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Last update 13 Sep 2025

Zolpidem Tartrate

Last update 13 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryZolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit ontaining GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation. Zolpidem is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Drug Type

Small molecule drug

Synonyms

N,N,6-Trimethyl-2-(4-methylphenyl)imidazo(1,2-a)pyridine-3-acetamide, Zolpidem tartrate (JP17/USP), Zolpidem Tartrate Granules

+ [29]

Target

GABAA receptor

Action

agonists

Mechanism

GABAA receptor agonists(Gamma-aminobutyric acid A receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Sleep Initiation and Maintenance Disorders

Inactive Indication

Attention Deficit Disorder With HyperactivityBipolar DisorderChronobiology Disorders+ [3]

Originator Organization

Sanofi

Active Organization

ALMATICA PHARMA INC

Astellas Pharma, Inc.

Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

+ [3]

Inactive Organization

Biovail Laboratories International SRL

SanofiTranscept Pharmaceuticals, Inc. (Old)

+ [2]

License Organization

Purdue Pharmaceutical Products, Inc.

Paratek Pharmaceuticals, Inc.

Sanofi-Aventis U.S. LLC

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (16 Dec 1992),

Sleep Initiation and Maintenance Disorders

Regulation-

Structure/Sequence

Molecular FormulaC23H27N3O7

InChIKeyNYVVVBWEVRSKIU-LREBCSMRSA-N

CAS Registry99294-93-6

165

Clinical Trials associated with Zolpidem Tartrate

CTRI/2024/07/071200

/ Not yet recruitingPhase 4

A Prospective, Multicenter, Open labeled, Randomized, phase IV clinical study to evaluate safety and efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg / 10 mg plus Melatonin 3 mg film coated tablets in subjects with Primary Insomnia and Sleep Disorder. - NIL

Start Date03 Aug 2024

Sponsor / Collaborator-

NCT06512155

/ CompletedPhase 1IIT

The Effect of Pregabalin on Perioperative Sleep Quality in Orthopedic Surgery Patients: a Prospective, Randomized, Controlled Study

In today's day of increasing surgical volume, perioperative sleep disorders are an issue that cannot be ignored. They are an important component of perioperative brain protection. Physiologically and psychologically, sleep disorders cause serious damage to patients. The application of pregabalin aims to improve the sleep quality of hand surgery patients, and its anti anxiety effect can also alleviate preoperative anxiety. At the same time, its analgesic mechanism is different from that of opioid drugs, which is also conducive to reducing the use of opioid drugs. Therefore, we propose the following hypothesis: for orthopedic patients with high incidence of postoperative pain and sleep disorders, the use of pregabalin will improve the perioperative sleep quality of such patients.To test the above hypothesis, our research group plans to conduct this prospective, randomized, positive control study.

Start Date02 Jul 2024

Sponsor / Collaborator

Sichuan Provincial People's Hospital

CTRI/2024/06/069379

/ Not yet recruitingPhase 2

Efficacy of Dalk i Layyin (soft massage) and Saut (nasal drops) with Roghan i kaddu in Sahr (Primary Insomnia) A randomised controlled clinical trial - nil

Start Date01 Jul 2024

Sponsor / Collaborator

National Institute of Unani Medicine

100 Clinical Results associated with Zolpidem Tartrate

100 Translational Medicine associated with Zolpidem Tartrate

100 Patents (Medical) associated with Zolpidem Tartrate

4,946

Literatures (Medical) associated with Zolpidem Tartrate

01 Dec 2025·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Development and validation of a LC–MS/MS method for the detection of 38 benzodiazepines and 2 Z-drugs in blood

