyngitis were common. One death was judged unrelated to treatment. Three-month, sponsor-funded trials do not establish comparative superiority over other sleep medicines. [1]
Safety & evidence boundaries
Source-specific information, not a personal safety clearance or monitoring plan.
Adverse-event rates were broadly similar; headache and nasopharyngitis were common. One death was judged unrelated to treatment. Three-month, sponsor-funded trials do not establish comparative superiority over other sleep medicines.
Human study: Adverse-event rates were broadly similar; headache and nasopharyngitis were common. One death was judged unrelated to treatment. Three-month, sponsor-funded trials do not establish comparative superiority over other sleep medicines. Source
Explore safety questions by system
These are literature filters, not claims that this compound causes each effect. A keyword match is not a confirmed adverse reaction.
Interactions, rare harms, long-term effects and reversibility require separate evidence. Do not infer they are absent when the sources here do not address them.
Identity, names & formulations
Canonical compound: Daridorexant · daridorexant
Searchable names: Quviviq, ACT-541468
Names share a parent research page. Different esters, salts, routes and brands are not assumed to have the same half-life, indication or exposure.
Combination evidence stays attached to the studied combination. It is not automatically assigned to each ingredient.
Understand the evidence types
Read the model and design first, then the population, outcome and limitations. These categories describe evidence, not a best-compound ranking.
Randomized human trials
Compare assigned interventions. Randomization does not by itself establish low bias or relevance to every population.
Controlled human studies
Use a comparison group; allocation and confounding still matter.
Prospective human research
Follows participants forward. It may be observational or interventional, so this is not a separate quality grade.
Observational human research
Describes associations. Confounding can explain differences.
Case reports and series
Useful for unusual events and safety signals, not reliable rates or effect sizes.
Animal research
Can test biology and function in a living model. Human exposure, benefit and safety remain separate questions.
Cell and tissue research
Tests responses in a preparation, including human-derived cells. It is not a human participant trial.
Mechanistic and computational evidence
Helps explain or predict a pathway; predictions need experimental and clinical testing.
Anecdotal reports
Self-reported experiences can generate questions. Product identity, selection bias and other interventions may be uncontrolled.
Systematic reviews synthesize studies and depend on their quality. Preprint status and abstract versus full-paper reading are separate labels. Citation popularity measures attention, not reliability. A study summary is not a formal quality appraisal.
Reference facts checked 2026-09-23. Source scope is listed above; this is not a formal quality appraisal. See each label for full prescribing information.