| Indication | Insomnia |
| Drug | Daridorexant |
| Mechanism of Action | Dual orexin receptor antagonist |
| Company | Idorsia Pharmaceuticals Ltd |
| Category | Corporate & Strategic |
| Sub Category | Licensing Agreement |
| Therapeutic Area | Neuroscience |
| Partner Company | Jamjoom Pharmaceuticals Factory Co. |
| Licensed Territory | Saudi Arabia, Levant region |
| Deal Structure | Exclusive agreement |
| Financial Terms | Upfront payment, royalties on net sales |
| Marketing Authorization Holder | Jamjoom Pharma |
| Clinical Trial Journal | The Lancet Neurology |
| Dosage Strengths Tested | 25mg, 50mg |
Idorsia Partners with Jamjoom Pharma for QUVIVIQ Rollout
Idorsia Ltd has entered into an exclusive agreement with Jamjoom Pharmaceuticals Factory Co. for the distribution and commercialization of QUVIVIQ (daridorexant), Idorsia’s treatment for adults with insomnia, in Saudi Arabia and the Levant region. This partnership is a key step in Idorsia's international growth strategy, leveraging Jamjoom Pharma's strong market presence and regulatory expertise to expand patient access. Under the terms, Idorsia will receive an upfront payment and royalties on net sales, while Jamjoom Pharma will be responsible for marketing authorization, regulatory, distribution, promotion, and commercialization activities in the agreed territories.
- Idorsia has forged an exclusive agreement with Jamjoom Pharma for the distribution and commercialization of QUVIVIQ (daridorexant) in Saudi Arabia and the Levant region. This strategic partnership is instrumental in executing Idorsia's international growth strategy, aiming to maximize patient access to its innovative insomnia treatment by leveraging Jamjoom Pharma's robust market presence, deep regulatory expertise, and established commercial infrastructure.
- The financial and operational terms of the agreement stipulate that Idorsia will receive an upfront payment and is eligible for additional payments, including royalties on net sales from QUVIVIQ. Jamjoom Pharma will assume responsibility for obtaining marketing authorization for QUVIVIQ in Saudi Arabia, as well as managing all regulatory, distribution, promotion, and commercialization activities across Saudi Arabia and the Levant region, with Idorsia supplying the finished drug product.
- QUVIVIQ (daridorexant) is highlighted as a distinct insomnia treatment, functioning as a dual orexin receptor antagonist that selectively targets the orexin system to regulate overactive wake signaling. Clinical trials, published in The Lancet Neurology, demonstrated that daridorexant significantly improved sleep onset, sleep maintenance, and self-reported total sleep time at 25mg and 50mg doses, with the 50mg dose also showing significant improvement in daytime functioning compared to placebo.
The Persistent Unmet Needs Driving QUVIVIQ's Global Expansion
Insomnia care continues to reveal significant gaps across diverse patient populations, with unmet needs spanning accessibility, safety, and treatment personalization. Despite CBT-I's status as the gold-standard first-line treatment, structural and demographic barriers persist, driving demand for novel pharmacological and digital solutions like dual orexin receptor antagonists (DORAs).
Older adults (≥50-65 years) remain the largest underserved population, with sleep difficulties affecting 20-40% of this group and driving chronic, often off-label pharmacotherapy that deviates from clinical guidelines. Polypharmacy further complicates management, increasing risks of drug interactions, falls, and cognitive decline, while long-term benzodiazepine receptor agonist (BZRA) use—flagged as low-value care—remains inadequately deprescribed in routine practice.
Cognitively vulnerable populations, including persons with dementia (ADRD) and mild cognitive impairment (MCI), face compounding challenges: sleep disturbances accelerate cognitive decline and institutionalization, yet neurocognitive limitations hinder engagement with CBT-I, and tailored non-pharmacologic alternatives (e.g., music interventions, rTMS combined with CBT-I) remain underdeveloped or insufficiently tested.
Women—particularly female cancer survivors—represent a growing, underserved segment, with insomnia prevalence reaching 62% in breast cancer survivors (three times the general population rate). Iatrogenic menopause from oncological treatments, hormonal regulation of sleep-wake pathways, and greater cognitive-emotional arousal contribute to elevated risk, compounded by systemic gender bias where women are overprescribed sedatives while men remain underdiagnosed.
Racial and socioeconomic disparities restrict equitable access to care, with non-White populations reporting lower awareness of insomnia treatments and shift work/job insecurity further limiting diagnosis and treatment uptake—often resulting in medication overuse in place of behavioral interventions.
