- |||||||||| Wellbutrin XL (bupropion hydrochloride ER) / Bausch Health, GSK
[VIRTUAL] Suspected Clitoral Priapism and Persistent Sexual Arousal in a Female Psychiatric Inpatient With Recent Dose Increase of Quetiapine: A Case Report () - May 2, 2021 - Abstract #APA2021APA_652;
OBGYN was consulted and reported a normal gyn exam.Persistent arousal and feeling on the verge of orgasm gradually declined with immed.resolution of “swollen clitoris.”By HD11, pt reported cessation of sexual sxs.By HD12 plan for ECT and ongoing care was solidified and pt was d/c’d at her request with all her chronic meds but quetiapine and topiramate.D:This case encapsulates elements of all 3 syndromes described above, with presumed etiology of uptitration of quetiapine.Her sxs gradually resolved upon discontinuation of this agent.Clitoral priapism in pts on antipsychotics has been linked to effects on a1 and a2 adrenergic, H1, and dopaminergic receptors.Quetiapine is of low to intermed. strength as an a1 blocker amongst commonly used antipsychotics.Quetiapine also is an antagonist at D2 and 5-HT2 Rs.It blocks 5HT1A, 5- HT2, D1, D2, H1, A1 and A2 Rs.Polypharm.is also predisposing to adverse effects of any kind.Human sexuality is contingent upon many biological, psychological, social, and cultural factors.It is nec that members of the care team are aware of the potential for adverse sexual effects and create a safe space where pts can report all concerns.
- |||||||||| zolpidem ER / Generic mfg., eszopiclone / Generic mfg.
Trial completion date, Trial primary completion date: CIS2: Safety and Efficacy of Chronic Hypnotic Use 2 (clinicaltrials.gov) - Apr 23, 2021
P4, N=120, Recruiting,
Providing guidance to ensure proper compliance is thought to be the best way to mitigate withdrawal symptoms. Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Jul 2021 --> Jul 2023
- |||||||||| eszopiclone / Generic mfg., zaleplon / Generic mfg.
Journal: Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death. (Pubmed Central) - Apr 22, 2021
Therefore, to protect public health, regulatory actions were taken, including adding a Boxed Warning, a Contraindication in patients who have experienced a prior episode of a CSB with a Z-drug, and updating the existing Warnings and Precautions. An FDA Drug Safety Communication was also disseminated to alert healthcare professionals and the public of this potential risk.
- |||||||||| Belsomra (suvorexant) / Merck (MSD)
[VIRTUAL] Cost-effectiveness of suvorexant for the treatment of adults with primary chronic insomnia () - Apr 17, 2021 - Abstract #AMCP2021AMCP_350;
Using the linear relationship between ISI and EQ-5D scores, the results show that suvorexant may be less effective and more costly than treatment comparators. Given the increasing number of pharmacological interventions for insomnia, additional research is warranted in the cost-effectiveness of current and future agents in this therapeutic area.
- |||||||||| Belsomra (suvorexant) / Merck (MSD)
[VIRTUAL] BUDGET IMPACT ANALYSIS OF THE FIRST FDA-AUTHORIZED, NON-DRUG, PRESCRIPTION DIGITAL THERAPEUTIC FOR THE TREATMENT OF CHRONIC INSOMNIA () - Apr 11, 2021 - Abstract #AMCP2021AMCP_99;
Comparators included traditional face-toface cognitive behavioral therapy for insomnia (CBT-I) and branded (i.e., Belsomra [suvorexant], Lunesta [eszopiclone], Ambien [zolpidem tartrate], and Rozerem [ramelteon]) and generic (i.e., eszopiclone, zolpidem tartrate, and benzodiazepines) prescription insomnia medications (PIMs). When a PDT for treatment of insomnia is used, estimated total costs, PMPM costs, and PPPM costs were lower with the PDT compared to a world without the PDT.