Article

Author: Liu, Xin-Ze ; Liu, Yu ; Guo, Zhen-Shuo ; Yan, Hui ; Xiang, Ping

Benzodiazepines and Z-drugs are commonly used as prescription medications to treat anxiety, epilepsy, insomnia, and alcohol withdrawal syndrome, but their use can lead to tolerance, dependence, and withdrawal reactions if taken against official guidelines. Furthermore, designer benzodiazepines, most of which lack clinical and toxicological data, have entered the illicit drug market as new psychoactive substances and are used for recreational purposes. Their abuse can cause confusion, memory loss, respiratory depression, and even death, especially when combined with other sedative-hypnotics or alcohol. Therefore, new qualitative and quantitative methods for benzodiazepines and Z-drugs are needed for use in forensic and clinical toxicology. This study explored the sample preparation and liquid-liquid extraction using 0.5 mL blood samples and 2 mL of extraction solvent for analysis of these drugs by liquid chromatography-tandem mass spectrometry and multiple reaction monitoring. The benzodiazepines were separated on a pentafluorophenylpropyl (PFPP) column using a mobile phase gradient consisting of A (water, 0.1 % formic acid, 5 % acetonitrile, and 20 mmol/L ammonium acetate) and B (acetonitrile) for 9 min. Validation steps confirmed that the method demonstrated good selectivity, sensitivity (limit of detection: 0.2 ng/mL, lower limit of quantification: 0.5 ng/mL), linearity (R² ≥ 0.99), accuracy, and precision (<20 %). Matrix effects ranged from 35 to 126 %, and recoveries ranged from 17 to 99 %, with 35 compounds having recoveries of more than 50 %. The method was successfully applied for the identification and quantification of benzodiazepines and nonbenzodiazepines in blood samples from 15 authentic poisoning cases. Ten analytes were detected: alprazolam (130.2-575.3 ng/mL), hydroxyalprazolam (2.3-37.3 ng/mL), clonazepam (11.7-773.2 ng/mL), lorazepam (63.4-166.9 ng/mL), 7-aminoclonazepam (17.4-385.3 ng/mL), oxazepam (2.6-964.1 ng/mL), diazepam (227.2 ng/mL), nordazepam(22.4 ng/mL), zolpidem (11.8-64.0 ng/mL), midazolam (70.2 ng/mL), and hydroxymidazolam (162.8 ng/mL).

01 Oct 2025·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Intranasal empagliflozin modulates synaptic plasticity in migraine: Insights into calcium signaling and epigenetic regulation

Article

Author: El-Ganainy, Samar O ; El-Mezayen, Nesrine S ; Noah, Ashraf A

Migraine is a primary headache disorder without a definite pathophysiology or satisfactory managing strategies. Recently, migraine is primarily a disorder of brain plasticity coupled with altered Ca²⁺ dynamics regulating gene activity and protein expression. Further, epigenetics provided new insight into migraine pathogenesis and therapeutic response elucidation. Sodium-glucose co-transporter-2-inhibitors (e.g., empagliflozin (EMPA)), are a class of antihyperglycemic agents that can cross the blood-brain-barrier to maintain glucose homeostasis. EMPA possesses myriad pharmacological actions with potential beneficial effects for migraine management. Thus, the current study aimed at exploring EMPA efficacy and mechanisms for treating migraine headache, emphasizing its role in synaptic plasticity and epigenetic mechanisms. Using an animal model of chronic migraine headache, the effect of oral (PO)/intranasal (IN) (brain-targeted)-EMPA versus Zolmitriptan (ZOL) on serum pain marker; Substance-P and migraine symptoms; pain, and photophobia were assessed biochemically and behaviorally. The influence on synaptic plasticity was evaluated by quantifying immunohistochemically stained synaptophysin in brain tissues and assessing calcium/calmodulin-activated-kinases (CaMKIIa)/ Camp-response-element-binding-protein (CREB)/calcitonin-gene-related-peptide (CGRP) or brain-derived-neurotrophic-factor (BDNF) pathways. Further, epigenetic modulation of migraine key genes was evaluated by determining HDAC6, CALCR, and MiR155-5p Moreover, serum glucose and amylin levels were appraised. Both EMPA-PO/IN significantly decreased serum levels of substance-P and pain symptoms, increased brain serotonin levels, synaptophysin expression, and modulated the CaMKIIa/CREB/CGRP/or BDNF pathway. In addition, EMPA-IN, but not ZOL, down-regulated HDAC6, CALCR, and MiR155-5p expressions. Further, unlike EMPA-IN, ZOL, and EMPA-PO demonstrated significant hypoglycemic effects. In conclusion, EMPA-IN shows potential as a novel therapeutic approach for managing migraine headaches by enhancing synaptic plasticity and modulating altered migraine-related epigenetic mechanisms.

