[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of ramelteon tablets in the treatment of insomnia with difficulty falling asleep in Chinese adults

主要目的：以安慰剂对照，评估雷美替胺片治疗中国成人入睡困难型失眠症的有效性。次要目的：以安慰剂对照，评估雷美替胺片治疗中国成人入睡困难型失眠症的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of ramelteon tablets in the treatment of insomnia with difficulty in falling asleep in Chinese adults by placebo control. Secondary objective: To evaluate the safety of ramelteon tablets in the treatment of insomnia with difficulty in falling asleep in Chinese adults by placebo control.

Start Date15 Aug 2025

Sponsor / Collaborator

Sichuan Credit Pharmaceutical Co., Ltd.

CTR20251933

/ Active, not recruitingNot Applicable

雷美替胺片人体生物等效性研究

[Translation] Study on the bioequivalence of ramelteon tablets in healthy volunteers

本试验旨在研究单次空腹口服广州绿十字制药股份有限公司研制、生产的雷美替胺片（8 mg）的药代动力学特征；以武田薬品工業株式会社持证、生产的雷美替胺片（Rozerem®，8 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to study the pharmacokinetic characteristics of a single fasting oral dose of ramelteon tablets (8 mg) developed and produced by Guangzhou Green Cross Pharmaceutical Co., Ltd.; using ramelteon tablets (Rozerem®, 8 mg) licensed and produced by Takeda Pharmaceutical Industries, Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

Start Date27 May 2025

Sponsor / Collaborator

Guangzhou Green Cross Pharmaceutical Co., Ltd.

CTR20242594

/ CompletedNot Applicable

雷美替胺片人体生物等效性研究

[Translation] Study on the bioequivalence of ramelteon tablets in healthy volunteers

采用单中心、随机、开放、四周期完全重复交叉、单剂量给药设计，比较空腹和餐后给药条件下，四川科瑞德制药股份有限公司生产的雷美替胺片（规格：8 mg）与武田薬品工業株式会社持证生产的雷美替胺片（规格：8 mg，商品名：Rozerem®）在中国健康成年受试者中吸收程度和吸收速度的差异，评价空腹和餐后状态下口服两种制剂的生物等效性，并评价四川科瑞德制药股份有限公司生产的雷美替胺片（规格：8 mg）的安全性。

[Translation]

A single-center, randomized, open, four-cycle fully repeated crossover, single-dose dosing design was used to compare ramelteon tablets (specification: 8 mg) produced by Sichuan Creide Pharmaceutical Co., Ltd. under fasting and postprandial dosing conditions. ) and ramelteon tablets (specification: 8 mg, trade name: Rozerem®) produced by Takeda Pharmaceutical Co., Ltd. with a license in Chinese healthy adult subjects, to evaluate the difference in the degree and rate of absorption between fasting and postprandial states The bioequivalence of the two oral preparations was studied, and the safety of ramelteon tablets (specification: 8 mg) produced by Sichuan Creide Pharmaceutical Co., Ltd. was evaluated.

Start Date12 Aug 2024

Sponsor / Collaborator

Sichuan Credit Pharmaceutical Co., Ltd.

100 Clinical Results associated with Ramelteon

100 Translational Medicine associated with Ramelteon

100 Patents (Medical) associated with Ramelteon

664

Literatures (Medical) associated with Ramelteon

01 Dec 2025·Sleep medicine: X

Self-reported sleep variables, sleep quality, and quality of life assessment in transition to lemborexant in patients with Insomnia: the multicenter, open-label SOMNUS study

Article

Author: Ohshima, Hayato ; Uchimura, Naohisa ; Hirota, Susumu ; Murotani, Kenta ; Hayashida, Kenichi ; Koebis, Michinori ; Habukawa, Mitsunari ; Taninaga, Takehiro ; Ariyoshi, Yu ; Harada, Daisuke ; Ozone, Motohiro ; Ikegami, Azusa ; Hiejima, Hiroshi ; Kotorii, Nozomu ; Nishi, Yurie

Aims:

Lemborexant, a dual orexin receptor antagonist, is approved for treating adults with insomnia. We present diary-based sleep parameters, self-reported sleep quality, insomnia severity, and health-related quality of life following direct transition to lemborexant from previous treatment in Japanese patients with insomnia using data from the SOMNUS Study.

Methods:

The prospective, nonrandomized, open-label, multicenter SOMNUS Study analyzed data from 90 patients across four cohorts of direct switching to lemborexant from Z-drugs (monotherapy cohort: n = 25), suvorexant (monotherapy cohort: n = 25, combination cohort: n = 21), and ramelteon (combination cohort: n = 19) up to 14 weeks.