Public awareness gaps favor pharmacological over behavioral treatments: a nationally representative U.S. survey (n=3,080) found substantially higher familiarity with medications than CBT-I, a pattern reinforced by media and pharmaceutical industry promotion, alongside a persistent shortage of trained CBT-I providers and limited eHealth/digital CBT-I availability in many countries.
Emerging innovations aim to close these gaps, including tiered digital CBT-I platforms, AI-driven personalization, tryptophan-rich nutritional interventions for cancer patients, and DORAs (daridorexant, lemborexant, suvorexant)—which demonstrate favorable efficacy on WASO, sleep latency, and total sleep time, with daridorexant showing a particularly favorable safety profile and no significant fall-risk signal across the class.
QUVIVIQ: A Differentiated Approach to Insomnia Treatment Challenges
Current pharmacological and non-pharmacological approaches to insomnia face significant hurdles that challenge effective patient management. Despite a range of available therapies, their utility is often constrained by concerns regarding safety and tolerability, inconsistent efficacy, limited accessibility, and notable gaps in the supporting clinical evidence, particularly for special populations.
Adverse Effects and Safety Concerns: Many established pharmacological agents, including benzodiazepines and non-benzodiazepine hypnotics (Z-drugs), carry risks of dependence, withdrawal symptoms, and rebound insomnia. There is growing concern over both short- and long-term adverse effects, such as residual next-day sedation, cognitive impairment, and complex sleep behaviors, which are particularly problematic in patients over 65 years old.
Limited Evidence and Efficacy Gaps: The evidence base supporting the efficacy of many commonly used treatments is limited. This includes frequently prescribed off-label agents like antidepressants and antipsychotics, as well as complementary medicines such as melatonin, which suffers from inconsistent product quality and a need for more robust clinical trials. Even newer agents like the dual orexin receptor antagonist suvorexant lack direct head-to-head comparative data against other approved hypnotics.
Challenges in Special Populations: Treating pediatric insomnia is difficult, as the condition is often underdiagnosed and undertreated in primary care. Pharmacotherapy is frequently employed off-label, with treatment decisions based on data extrapolated from adult studies due to a scarcity of dedicated research in children and adolescents.
Restricted Access to First-Line Non-Pharmacological Therapy: Although cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line intervention by multiple specialty societies, its practical application is severely restricted. A widespread lack of trained behavioral providers limits patient access to in-person CBT-I, and while digital versions (dCBT-I) are emerging, they currently lack sufficient randomized controlled trial data in pediatric populations.
Positioning Daridorexant in the Orexin Receptor Antagonist Landscape
Daridorexant joins two other approved dual orexin receptor antagonists (DORAs), lemborexant and suvorexant, in the market for insomnia. This class of drugs inhibits wakefulness by blocking the orexin neuropeptide signaling system, a distinct mechanism from traditional sedative-hypnotics. Several other DORAs have also been evaluated in clinical trials, though some have since been discontinued.
| Drug Name | Development Status | Key Trial Information / Intervention Model |
|---|---|---|
| Lemborexant | FDA Approved | Two Phase 3 studies were conducted from 2016-2019. A 2025 pragmatic, three-arm RCT will compare lemborexant to Cognitive Behavioral Therapy for Insomnia (CBT-I) and placebo in adults with chronic insomnia and comorbid anxiety/depressive symptoms. |
| Suvorexant | FDA Approved (First-in-class) | Phase 3 trials were completed prior to its 2014 approval. Subsequent trials have focused on comorbid insomnia, including a 4-week RCT in women with nighttime vasomotor symptoms and an RCT in post-cardiac surgery ICU patients. An abuse potential study compared single doses of suvorexant to zolpidem and placebo in recreational polydrug users. |
| Filorexant (MK-6096) | Reached Phase II | While it has shown a sleep-promoting effect, few recent clinical or experimental studies have been published. |
