Side Effects of ramelteon: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Major Research Findings

Ramelteon is a melatonin receptor agonist that acts on the melatonin MT1 and MT2 receptors in the brain. It was recently approved by the US FDA for the treatment of insomnia related to sleep onset. 18 In laboratory tests, the drug did not show potential for abuse or dependence, nor does it interact with neurotransmitter receptors most associated with these phenomena, thus it has the great advantage of being a nonscheduled drug. 18 Ramelteon has been shown to induce sleep initiation and maintenance in various animal models and in clinical trials. 21 In chronic insomnia, ramelteon decreases sleep latency and increases total sleep time and sleep efficiency, without causing hangover, addiction or withdrawal effects. 21 Ramelteon is thought to promote sleep by influencing homeostatic sleep signaling mediated by the suprachiasmatic nucleus. 21 Ramelteon has also been shown to be effective in treating insomnia in menopausal women. 19 Ramelteon has also been shown to be effective in treating insomnia in patients with generalized anxiety disorder (GAD). 3

Reasons for Side Effects

Ramelteon acts on melatonin receptors to induce sleep. Therefore, side effects such as drowsiness and fatigue may occur. Ramelteon is metabolized by the metabolic enzyme CYP3A4. Therefore, if CYP3A4 inhibitors are used concurrently, the blood concentration of ramelteon may increase, increasing the risk of side effects. 18

Common Side Effects

Drowsiness

The most common side effect of ramelteon is drowsiness. 18 Ramelteon acts on melatonin receptors to induce sleep. Therefore, side effects such as drowsiness and fatigue may occur. 18

Headache

Headache has also been reported as a side effect of ramelteon. 18

Dizziness

Dizziness has also been reported as a side effect of ramelteon. 18

Nausea

Nausea has also been reported as a side effect of ramelteon. 18

Indigestion

Indigestion has also been reported as a side effect of ramelteon. 18

Fatigue

Fatigue has also been reported as a side effect of ramelteon. 18

Depression

Depression has also been reported as a side effect of ramelteon. 18

Side Effects Management

Drowsiness

If you experience severe drowsiness after taking ramelteon, avoid driving or operating machinery. 18 You should also consider reviewing the timing of your ramelteon intake. 18

Headache

If you experience severe headaches after taking ramelteon, consult your doctor. 18

Dizziness

If you experience severe dizziness after taking ramelteon, consult your doctor. 18

Nausea

If you experience severe nausea after taking ramelteon, consult your doctor. 18

Indigestion

If you experience severe indigestion after taking ramelteon, consult your doctor. 18

Fatigue

If you experience severe fatigue after taking ramelteon, consult your doctor. 18

Depression

If you experience severe depression after taking ramelteon, consult your doctor. 18

Research Comparisons

Research Similarities

Many studies have shown that ramelteon induces sleep onset and maintenance. 18 21 19 3 Additionally, ramelteon has been shown to have no potential for abuse or dependence and relatively few side effects. 18 21

Research Differences

The effectiveness of ramelteon may vary depending on individual constitution and symptoms. For example, ramelteon has been shown to be effective in treating insomnia in menopausal women. 19 However, the effectiveness of ramelteon may be limited in other types of insomnia. 18

Things to Note About Applying to Real Life

Ramelteon has been approved by the FDA for the treatment of insomnia related to sleep onset. 18 However, ramelteon may not be effective for other types of insomnia. 18 Consult your doctor before taking ramelteon. 18 Also, avoid driving or operating machinery while taking ramelteon. 18

Current Research Limitations

There is still not much research on ramelteon. In particular, there is a lack of research on the long-term use of ramelteon. 18 21 There is also a need for research to investigate whether ramelteon is effective for other sleep disorders. 18

Future Research Directions

Research on the long-term use of ramelteon is needed. 18 21 There is also a need for research to investigate whether ramelteon is effective for other sleep disorders. 18 Research to elucidate the mechanism of ramelteon side effects is also important. 18

Conclusion

Ramelteon is a non-scheduled drug that has been approved by the FDA for the treatment of insomnia related to sleep onset. 18 Ramelteon has been shown to have no potential for abuse or dependence, and its side effects are relatively mild. 18 21 However, there is still not much research on ramelteon. Consult your doctor before taking ramelteon. 18

Literature analysis of 22 papers
Positive Content
21
Neutral Content
0
Negative Content
1
Article Type
2
2
3
11
22
2.

Alliance for Sleep Clinical Practice Guideline on Switching or Deprescribing Hypnotic Medications for Insomnia.

Author: WatsonNathaniel F, BencaRuth M, KrystalAndrew D, McCallWilliam V, NeubauerDavid N

Insomnia treatment

These guidelines provide evidence-based recommendations for deprescribing or transitioning between insomnia medications. Tapering is recommended for benzodiazepines and some Z-drugs, but not for other classes of insomnia medications.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Ramelteon for insomnia symptoms in a community sample of adults with generalized anxiety disorder: an open label study.