Results:

Diary-based sleep parameters (subjective sleep onset latency, subjective wake time after sleep onset, subjective total sleep time, and subjective sleep efficiency) significantly improved after transitioning to lemborexant in the 90 patients. At 2, 6, and 14 weeks, significant reductions in Insomnia Severity Index total scores were observed (-2.6 ± 3.81, -4.4 ± 5.13, and -5.3 ± 4.80, respectively; all p < 0.0001). Self-reported sleep quality and morning alertness also showed consistent, significant improvements across all time points. Short Form-8 physical component summary and mental component summary scores demonstrated positive trends, with notable improvements observed in the overall population by the end of the study. Treatment-emergent adverse events (TEAEs) occurred in 47.8 % of patients; most were mild or moderate in severity. No serious TEAEs occurred; somnolence was the most common TEAE.

Conclusions:

These findings indicate that transitioning to lemborexant from previous insomnia treatment is efficacious in improving sleep parameters, insomnia severity, and health-related quality of life, with a favorable safety profile.

Trial registration:

NCT04742699.

01 Nov 2025·GENERAL HOSPITAL PSYCHIATRY

Falls and fractures associated with ramelteon use: A systematic review and meta-analysis

Review

Author: Nakano, Yuki ; Tateishi, Hiroshi ; Shimanoe, Chisato ; Mizoguchi, Yoshito ; Sogawa, Rintaro ; Kotake, Kazumasa ; Monji, Akira

INTRODUCTION:

Hypnotics are associated with increased risk of falls and fractures. However, most studies evaluating the association between ramelteon, and these outcomes, are single-center and lack comprehensive analysis. We aimed to evaluate the association between ramelteon use and the risk of falls and fractures.

METHODS:

We systematically searched for the term "ramelteon" in the Medical Literature Analysis and Retrieval System Online via PubMed, Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform, and ClinicalTrials.gov. in January 7, 2025. Retrieved studies were assessed for risk of bias and analyzed for the association between ramelteon use and falls or fractures using a random-effects model based on the Sidik-Jonkman method, as well as inter-study heterogeneity using the I² statistic. Meta-analyses were conducted on seven observational studies and three randomized controlled trials.

RESULTS:

Ramelteon use was not significantly associated with an increased fall risk (odds ratio: 1.26; 95 % confidence interval: 0.83-1.92; I² = 0 %). Analysis of fractures showed a potential increased risk with ramelteon use (risk ratio: 3.29; 95 % confidence interval: 0.53-20.45; I² = 0 %), although this was not statistically significant.

CONCLUSION:

Ramelteon was not associated with a statistically significant increase in the risk of falls or fractures, regardless of the study design.

01 Sep 2025·JOURNAL OF PINEAL RESEARCH

Sequence Symmetry Analysis of the Interrelationships Between Ramelteon and Parkinson's Disease

Article

Author: Masuda, Rikuto ; Yoshimura, Tomoaki ; Noguchi, Yoshihiro

ABSTRACT:

Parkinson's disease is the second most frequent neurodegenerative disease after Alzheimer's disease, and the most common neurodegenerative disease that causes movement dysfunction. Without innovations in prevention and treatment, the incidence and prevalence of Parkinson's disease is projected to increase by > 30% by 2030, making the development of new treatments an urgent priority. We previously investigated the association between melatonin receptor agonists and Parkinson's disease using the US Food and Drug Administration's Adverse Event Reporting System (FAERS). The results showed that ramelteon may reduce the incidence of Parkinson's disease. However, since the US FAERS relies on spontaneous reports, which are susceptible to reporting bias, further validation using real‐world data is required. This study investigated the association between ramelteon use and risk of developing Parkinson's disease using the DeSC database, a Japanese claims database reported to be representative of the general Japanese population. The association was evaluated using sequence symmetry analysis, with the adjusted sequence ratio (ASR) serving as the evaluation index. Our DeSC database analysis showed a negative association between ramelteon use and Parkinson's disease (ASR: 0.959, 95% confidence interval: 0.955–0.964). Our results support previous reports suggesting that ramelteon may help suppress the onset of Parkinson's disease. However, even though this study used real‐world data, these results should be interpreted with caution, as a sequence symmetry analysis cannot be adjusted for covariates. Therefore, additional pharmacoepidemiological studies are needed to further verify the potential risk of Parkinson's disease associated with ramelteon use.