| Vornorexant | Submitted for Approval | An application for regulatory approval has been submitted. |
| ACT-462206 | Preclinical / Potential Candidate | Identified as a potent and selective DORA and a potential candidate for insomnia treatment. |
| Almorexant | Development Discontinued | Showed significant improvements in sleep parameters in animal models and patients, but its development was halted. |
| SB-649868 | Development Discontinued | Demonstrated efficacy and tolerability in Phase II trials before development was stopped. |
Frequently Asked Questions
References
- [1] Uslaner JM, Herring WJ et al.. The Discovery of Suvorexant: Lessons Learned That Can Be Applied to Other CNS Drug Development Efforts. ACS pharmacology & translational science. 2020 Feb 14. 32259095
- [2] Chaki S. Orexin receptors: possible therapeutic targets for psychiatric disorders. Psychopharmacology. 2025 Aug. 40153060
- [3] Schilling U, Henrich A et al.. Impact of Daridorexant, a Dual Orexin Receptor Antagonist, on Cardiac Repolarization Following Bedtime Dosing: Results from a Thorough QT Study Using Concentration-QT Analysis. Clinical drug investigation. 2021 Aug. 34331678
- [4] Schoedel KA, Sun H et al.. Assessment of the Abuse Potential of the Orexin Receptor Antagonist, Suvorexant, Compared With Zolpidem in a Randomized Crossover Study. Journal of clinical psychopharmacology. 2016 Aug. 27253658
- [5] Boss C, Roch-Brisbare C et al.. Structure-activity relationship, biological, and pharmacological characterization of the proline sulfonamide ACT-462206: a potent, brain-penetrant dual orexin 1/orexin 2 receptor antagonist. ChemMedChem. 2014 Nov. 25147058
- [6] Markham A. Daridorexant: First Approval. Drugs. 2022 Apr. 35298826
- [7] Martella S, Proserpio P et al.. Insomnia in Women Surviving Breast and Gynecological Cancers-A Narrative Review to Address the Hormonal Factor. Cancers. 2025 Dec 17. 41463270
- [8] Weiss SK, Garbutt A. Pharmacotherapy in pediatric sleep disorders. Adolescent medicine: state of the art reviews. 2010 Dec. 21302858
- [9] Rollo E, Antonioni A et al.. Pitfalls of insomnia management in the elderly: A narrative review. Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2026 Jan 2. 41483206
- [10] Gilron I, Dickenson AH. Emerging drugs for neuropathic pain. Expert opinion on emerging drugs. 2014 Sep. 24793304
- [11] Becker PM, Somiah M. Non-Benzodiazepine Receptor Agonists for Insomnia. Sleep medicine clinics. 2015 Mar. 26055674
- [12] Diamond AB, Fried PJ et al.. Treating insomnia in mild cognitive impairment: a novel approach combining transcranial magnetic stimulation with cognitive behavioral therapy. International review of psychiatry (Abingdon, England). 2026 May 19. 42157607
- [13] Ariza-Salamanca DF, Venegas M et al.. Expert Consensus on the Use of Diphenhydramine for Short-Term Insomnia: Efficacy, Safety, and Clinical Applications. Journal of clinical medicine. 2025 May 9. 40429293
- [14] Pallanti S. The role of benzodiazepines in common conditions: a narrative review focusing on lormetazepam. International clinical psychopharmacology. 2024 May 1. 38277240
- [15] Aakre JA, Bjorvatn B et al.. Preventing and Treating Insomnia Symptoms in Midlife and Older Adults (ASLEEP): Protocol for a Randomized Controlled Trial Using the PROTECT Norge Infrastructure. JMIR research protocols. 2026 Mar 2. 41773671
- [16] Miner B, Chen A et al.. Performance of an electroencephalography-measuring headband or actigraphy compared with polysomnography in older adults with sleep disturbances. Sleep. 2026 May 12. 41757511
- [17] MacFarlane J, Morin CM et al.. Hypnotics in insomnia: the experience of zolpidem. Clinical therapeutics. 2014 Nov 1. 25455931
- [18] Ruedisueli I, Marienfeld C et al.. "Chill packs" self-administered olanzapine as psychiatric harm reduction for methamphetamine-induced psychosis: a narrative review of the existing evidence base. Harm reduction journal. 2026 Jun 4. 42243786
- [19] Andrews SP, Aves SJ et al.. Orexin Receptor Antagonists: Historical Perspectives and Future Opportunities. Current topics in medicinal chemistry. 2016. 26416477
- [20] Sarathi Chakraborty D, Choudhury S et al.. Daridorexant, a Recently Approved Dual Orexin Receptor Antagonists (DORA) in Treatment of Insomnia. Sleep science (Sao Paulo, Brazil). 2023 Jun. 37425970
Contact Us
Address
One Research Ct, Suite 450
Rockville, MD 20850
For General Inquiry
info@pienomial.com