Author: GrossPaul K, NourseRosemary, WasserThomas E

Improved sleep
Reduced anxiety
Agitation
Daytime tiredness
Depression
Headache

Data from this 12-week open-label study suggests ramelteon is an effective and generally well tolerated treatment for insomnia symptoms in this community sample of adults with GAD.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Pharmacotherapy for insomnia.

Author: TariqSyed H, PulisettyShailaja

Insomnia treatment
Side effects

Hypnotics are commonly used to treat insomnia, particularly in older adults. While benzodiazepines, nonbenzodiazepines, and other agents such as trazodone, valerian, and melatonin are used, their effectiveness in older adults is often limited. Careful selection of agents, low starting doses, and close monitoring are crucial to minimize side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

The role of melatonin and melatonin agonists in counteracting antipsychotic-induced metabolic side effects: a systematic review.

Author: WangHee Ryung, WooYoung Sup, BahkWon-Myong

Improve lipid profiles
Lower blood pressure
Reduce weight gain

This systematic review investigated the potential of melatonin or melatonin agonists in attenuating metabolic side effects among psychiatric populations treated with atypical antipsychotics. The review of four trials (n = 138) showed that melatonin might lower blood pressure in bipolar disorder patients and improve lipid profiles, body composition, and weight gain in both schizophrenic and bipolar disorder patients. Ramelteon demonstrated efficacy in lowering total cholesterol.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

6.

Therapeutic uses of melatonin and melatonin derivatives: a patent review (2012 - 2014).

Author: RivaraSilvia, PalaDaniele, BediniAnnalida, SpadoniGilberto

Circadian rhythm re-synchronization
Sleep regulation
Limited bioavailability
Short half-life

This article discusses the various roles of melatonin, a neurohormone with antioxidant properties. Melatonin's impact on circadian rhythms, its potential therapeutic uses, and its pharmacokinetic challenges, including limited oral bioavailability and short half-life, are discussed.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood.

Author: SerfatyMarc Antony, OsborneDebbie, BuszewiczMarta J, BlizardRobert, RavenPeter W

Depression treatment
Sleep promotion
Early-morning waking
Major depressive disorder

This randomized, controlled trial evaluated the efficacy of exogenous melatonin in improving sleep and mood in patients with major depressive disorder (MDD) and early-morning waking. While both melatonin and placebo groups showed significant improvements, melatonin showed a trend towards better mood improvement without adverse side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Melatonin and melatonin-agonists for metabolic syndrome components in patients treated with antipsychotics: A systematic review and meta-analysis.

Author: MiolaAlessandro, FornaroMichele, SambataroFabio, SolmiMarco

Metabolic side effect attenuation

Antipsychotics, while effective for severe mental illness, have metabolic side effects. Evidence on the role of melatonin and melatonin-agonists in attenuating these metabolic abnormalities is conflicting.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

10.

Efficacy and safety of nonbenzodiazepine hypnotics for chronic insomnia in patients with bipolar disorder.

Author: SchafferCharles B, SchafferLinda C, MillerAmber R, HangEvelyn, NordahlThomas E

Insomnia treatment

Insomnia is a common problem in patients with bipolar disorder. Nonbenzodiazepine hypnotics (NBZHs) are often used to treat insomnia in these patients, but there is no specific FDA indication for their use.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

Pharmacological treatment of antipsychotic-induced dyslipidemia and hypertension.

Author: TseLurdes, ProcyshynRic M, FredriksonDiane H, BoydaHeidi N, HonerWilliam G, BarrAlasdair M

Metabolic abnormalities

Second-generation antipsychotics (SGAs) are associated with significant metabolic side effects, including dyslipidemia and hypertension. This review evaluated the effects of adjunct medications on lipid levels and blood pressure in patients taking SGAs. The review found that statins, conventional lipid-lowering agents, fluvoxamine, ramelteon, topiramate, valsartan, telmisartan, omega-3 fatty acids, metformin, and a combination of metformin-sibutramine seemed to have beneficial effects on lipid levels. Valsartan, telmisartan, and topiramate appeared to be effective for controlling increases in blood pressure.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Adverse Events Due to Insomnia Drugs Reported in a Regulatory Database and Online Patient Reviews: Comparative Study.

Author: BorchertJill S, WangBo, RamzanaliMuzaina, SteinAmy B, MalaiyandiLatha M, DineleyKirk E

Patient information
Postmarketing safety data
Reliability concerns

This abstract discusses the potential of online drug reviews as a source of postmarketing safety data but questions their reliability due to lack of professional review and verification.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis.