25 Sep 2025·Psychiatry Investigation

The Association of Zolpidem and Suicidality in Psychiatric Outpatients With Insomnia

Article

Author: Lyoo, In Kyoon ; Kim, Seog Ju ; Kim, Yunsu ; Kim, Haein ; Yeo, Hyewon ; Jung, Jin Young ; Yoon, Sujung

Objective Zolpidem is widely prescribed to psychiatric outpatients for the management of insomnia due to its rapid and potent efficacy. However, concerns persist regarding its potential association with suicidal tendencies. While studies have suggested that Z-drugs may influence suicidal behavior in the general population, the specific association of Z-drug use and suicide risk in psychiatric outpatients with insomnia remains unclear. This study aims to investigate the association of zolpidem use and suicidal tendencies in this population.Methods This retrospective study analyzed the medical records of psychiatric outpatients who visited a mental health clinic between January 2018 and December 2022. Of the 6,193 patients assessed, 3,128 (average age: 49.4 years; 36.6% male) reported insomnia, and 364 (11.6%) were prescribed zolpidem. Suicidal tendencies including past suicide attempts, current suicidal ideation, and plans were evaluated in relation to zolpidem use.Results Psychiatric outpatients with insomnia who used zolpidem demonstrated significantly higher rates of suicidal tendencies (χ²=3.97, p=0.046) and suicide attempts (χ²=8.12, p=0.004, 23.6% in zolpidem users) compared to non-users. Logistic regression analysis revealed that zolpidem use was significantly associated with increased suicidal tendencies (β=0.314, standard error=0.137, odds ratio= 1.368, 95% confidence interval [CI] 1.05–1.79, p=0.022), suicidal ideation (β=0.326, standard error=0.138, odds ratio=1.386, 95% CI 1.06–1.82, p=0.018), and suicide attempts (β=0.379, standard error=0.157, odds ratio=1.460, 95% CI 1.07–1.98, p=0.016), even after adjusting for relevant clinical factors.Conclusion This study highlights a significant association of zolpidem use and elevated suicidal tendencies among psychiatric outpatients with insomnia. Although a causal relationship cannot be definitively established, these findings highlight the critical importance of thorough suicide risk assessment and ongoing monitoring in patients prescribed zolpidem.

News (Medical) associated with Zolpidem Tartrate

01 Sep 2025

·www.idorsia.com

Idorsia furthers the science of sleep and insomnia at World Sleep 2025

Allschwil, Switzerland – September 1, 2025Idorsia Ltd (SIX: IDIA) continues its commitment to furthering the science of sleep and insomnia with a symposium and eight poster presentations at World Sleep 2025, a global scientific congress bringing the best of sleep medicine and research, in Singapore from September 5-10, 2025. Idorsia’s scientific poster presentations at World Sleep 2025: Real-world data assessment of abuse potential of insomnia therapiesA study to examine the real-world abuse potential of approved and off-label medications used for the treatment of insomnia, using data from the FDA Adverse Event Reporting System (FAERS) database. Real-world data on the abuse potential of medications for the treatment of insomnia. P. Saskin, W.V. McCall, D. Neubauer, A. Crucitti, P.P. Luyet, R. Jaziri, C. Vaillant. Abstract available online Efficacy of daridorexant throughout the night Effect of daridorexant on wakefulness throughout the night: Post-hoc analysis of a randomised, double-blind, active reference (zolpidem) study in patients with insomnia disorder. B. Steiniger-Brach, O. Briasoulis, A. Olivieri, S. Pain, L. Palagini, D. Kunz, P.-A. Geoffroy. Abstract available online Effect of daridorexant on wakefulness throughout the night and morning sleepiness in patients with insomnia disorder. Y. Dauvilliers, G. Zammit, P.-P. Luyet, G. Braunstein, O. Briasoulis, A. Olivieri. Abstract available online Impact of daridorexant in patients with insomnia and additional health conditions Efficacy and safety of daridorexant in women with insomnia disorder during menopausal transition: a subgroup analysis. O. Briasoulis, Z. Schaedel, C. Bassetti, S.M. Bertisch, P. Cassel, S. Palacios, C. Palmay, R. Silvestri, P. Stute, F. Trémollieres, T. Bakker, S. Pain. Abstract available online Efficacy and safety of daridorexant in patients with chronic insomnia disorder and comorbid nocturia. K. Lederer, S. Schoffner, J.-E. Batista Miranda, R. Rowles, A. Olivieri, M. Meinel. Abstract available online Characterization of patients with insomnia disorderThe largest clinical characterization of patients with insomnia disorder to date. Drawing on data from more than 5000 patients screened in the Phase 3 daridorexant program, these analyses provide important insights into the significant and wide-ranging impact of insomnia disorder on objective and subjective nighttime symptoms and daytime functioning. Subgroup analyses by sex and age provide important insights on how insomnia disorder may affect different patient populations. The impact of insomnia disorder on the night and the day: analysis of polysomnography and subjective parameters from a large clinical trial database. M. Fernandes, A. Olivieri, O. Briasoulis, J. Laurent, C. Liguori. Abstract available online The impact of insomnia disorder on the night and the day in older and younger adults. M. Fernandes, A. Olivieri, O. Briasoulis, J. Laurent, C. Liguori. Abstract available online The impact of insomnia disorder on the night and the day in males and females. M. Fernandes, A. Olivieri, O. Briasoulis, J. Laurent, C. Liguori. Abstract available online Educational symposiumOn Tuesday, September 9, from 12:45 to14:15, Idorsia will host an educational symposium featuring experts David Neubauer (US), Lu Lin (China), Atul Khullar (Canada), Laura Palagini (Italy), and Claudio Liguori (Italy). The symposium will explore the link between insomnia and neurological or psychiatric comorbidities, focusing on the role of orexin. New clinical and real-world data on daridorexant will be presented, alongside practical strategies for managing insomnia in patients with comorbidities through case discussions. The event will conclude with a Q&A and panel discussion to foster expert–attendee dialogue. About World Sleep 2025World Sleep 2025 will be the 18th World Sleep Congress. This congress facilitates an international discussion forum and collaboration among sleep societies and sleep professionals. Sleep clinicians, technologists, trainees, educators, and scientists from around the world will meet to advance knowledge on sleep science, sleep in public health, sleep health, and sleep-wake disorders, their diagnosis and treatments. World Sleep Society seeks to maximize learning both from formal presentations by the leading experts in their fields and from informal discussion groups emphasizing opportunities for networking and member participation. Notes to the editor About IdorsiaThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