News (Medical) associated with Ramelteon

03 Jun 2025

·www.enveric.com

Enveric Biosciences Announces Issuance of U.S. Patent Covering a Novel Family of Molecules Including Melatonin Receptor-Targeting Compounds

CAMBRIDGE, Mass. – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today announced the issuance of a new U.S. patent (USPTO Number 12,187,679). The patent strengthens Enveric’s intellectual property portfolio and covers a structurally diverse class of novel molecules with potential therapeutic applications in the treatment of sleep and central nervous system (CNS) disorders. The newly granted patent, titled, “Hydroxylated Psilocybin Derivatives and Methods of Using,” expands Enveric’s proprietary drug discovery platform and includes a unique subset of compounds that demonstrate selective binding to the melatonin MT1 receptor-an established, therapeutic target known to regulate circadian rhythm and sleep-wake cycles. These molecules were identified through Enveric’s structure-activity screening efforts. Melatonin signaling is a clinically validated pathway in the treatment of sleep and mood disorders. Several approved therapies leverage this mechanism of action, including ramelteon (Rozerem®), a selective MT1/MT2 agonist approved by the FDA for insomnia, and agomelatine (Valdoxan®), an MT1/MT2 agonist and 5-HT C antagonist approved in Europe for major depressive disorder (MDD). These drugs provide market validation for targeting melatonergic pathways. Among the diverse molecules covered by the patent, select compounds exhibit potential to act as MT1-selective agonists, positioning them as promising candidates for the development of innovative sleep therapeutics. Some of these compounds also display more complex pharmacological profiles, engaging both melatonin and other CNS-relevant receptor systems. This receptor diversity may enable differentiated therapeutic approaches across a range of psychiatric and neurological indications. The Company believes this new patent enhances the strength of its drug discovery platform and supports continued expansion of its CNS-focused strategy targeting high-value therapeutic markets. Dr. Joseph Tucker, CEO of Enveric Biosciences, commented “This newly issued patent adds to the growing body of intellectual property that underpins our pipeline of next-generation neuroplastogenic therapeutics. The inclusion of selective melatonin receptor-binding compounds broadens our ability to target sleep disorders, a prevalent category representing a multi-billion-dollar annual market. This intellectual property milestone strengthens our strategic position to advance differentiated candidates in areas where current treatment options remain limited or suboptimal.” About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com. Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250603483507/en/ Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 dirish@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 cmcdonald@tiberend.com

Drug Approval

27 Jan 2025

·www.globenewswire.com

Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree®, Including New Pharmacodynamic Data and Information for Breastfeeding Women

Updated label includes new data in Section 12.2, detailing serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition, highlighting Qelbree’s multimodal pharmacodynamicsQelbree is the first ADHD treatment to meet its post marketing requirement and receive labeling approval following the 2019 FDA guidance on Clinical Lactation Studies1 ROCKVILLE, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2. The updated label describes viloxazine’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. Additionally, the updated label now includes new lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low. Qelbree is approved for use in patients ages 6 years and older with ADHD. “This label update and new data deepens our understanding of Qelbree, providing valuable insights to help support treatment decision-making for people living with ADHD,” says Dr. Stephen M. Stahl, M.D., PhD, DSc (Hon.) Distinguished Health Sciences Clinical Professor of Psychiatry and Neuroscience, University of California Riverside and Adjunct Professor of Psychiatry, University of California San Diego. “The updated pharmacodynamic data, which highlights viloxazine’s effects on the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, adds depth to our understanding of Qelbree’s multimodal pharmacodynamics.” The update to include lactation data in the label (Section 8.2) follows the 2019 FDA guidance suggesting lactation studies be conducted to inform breastfeeding with drug use recommendations and is based on a study involving 15 healthy lactating women.¹ The study evaluated the secretion of viloxazine and its metabolite (5-HVLX-gluc) into breast milk following a multi-dose (600 mg daily for three days) regimen of viloxazine. Results showed that the estimated daily infant dose (using a nominal infant body weight of 6 kg) of viloxazine and 5-HVLX-gluc was 0.085 mg/kg and 0.00595 mg/kg, respectively, and the relative infant dose was approximately 1% and 0.07%, respectively, of the weight-normalized maternal daily dose (8.58 mg/kg) of viloxazine. These data support that the transfer of viloxazine into breastmilk is low. The study did not specifically evaluate the effects of viloxazine on breastfed infants or milk production, nor is there additional data regarding these effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qelbree and any potential adverse effects on the breastfed child from Qelbree or from the underlying maternal condition. “By expanding Qelbree’s label to include new data on the pharmacodynamics and use in breastfeeding mothers, Supernus continues to empower healthcare providers and patients to make informed treatment decisions,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We are committed to building the body of evidence surrounding Qelbree’s use within the ADHD space and providing an effective treatment option for those living with ADHD.” INDICATION Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATION Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child: Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning and Medication Guide, for Qelbree here. ¹U.S. Food and Drug Administration. (2019). Clinical Lactation Studies: Considerations for Study Design. Guidance for Industry. Retrieved from https://www.fda.gov/media/124749/download. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s Disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. Forward Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s reporting on preliminary and exploratory open label clinical study on SPN-820, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s ability to conduct and progress product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-820 and SPN-830; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates including SPN-820; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates including SPN-820; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591 Or INVESTOR CONTACT: Peter VozzoICR Healthcare(443) 213-0505Peter.Vozzo@icrhealthcare.com MEDIA CONTACT: Catherine Fabiano(646) 384-9617Catherine.Fabiano@bcw-global.com