Author: De CrescenzoFranco, D'AlòGian Loreto, OstinelliEdoardo G, CiabattiniMarco, Di FrancoValeria, WatanabeNorio, KurtulmusAyse, TomlinsonAnneka, MitrovaZuzana, FotiFrancesca, Del GiovaneCinzia, QuestedDigby J, CowenPhil J, BarbuiCorrado, AmatoLaura, EfthimiouOrestis, CiprianiAndrea

Pharmacological treatments for insomnia

This study aimed to compare the effectiveness of different pharmacological treatments for insomnia in adults. While behavioral, cognitive, and pharmacological interventions are effective for insomnia, medications are more widely used due to resource limitations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

15.

Using Japanese big data to investigate novel factors and their high-risk combinations that affect vancomycin-induced nephrotoxicity.

Author: ImaiShungo, KadomuraShota, MiyaiTakayuki, KashiwagiHitoshi, SatoYuki, SugawaraMitsuru, TakekumaYoh

Ramelteon
Ward pharmacy
Piperacillin-tazobactam
VIN

Concomitant ramelteon use and ward pharmacy service may decrease the risk of vancomycin-induced nephrotoxicity (VIN), while concomitant use of piperacillin-tazobactam or piperacillin may increase the risk.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Pharmacotherapy Treatment Options for Insomnia: A Primer for Clinicians.

Author: AsnisGregory M, ThomasManju, HendersonMargaret A

Improved quality of life
Sleep-related complex behaviors

This abstract reviews the state of the art of pharmacotherapy for insomnia, including FDA-approved hypnotics and off-label options. It also discusses recent label changes regarding sleep-related complex behaviors and dose reductions for zolpidem preparations in women.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Practice GuidelineGuidelines and recommendations for the diagnosis and treatment of specific medical conditions in medical practice.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Jet lag: therapeutic use of melatonin and possible application of melatonin analogs.

Author: SrinivasanVenkataramanujan, SpenceD Warren, Pandi-PerumalSeithikurippu R, TrakhtIlya, CardinaliDaniel P

jet lag treatment
mood disorder treatment

Melatonin, a hormone that regulates the body's sleep-wake cycle, is effective for treating jet lag. Melatonin resets disturbed circadian rhythms and promotes sleep. Pre-departure melatonin administration can be used to prevent jet lag, but may cause unwanted side effects. New melatonin receptor agonists, such as ramelteon and agomelatine, may offer a better treatment option.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Ramelteon: a novel treatment for the treatment of insomnia.

Author: WurtmanRichard

Insomnia treatment
Non-addictive
Minor side effects

Ramelteon, a melatonin receptor agonist, is a non-scheduled drug approved for insomnia associated with sleep onset. There is a need for further research to compare its efficacy with physiologic doses of melatonin, especially for long-term use.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Ramelteon for the treatment of insomnia in menopausal women.

Author: DobkinRoseanne DeFronzo, MenzaMatthew, BienfaitKarina L, AllenLesley A, MarinHumberto, GaraMichael A

Menopausal insomnia treatment

Sleep disturbances are a common and troubling manifestation of menopause. While hormone replacement therapy (HRT) has historically been considered a first-line treatment for menopausal insomnia, many women are now seeking alternative treatments due to concerns about HRT's risks and side effects. This study evaluated the effects of ramelteon, a selective melatonin receptor agonist, for treating menopausal insomnia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Review of Safety and Efficacy of Sleep Medicines in Older Adults.

Author: SchroeckJennifer L, FordJames, ConwayErin L, KurtzhaltsKari E, GeeMegan E, VollmerKrista A, MergenhagenKari A

Improved sleep latency
Increased total sleep time
Dementia
Fractures
Residual daytime sedation
Serious injury
Somnolence

This review focuses on the safety and efficacy of medications used to treat insomnia in older adults. Cognitive behavioral therapy and sleep hygiene are considered initial therapy for insomnia. Benzodiazepines are discouraged in the geriatric population, especially for long-term use.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Drug Insight: the use of melatonergic agonists for the treatment of insomnia-focus on ramelteon.

Author: Pandi-PerumalSeithikurippu R, SrinivasanVenkataramanujan, PoeggelerBurkhard, HardelandRüdiger, CardinaliDaniel P

Insomnia treatment

This study reviewed the sleep-promoting effects of melatonin and ramelteon. While melatonin is available as a food supplement, ramelteon, a melatonin receptor agonist, has shown promise in clinical trials for chronic insomnia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

An Open-Labeled Trial of Ramelteon in Idiopathic Rapid Eye Movement Sleep Behavior Disorder.

Author: EsakiYuichi, KitajimaTsuyoshi, KoikeShigefumi, FujishiroHiroshige, IwataYasuyo, TsuchiyaAkiko, HiroseMarina, IwataNakao

RBD treatment

Ramelteon, a melatonin receptor agonist, shows potential as a treatment for rapid eye movement sleep behavior disorder.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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