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Last update 20 Dec 2025

Zolpidem Tartrate

Last update 20 Dec 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

175

Clinical Trials associated with Zolpidem Tartrate

CTRI/2025/10/095548

/ Not yet recruitingNot Applicable

Evaluation of the comparative efficacy of Sahadevi Ghan Vati versus Tablet Zolpidem in the management of Anidra ( Primary Insomnia)- ARandomized Controlled Trial - Nil

Start Date01 Jan 2026

Sponsor / Collaborator-

ChiCTR2500111601

/ Not yet recruitingNot Applicable

Efficacy and mechanism of simultaneous combining of transcranial direct current stimulation and zolpidem on patients with treatment-resistant insomnia

Start Date06 Nov 2025

Sponsor / Collaborator-

CTR20250036

/ CompletedPhase 3

评估YZJ-1139片治疗失眠症的有效性和安全性的随机、双盲、阳性药物平行对照临床试验

[Translation] A randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of YZJ-1139 tablets in the treatment of insomnia

主要目的：评估连续28天服用YZJ-1139片在失眠症患者中的有效性。次要目的：评估连续28天服用YZJ-1139片在失眠症患者中的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of YZJ-1139 tablets in patients with insomnia after taking them for 28 consecutive days. Secondary objective: To evaluate the safety of YZJ-1139 tablets in patients with insomnia after taking them for 28 consecutive days.

Start Date25 Mar 2025

Sponsor / Collaborator

Yangtze River Pharmacy Group Jiangsu Haici Biological Pharmacy

[+2]

100 Clinical Results associated with Zolpidem Tartrate

100 Translational Medicine associated with Zolpidem Tartrate

100 Patents (Medical) associated with Zolpidem Tartrate

4,846

Literatures (Medical) associated with Zolpidem Tartrate

01 Dec 2025·SLEEP MEDICINE

Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysis

Review

Author: Wang, Ying ; Liu, Hui ; Zhu, Bing ; Wang, Hongfeng ; Liu, Xiaoge ; Li, Mengyuan ; Chen, Xi

BACKGROUND:

Medications, including dual orexin receptor antagonists (DORAs), benzodiazepines (BZDs), Z-drugs and melatonin receptor agonists, are common medications for insomnia disorder, but holistic comparisons of their efficacy and safety are not quite clear.

OBJECTIVE:

To investigate the efficacy and safety profiles of agents for treating insomnia disorder and further establish a clinical algorithm in terms of type of insomnia based on the "time window" generated from adjusting for certain confounding factors.

METHODS:

Relevant randomized controlled trials (RCTs) were retrieved from PubMed, Embase, Scopus, the Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to April 15, 2025. The standard mean difference (SMD) was generated for consecutive variants, including the wake after sleep onset(WASO), latency to persistent sleep(LPS), total sleep time(TST), and sleep efficiency(SE), for pairwise comparisons via Bayesian network meta-regression (NMR) analyses adjusted for the follow-up period and age by RStudio 4.4.2. Pharmacovigilance (PV) was investigated by leveraging the FAERS database, and odds ratios (ORs) were generated for dichotomous and ordinal variants for pairwise comparisons via STATA 18.0 MP.

RESULT:

A total of 15 studies evaluating 10 treatment regimens involving 2408 patients were included in the final analysis. For the WASO, compared with the placebo group, dimdazenil 2.5 mg/d (SMD = -0.388, 95 % CI: -0.608 to -0.166), lemborexant 10 mg/d (SMD = -0.624, 95 % CI: -0.894 to -0.355), lemborexant 5 mg/d (SMD = -0.612, 95 % CI: -0.88 to -0.342), daridorexant 25 mg/d (SMD = -0.957, 95 % CI: -1.436 to -0.479), melatonin 6 mg/d (SMD = -0.741, 95 % CI: -1.423 to -0.044), zolpidem 10 mg/d (SMD = -0.348, 95 % CI: -0.61 to -0.068), doxepin 3 mg/d (SMD = -0.497, 95 % CI: -0.713 to -0.282) were significantly superior. Among the effective regimens, lemborexant 10 mg/d, lemborexant 5 mg/d, daridorexant 25 mg/d, melatonin 6 mg/d, and doxepin 3 mg/d were comparable. However, dimdazenil 2.5 mg/d (SMD = 0.568, 95 % CI: 0.046 to 1.096) and zolpidem 10 mg/d (SMD = 0.608, 95 % CI: 0.074 to 1.171) were significantly inferior to daridorexant 25 mg/d.After adjusting for the follow-up period, the results resembled those of the raw analysis except for the loss of significant superiority of melatonin 6 mg/d (SMD = -0.727, 95 % CI: -1.48 to 0.01) over the placebo. However, melatonin 6 mg/d demonstrated a "time window" of significant superiority over the control group from the 10^th to 40^th weeks. After adjusting for age, dimdazenil 2.5 mg/d (SMD = -0.355, 95 % CI: -0.652 to -0.1), lemborexant 10 mg/d (SMD = -0.508, 95 % CI: -0.9 to -0.114), zolpidem 10 mg/d (SMD = -0.526, 95 % CI: -0.84 to -0.158) demonstrated significant superiority over placebo. In terms of safety, with respect to nervous system disorders, safety signals were detected in suvorexant (IC₀₂₅ = 0.212; 95 % CI: 1.214 to 1.334), lemborexant (IC₀₂₅ = 0.221; 95 % CI: 1.236 to 1.567), daridorexant (IC₀₂₅ = 0.205; 95 % CI: 1.21 to 1.427) and doxepin (IC₀₂₅ = 0.066; 95 % CI: 1.091 to 1.411). In terms of dyspnoea, eszopiclone (OR ranging from 0.556 to 0.669) had significantly lower constituent ratios than daridorexant, melatonin and zolpidem did. Melatonin (OR = 1.568, 95 % CI = 1.192 to 2.061, p = 0.001) and zolpidem (OR = 1.302, 95 % CI = 1.026 to 1.653, p = 0.03) had a significantly higher constituent ratio than suvorexant. The proportion of patients with severe dyspnoea caused by daridorexant (OR = 0.256, 95 % CI = 0.096 to 0.678, p = 0.006) was significantly lower than that caused by suvorexant and lemborexant. For adverse reaction outcomes, zaleplon (OR = 9.888, 95 % CI = 1.124 to 86.944, p = 0.039) had a significantly higher effect than daridorexant on severe dyspnoea.

CONCLUSION:

Comprehensively considering the efficacy effect size, time windows (follow-up period, age, and types of insomnia), PV, severity of imperative adverse events, we propose prioritizing the use of daridorexant 25 mg/d for insomnia characterized by difficulty maintaining sleep and insufficient sleep duration. For insomnia characterized by difficulty falling asleep, we recommend prioritizing the use of lemborexant 10 mg/day or zolpidem 10 mg/day. For overall poor sleep efficiency, we recommend using lemborexant. Drug selection should be based on the types of insomnia and drug safety. More head-to-head clinical trials are needed to confirm those findings.

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 Dec 2025·PCN reports : psychiatry and clinical neurosciences

Psychosis induced by invocation presenting as possession state: A case of Kitousei‐Seishinbyo still emerging in modern Japan

Article

Author: Miyano, Fumiya ; Fujii, Yutaka ; Kato, Takahiro A. ; Mitsui, Nobuyuki

Abstract:

Background:

Kitousei‐Seishinbyo, or psychosis induced by invocation, was first described by Morita in 1915 as a culture‐bound syndrome characterized by possession‐like states and personality transformation triggered by prayer or spiritual practices. New psychosocial triggers (e.g., self‐improvement seminars, emerging religious groups) have been identified. However, reports of possession‐related episodes have become extremely rare. Diagnostic confusion with dissociative identity disorder or other specified dissociative disorders persists.

Case Presentation:

A woman in her 50s, with no prior psychiatric history, developed acute possession‐like symptoms after visiting a fortune‐teller. She was told her misfortune was caused by the spirit of her aborted child. Soon after, she entered trance states, spoke in altered voices (male and childlike), and exhibited personality changes, agitation, and dangerous behaviors, leading to involuntary admission. On evaluation, laboratory tests, electroencephalogram (EEG), and imaging were unremarkable. During hospitalization, she exhibited mutism, rigidity, temporary auditory hallucinations, and somatic complaints such as heaviness and dizziness, which fluctuated depending on spiritual contact. Retrospective review revealed significant psychosocial stressors, including marital discord, caregiving burden, and strained family relationships. Management involved family psychoeducation, occupational therapy, and low‐dose psychotropics (tandospirone and zolpidem). Her symptoms gradually stabilized, and she voluntarily discontinued spiritual practices. She was discharged after 62 days with improved family dynamics and sustained recovery.

Conclusion:

This case illustrates a present‐day example of Kitousei‐Seishinbyo triggered by encountering a fortune‐teller. Improvement was achieved through combined psychosocial interventions and low‐dose pharmacotherapy.