Clinical ResultDrug Approval

24 Sep 2024

·www.globenewswire.com

Busy Philipps Encourages Women to Take Charge of Their ADHD This Fall in Ongoing Collaboration with Supernus Pharmaceuticals and Qelbree

Ahead of ADHD Awareness Month, Busy is sharing her ADHD diagnosis and Qelbree® (viloxazine extended-release capsules) treatment story to empower women living with ADHD to advocate for their care.ADHD often presents differently in women than in men, which can make it more challenging to recognize in women and ultimately leaving them undiagnosed and untreated.1 ROCKVILLE, Md., Sept. 24, 2024 (GLOBE NEWSWIRE) -- In a continued collaboration with Supernus Pharmaceuticals, actress, author, podcaster, late-night host, and mom, Busy Philipps, is speaking up this fall about her ongoing journey with attention-deficit/hyperactivity disorder (ADHD), bringing awareness to the often-overlooked symptoms of the condition in women and Qelbree, a non-stimulant ADHD treatment that has benefitted her. With summer over and the school year now in full swing, the fall season brings for many adults a return to normal routines or schedules, as well as an opportunity for a fresh start. Busy knows first-hand just how difficult getting ‘back to schedule’ can be for the approximately 10 million adults living with ADHD, who may be experiencing symptoms of inattention, hyperactivity/impulsivity, or both.2 She’s sharing her story to help empower people, and especially women, living with ADHD to take action for a fresh start this fall and talk to their doctors about treatment options to help manage their condition. “For many years living with unmanaged ADHD, I’d often start a task and never remember to finish, frequently feeling restless and unable to stay still. I would ramble on, get easily distracted and have trouble multitasking, and with my busy lifestyle, it was a challenge,” says Busy. “Now that I’m taking Qelbree, I’m relieved that my ADHD symptoms are more manageable. I only wish I’d taken charge of my ADHD sooner. That’s why I’m sharing my story to raise awareness about ADHD and help others who may be struggling with their diagnosis find a treatment option that works for them like Qelbree has worked for me.” Qelbree is a novel, once-a-day, non-stimulant approach for patients 6 years and older with ADHD, and the first non-stimulant approved for adults with ADHD in 20 years. As a non-stimulant, Qelbree has no evidence of abuse or misuse and can be conveniently refilled without needing a new prescription each month. “As a leader in treating ADHD, Supernus is committed to providing treatment options and education to help people living with ADHD like Busy Philipps manage their ADHD symptoms,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We appreciate Busy’s continued support and willingness to share her ADHD story and experience with Qelbree, especially leading into ADHD Awareness Month.” For more information about Qelbree, visit Qelbree.com. Patients should speak to a doctor about all the medications they take, and to see if Qelbree could be right for them. INDICATION Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATION Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child: Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning, for Qelbree here. 1Holthe, M. E. G., Langvik, E. (2017). The Strives, Struggles, and Successes of Women Diagnosed with ADHD as Adults. SAGE Journals. 2Culpepper, L., Mattingly, G. (2010). Challenges in Identifying and Managing Attention-Deficit/Hyperactivity Disorder in Adults in the Primary Care Setting: A Review of the Literature. Primary Care Companion Journal of Clinical Psychiatry. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. CONTACTS: Jack A. Khattar, President and CEO Timothy C. Dec, Senior Vice President and CFO Supernus Pharmaceuticals, Inc. Tel: (301) 838-2591 Or INVESTOR CONTACT: Peter Vozzo ICR Westwicke Office: (443) 213-0505 Email: Peter.Vozzo@westwicke.com MEDIA CONTACT: Matthew FrappierTel: (646) 358-9683Email: Matthew.Frappier@bcw-global.com