Phase 3

04 Jul 2025

·pharma.economictimes.indiatimes.com

NCB busts global drug cartel using encrypted apps, crypto and B2B platforms

New Delhi: In one of the largest crackdowns on the illegal pharmaceutical trade , the Narcotics Control Bureau (NCB) has dismantled an international drug trafficking syndicate operating across four continents, using encrypted digital platforms, cryptocurrency, and anonymous shipping networks, an official statement said. The breakthrough began with the interception of a vehicle near Bengali Market in Delhi on May 25, 2025, ultimately uncovering a vast transnational operation with links to India, the US, Australia, and Europe. The investigation was launched after the NCB HQ Operations Unit intercepted a car near Mandi House, Delhi, based on a tip-off. The vehicle's two occupants, B. Pharma graduates from a reputed Noida-based private university, were found in possession of 3.7 kg of Tramadol tablets--a controlled medication often misused as a narcotic. Their confession exposed a deeper network that involved an online vendor profile on a major Indian B2B platform, used to ship pharmaceutical pills to clients in the United States, Europe, and Australia. Subsequent leads led NCB to a stockist in Roorkee and an associate in Delhi's Mayur Vihar. Further investigation uncovered a key contact in Udupi, Karnataka, who managed bulk orders for exports. Analysis of seized data from Udupi revealed 50 international consignments 29 within the US, 18 within Australia, and one each to Estonia, Spain, and Switzerland. This intelligence was shared with international counterparts and the International Criminal Police Organisation (Interpol). Acting on this information, the United States Drug Enforcement Administration (DEA) arrested a key operative named Joel Hall, a re-shipper based in Alabama. Authorities seized over 17,000 tablets of controlled medicines from his possession. Multiple crypto wallets and active parcels were recovered, confirming the network's reliance on digital currency and encrypted communications. DEA also intercepted five parcels carrying around 700 grams of Zolpidem, a sedative commonly abused for recreational use. Meanwhile, a clandestine pill-manufacturing facility linked to the network was busted in Australia by local law enforcement. The factory was found producing tablets for export as part of the syndicate's supply chain. Investigations in other countries are ongoing. NCB's probe uncovered a multilayered structure with two distinct modules, orders and supply, managed by handlers using encrypted messaging platforms like Telegram and payment systems involving cryptocurrency, PayPal, and Western Union. The syndicate operated a call centre in Udupi, employing approximately 10 staff members, some of whom were reportedly unaware of the criminal operation. Orders placed via the B2B platform were routed through this call centre. Advance payments were made in cryptocurrency, then circulated through supply chain operators who retained a commission before the payments were disbursed to re-shippers in various countries. According to the NCB, the mastermind who orchestrated the network's logistics and finances from the UAE has been identified, and efforts are ongoing to apprehend him with the assistance of Emirati authorities. Two more Indian nationals were arrested in Jaipur and Delhi in connection with the logistics and supply-side operations. So far, a total of eight individuals have been arrested. In a strategic move to expand operations, repeat customers were converted into stockists or re-shippers, allowing the syndicate to grow its footprint organically across borders. Several such individuals have been identified by partner agencies abroad. NCB has also launched financial and cyber investigations to trace cryptocurrency wallets and hawala channels involved in laundering proceeds. Collaborations are underway with private online platforms to shut down illegal pharmacy listings advertising controlled drugs. This case, authorities say, underlines the growing intersection of digital commerce, encrypted technology, and international logistics in facilitating illicit pharmaceutical trade. It also reinforces the importance of international intelligence-sharing and collaborative enforcement actions.