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.

to view more data

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

Developing

10 top R&D records.

to view more data

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

Evaluation

View All Results

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))	yylpdrnlsy = bpealjnrbt brjbfzrdbp (zrbccqjnep, yiypfjvkaf - ievellnciu) View more	-	09 May 2025
				Zolpidem Tartrate (Partial Reinforcement 1 (PR1) (Phases 2 & 3))	farprryndi = qlmbeeuipb ftgdcmxsex (vkslbnbpvj, ibudfaupnp - ymyboegiuu) View more
NCT04263909 (CTgov)	Phase 4	Pain, Postoperative	199	Sublingual Tablet	djhqqsojoe(uwsxpuppcq) = vyzfuzrytn laomvylcqm (awuzcsgbkq, 2.42) View more	-	30 Mar 2025
NCT04468776 (COZI, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders	155	Zolpidem+Trazodone (Medication (Zolpidem or Trazodone))	dgzxpurdvy(tfxayqtmrs) = cepvqeurgx woarevcqkd (qawglogxys, pnediwznae - mmzxxgyptz) View more	-	24 Feb 2025
				Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Internet Cognitive Behavioral Therapy for Insomnia (CBT-I))	dgzxpurdvy(tfxayqtmrs) = iuewtogtod woarevcqkd (qawglogxys, iswqjaqkmk - pexzljzwcd) View more
NCT03436745 (CTgov)	Phase 1	Prostatic Cancer	12	Zolpidem (Prostate Cancer Cohort: Zolpidem Pre-Castration)	qcmhuhhbag(adwtusmscg) = aphkwedsgt hkdfnkbvbt (xckizhxgkj, lhrsfhbxwt - regjkaxdgw)	-	11 Feb 2025
				Zolpidem (Prostate Cancer Cohort: Zolpidem Post Castration)	qcmhuhhbag(adwtusmscg) = fyhlxotosh hkdfnkbvbt (xckizhxgkj, drukcwtsia - vokdznekds) View more
NCT03657212 (CTgov)	Phase 4	-	10	Nap+Zolpidem (Nap/5mg Zolpidem)	lcgprxfssi(dtnbljtlvp) = vxutrvozda pkixacqslw (pfeutfspph, 3.5) View more	-	05 Feb 2025
				Nap (Nap/Placebo)	lcgprxfssi(dtnbljtlvp) = jlwrfdyxnr pkixacqslw (pfeutfspph, 4.3) View more
NCT02456532 (CIS2, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders	41	placebo (Placebo)	mihilxjgxj(etacqfvkuo) = qwbejwtadr lycyrhfunx (tqvmhtgqao, 1.6) View more	-	29 Mar 2024
				Zolpidem CR (Zolpidem CR)	mihilxjgxj(etacqfvkuo) = psktjefkdx lycyrhfunx (tqvmhtgqao, 4.5) View more
NCT03056053 \| NCT03545191 (Pubmed)	Phase 3	Sleep Initiation and Maintenance Disorders	-	Zolpidem	ixzmmjpkng(crohbvaclm) = srgpbgznos xzpgcqdaol (cmaeygqxfm )	-	01 Feb 2024
				Daridorexant	ixzmmjpkng(crohbvaclm) = ozxbiubdfw xzpgcqdaol (cmaeygqxfm )
WSC2023	Not Applicable	Sleep Initiation and Maintenance Disorders	716	Lemborexant	lvmiasubym(yzmmtajtno) = zcnvocxjwz jzfdjvpesg (ayzpkwclbx )	Positive	23 Oct 2023
				Trazodone	lvmiasubym(yzmmtajtno) = iokupiglay jzfdjvpesg (ayzpkwclbx )
NCT02783729 (Study 304, AAN2022)	Phase 3	Sleep Initiation and Maintenance Disorders	1,006	Lemborexant 5mg	pmziflfipt(zobrppjjln) = uyaobzvbmo jzdseqkntf (dtnfeuqiyz ) View more	-	03 May 2022
				Lemborexant 10mg	pmziflfipt(zobrppjjln) = tfxbaifgmb jzdseqkntf (dtnfeuqiyz ) View more
NCT04720547 (Pubmed \| Sleep Breath)	Phase 4	Sleep Wake Disorders \| Sleep Apnea, Central	14	Zolpidem 5 mg	pysdrwfgbv(vtwxksofdu) = wofpvvjgpz mcekjyodii (eqbagqmnex, 4.4) View more	Positive	14 Mar 2022
				No medication	pysdrwfgbv(vtwxksofdu) = dgouafbior mcekjyodii (eqbagqmnex, 7.7) View more

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