Drug Approval

100 Deals associated with Ramelteon

External Link

KEGG	Wiki	ATC	Drug Bank
D02689	Ramelteon	N05CH02	DB00980

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	United States	Takeda Pharmaceuticals U.S.A., Inc.	22 Jul 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Argentina	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Chile	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Colombia	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Mexico	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Asthma	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Mar 2008
Bipolar I disorder	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Dec 2007
Sleep Apnea, Obstructive	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Jul 2006
Migraine With Aura	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Apr 2008
Migraine Without Aura	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Apr 2008

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03091738 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Fibrosis	10	Ramelteon Pill	elbostyhwi(nvyxscfuws) = lwoxfchrxy mxunlmizit (trszclutvc, 2.97) View more	-	29 Mar 2021
NCT02324153 (RECOVER, CTgov)	Phase 2	Anesthesia \| Emergence Delirium \| Cognition Disorders	80	Microcrystalline Cellulose+Ramelteon+Riboflavin 100 mg (Treatment)	potojmxktt = dkmepmgejp xvftzkdcfi (nmyogqmlon, iyfswxapew - qkdrhfxhet) View more	-	30 Jun 2020
				Microcrystalline Cellulose+Riboflavin 100 mg (Placebo)	potojmxktt = mfddaeflgc xvftzkdcfi (nmyogqmlon, spypkxczfx - mfdpwaxtdt) View more
NCT02324153 (RECOVER, Pubmed \| Am J Geriatr Psychiatry)	Phase 2	Emergence Delirium	80	Ramelteon (8 mg)	ribhjhqvww(lqqcuioedb) = kengsvflip ynavedxkdu (xlvjrltito )	Negative	16 May 2020
				Placebo	ribhjhqvww(lqqcuioedb) = ecbvhxtxwk ynavedxkdu (xlvjrltito )
NCT02691013 (Pubmed \| Crit Care Med)	Not Applicable	-	-	Ramelteon 8mg	grfyjfwzrv(gpwajsdbql) = cubikbguxj qutmwbmdet (conwqkpfes ) View more	Negative	01 Dec 2019
				Placebo	grfyjfwzrv(gpwajsdbql) = hsxfinojpj qutmwbmdet (conwqkpfes ) View more
NCT02560324 (RAP, CTgov)	Phase 2	Tobacco Use Disorder	140	Ramelteon (Ramelteon)	aybykhuhas(riumwjrxaz) = vrxjccgjhm ycehnrsmba (vdumghbjwp, 1.6) View more	-	04 Nov 2019
				Placebo (Placebo)	aybykhuhas(riumwjrxaz) = docruhjccs ycehnrsmba (vdumghbjwp, 1.6) View more
NCT02691013 (CTgov)	Not Applicable	Pulmonary Embolism \| Delirium \| Sleep Deprivation	120	Placebo (Placebo)	nxfxafqslu(edpejrwwjw) = fdfutlnmso pjulqalfef (usbabqigun, vszagmwuuq - zaiefwhexl) View more	-	20 Sep 2019
				Ramelteon (Ramelteon)	nxfxafqslu(edpejrwwjw) = ftmwaaqmjl pjulqalfef (usbabqigun, nujhxpbtlw - rixluxvsrq) View more
NCT02669082 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Depressive Disorder, Major	26	Ramelteon	febklrsige(drsnymtjhs) = pahkjctofn gzqdcxppmb (sckkfjrbss, 32.498) View more	-	22 Jul 2019
NCT01048242 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep Apnea, Obstructive	27	rozerem (Ramelteon)	vytirsvyew(jfjtnzpenp) = iisgsithyq lpafntukfl (hseqctxjbr, 10.3) View more	-	03 May 2017
				Placebo (Sugar Pill)	vytirsvyew(jfjtnzpenp) = upcnnuihjm lpafntukfl (hseqctxjbr, 30.7) View more
NCT01467700 (CTgov)	Phase 3	Depressive Disorder \| Bipolar I disorder \| Depressive Disorder, Major	490	Placebo (Placebo)	crcfqzolkk(tkghnxwkdy) = kjfrnorbcu fbqmjcvfha (zzfrvjmrrb, 0.94) View more	-	16 May 2016
				Ramelteon SL (Ramelteon SL 0.1 mg)	crcfqzolkk(tkghnxwkdy) = titeycaamp fbqmjcvfha (zzfrvjmrrb, 0.89) View more
NCT01467713 (CTgov)	Phase 3	Bipolar I disorder	642	Placebo (Placebo)	byolyzflei(lhpwqvtkja) = eqlyskrjnk ngtpfszksy (fisbgvgdkh, 8.11) View more	-	16 May 2016
				Ramelteon SL (Ramelteon SL 0.1 mg)	byolyzflei(lhpwqvtkja) = wvgrwecvmf ngtpfszksy (fisbgvgdkh, 8.83) View more

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