11 Sep 2024

·medcitynews.com

300+ Provider Organizations Urge Feds to Prevent Leaked DEA Rule From Going into Effect - MedCity News

More than 330 healthcare organizations signed letters this week urging the White House and Congress to extend a telehealth prescribing flexibility that was introduced during the Covid-19 pandemic. Failure to extend this policy would cause millions of Americans to lose access to “critically important healthcare treatment,” the organizations wrote. In 2020, Congress waived a rule that required an in-person visit to establish a relationship between a patient and their provider before any prescriptions can be given via telehealth. The Drug Enforcement Administration had originally planned to roll back this flexibility last year, but the agency extended it through the end of 2024 after receiving more than 38,000 comments on its proposed rule. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani For nearly four years now, providers have been using the telehealth prescribing flexibility to prescribe controlled substances. These include Schedule II drugs, such as stimulant medications to treat ADHD like Adderall and Vyvanse, as well as opioids like Percocet and Dilaudid. These also include Schedule III-V controlled substances, such as common psychiatric drugs like Xanax, Ambien and Prozac, as well as drugs that treat substance use disorder like buprenorphine. The DEA is still working on a new proposed rule that will dictate whether or not providers can prescribe controlled substances via telehealth after this year — but last week, its plans were leaked by media outlets. The agency’s rule — which is not final and is currently being reviewed at the White House — is definitely not what telehealth advocates were calling for. The rule would get rid of providers’ ability to prescribe Schedule II drugs via telehealth without a prior in-person appointment — either by establishing new regulations or simply allowing the pandemic-era flexibility to expire at the end of the year. On the other hand, Schedule III-V drugs would still be allowed to be prescribed via telehealth without an in-person visit. Sponsored Post What Healthcare Can Learn from Costco The path forward is clear: employers must evaluate their health plan the same way they do their Saturday shopping excursion. By Jeff Bak, Imagine360 CEO and President Additionally, the unpublished rule would require that no more than half of a provider’s prescriptions may be given via telehealth appointment. It also includes a mandate for prescribers to check all 50 states’ prescription drug monitoring programs before writing a prescription for a patient with whom they have never had an in-person visit. However, enforcing this requirement will be difficult, as providers say there is no national registry where providers could easily check whether or not the patient had obtained a prescription for the drug in another state. Many provider organizations have reacted to the leaked rule with outrage. On Tuesday, more than 300 groups sent separate letters to the White House, Senate and House, imploring them to roll back the strict rules that the DEA is reportedly planning to propose. Some of these organizations included Amazon, Cleveland Clinic, Mass General Brigham, Hims & Hers Health, the American College of Physicians, and the National Rural Health Association. “The ongoing challenges in accessing mental health and substance use treatment services, particularly in rural and underserved areas, underscore the importance of maintaining these flexibilities. More than half of U.S. counties do not have a psychiatrist. The shortage is even more prominent in rural areas, with nearly three quarters of rural counties lacking a psychiatrist,” read the groups’ letter to the White House. Extending the prescribing flexibility would mean that millions of patients in these underserved areas would get to keep their access to treatment, the organizations argued in their letter. The letter also pointed out that there is very little time to make this happen. “Given how late we are in the year and with the waiver expiring on December 31, there is very little time left for the DEA to release a draft rule for public comment, close the comment period, review the substantive feedback, and finalize the rule in time for the end of the year. Nearly 40,000 comments were submitted last year when the DEA first attempted to draft rules for a permanent framework on remote prescribing of controlled substances,” it read.

100 Deals associated with Zolpidem Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
D00706	Zolpidem Tartrate	N05CF02	DB00425

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	United States	Cosette Pharmaceuticals, Inc.	16 Dec 1992

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	Phase 3	United States	Sanofi	01 Apr 2006
Attention Deficit Disorder With Hyperactivity	Phase 3	Canada	Sanofi	01 Apr 2006
Bipolar Disorder	Phase 3	Japan	Astellas Pharma, Inc.	01 Mar 2006
Schizophrenia	Phase 3	Japan	Astellas Pharma, Inc.	01 Mar 2006
Chronobiology Disorders	Clinical	United States	Sanofi	01 Dec 2008
Dementia due to Alzheimer's disease (disorder)	Clinical	United States	Sanofi	01 Dec 2008
Dementia, Vascular	Clinical	United States	Sanofi	01 Dec 2008

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03774810 (R01, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders	197	Zolpidem Tartrate (QHS-FD (Phase 1))	eserxlgmko = hwtlxjsxsy drzrjyxbbr (chpqvbxziy, ppbxgqbfko - dcmprmaxpq) View more	-	09 May 2025
				Zolpidem Tartrate (Partial Reinforcement 1 (PR1) (Phases 2 & 3))	jsokxsypjm = xwwkaslzhg kdnznwlxwh (ougxbwuosm, rfofemplgl - brkqnkcqji) View more
NCT04263909 (CTgov)	Phase 4	Pain, Postoperative	199	Sublingual Tablet	przyubodnu(nlymyfxyqw) = wceamchzql pxsenfecsq (ivreyfkuth, 2.42) View more	-	30 Mar 2025
NCT04468776 (COZI, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders	155	Zolpidem+Trazodone (Medication (Zolpidem or Trazodone))	mytwsqisfj(tqfukdyjqx) = spszztvioa qcnexfgnjo (gosgjoekgq, azmzmmecbt - hpcqokvqpi) View more	-	24 Feb 2025
				Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Internet Cognitive Behavioral Therapy for Insomnia (CBT-I))	mytwsqisfj(tqfukdyjqx) = wnbjkvfiqy qcnexfgnjo (gosgjoekgq, imqjjiqsor - ncohiolwxo) View more
NCT02456532 (CIS2, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders	41	placebo (Placebo)	lumeejqnts(acxfnjcpwf) = sarvhqglmt ltkfsqebys (fydlnlpkdx, 1.6) View more	-	29 Mar 2024
				Zolpidem CR (Zolpidem CR)	lumeejqnts(acxfnjcpwf) = lzoedqvqer ltkfsqebys (fydlnlpkdx, 4.5) View more
WSC2023	Not Applicable	Sleep Initiation and Maintenance Disorders	716	Lemborexant	fjriffofmi(vgttltigdl) = scmfacnwhd ciokjjdvhn (vwvepnxxdu )	Positive	23 Oct 2023
				Trazodone	fjriffofmi(vgttltigdl) = mvaevxfyku ciokjjdvhn (vwvepnxxdu )
NCT02783729 (Study 304, AAN2022)	Phase 3	Sleep Initiation and Maintenance Disorders	1,006	Lemborexant 5mg	kiqnzprfba(fkniqkhldt) = vgclbcuysg ydocgoogdb (ptlhoejbub ) View more	-	03 May 2022
				Lemborexant 10mg	kiqnzprfba(fkniqkhldt) = lfoowwosmq ydocgoogdb (ptlhoejbub ) View more
NCT04720547 (Pubmed \| Sleep Breath)	Phase 4	Sleep Wake Disorders \| Sleep Apnea, Central	14	Zolpidem 5 mg	kuirazcfgl(vwveubtjym) = alyunwneav uqxmenjppx (zbxbszzqgm, 4.4) View more	Positive	14 Mar 2022
				No medication	kuirazcfgl(vwveubtjym) = qvpgagqkiz uqxmenjppx (zbxbszzqgm, 7.7) View more
NCT03075241 (Pubmed \| Neuropsychopharmacology)	Phase 3	Alzheimer Disease	62	Zopiclone 7.5 mg/day	mxwkeliciz(pezphrkntq) = wsjljtqxiv cerhqdyjpr (xtsjqurfxl, -0.8 to 163.2) View more	-	11 Oct 2021
Tandem Meetings ASTCT and CIBMTR2020	Not Applicable	Multiple Myeloma	-	Benzodiazepines	mvchzvlhjz(xscxdwznso) = cxptopgsmt kcfhljkzhk (qjimrmhwtn ) View more	-	01 Mar 2020
				Zolpidem	mvchzvlhjz(xscxdwznso) = kkgyupydcc kcfhljkzhk (qjimrmhwtn ) View more

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