- |||||||||| Belsomra (suvorexant) / Merck (MSD)
[VIRTUAL] COST-EFFECTIVENESS ANALYSIS OF THE FIRST FDA-AUTHORIZED PRESCRIPTION DIGITAL THERAPEUTIC (PDT) FOR THE TREATMENT OF CHRONIC INSOMNIA () - Apr 11, 2021 - Abstract #AMCP2021AMCP_98;
Comparators included face-to-face cognitive behavioral therapy for insomnia (CBT-I) and branded (i.e., Belsomra [suvorexant], Lunesta [eszopiclone], Ambien [zolpidem tartrate], and Rozerem [ramelteon]) and generic (i.e., eszopiclone, zolpidem tartrate, and benzodiazepines) prescription insomnia medications (PIMs). In this cost effectiveness analysis, the PDT was cost-effective vs. generic PIMs, and economically dominant relative to branded PIMs and CBT-I.
- |||||||||| trazodone ER / Generic mfg.
[VIRTUAL] Pharmacologic Management of Insomnia with Sleep Apnea () - Apr 4, 2021 - Abstract #CPNP2021CPNP_124;
This session is designed to provide the evidence around the treatment of insomnia in patients with comorbid sleep apnea. Learning Objectives: Recommend strategies to improve adherence to continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea and co-morbid insomnia.Evaluate the risks and/or benefits of sedative-hypnotics for treatment of insomnia in patients with co-morbid obstructive sleep apnea.Create a pharmacologic treatment plan for management of insomnia in a patient with co-morbid obstructive sleep apnea who has tried and failed non-pharmacologic interventions.
- |||||||||| zaleplon / Generic mfg.
[VIRTUAL] Evaluation of Z-Drug Use in Adult Patients at a Federally Qualified Health Center () - Apr 4, 2021 - Abstract #CPNP2021CPNP_91;
Adult outpatients prescribed z-drugs (zolpidem, zaleplon, eszopiclone) from in-clinic providers between the dates January 1, 2020 and December 31, 2020 will be identified through retrospective chart review. Outcomes: Population demographics and dosing information will be reported using descriptive statistics.
- |||||||||| venlafaxine / Generic mfg., acetazolamide / Generic mfg., eszopiclone / Generic mfg.
Enrollment open, Trial initiation date: RESCUE-Combo: Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea (clinicaltrials.gov) - Mar 12, 2021
P2, N=20, Recruiting,
Outcomes: Population demographics and dosing information will be reported using descriptive statistics. Not yet recruiting --> Recruiting | Initiation date: Dec 2020 --> Jan 2020
- |||||||||| eszopiclone / Generic mfg.
Clinical, Journal: Associations of Benzodiazepine With Adverse Prognosis in Heart Failure Patients With Insomnia. (Pubmed Central) - Mar 9, 2021
A total of 826 patients who had been hospitalized for HF and were being treated for insomnia with either benzodiazepines or Z-drugs (zolpidem, zopiclone, or eszopiclone), were enrolled and divided on the basis of their hypnotics: benzodiazepine group (n=488 [59.1%]) and Z group (n=338 [40.9%])...Furthermore, rehospitalization for HF was higher in the benzodiazepine group after propensity score matching (log-rank P=0.036). Conclusions Benzodiazepine is associated with higher risk of rehospitalization for HF compared with Z-drugs in patients with HF.
- |||||||||| eszopiclone / Generic mfg., trazodone ER / Generic mfg.
Enrollment open: NAP: National Adaptive Trial for PTSD Related Insomnia (clinicaltrials.gov) - Mar 3, 2021
P3, N=1224, Recruiting,
Conclusions Benzodiazepine is associated with higher risk of rehospitalization for HF compared with Z-drugs in patients with HF. Not yet recruiting --> Recruiting
- |||||||||| Nuplazid (pimavanserin) / Acadia Pharma
Clinical, Review, Journal: Novel pharmacological treatments for generalized anxiety disorder: Pediatric considerations. (Pubmed Central) - Jan 1, 2021
Notwithstanding numerous challenges, some of these agents represent potential candidate drugs for pediatric GAD. Further treatment development studies of agomelatine, eszopiclone, pimavanserin and riluzole for pediatric GAD also have the prospect of informing the understanding of GABAergic and glutamatergic function across development.
- |||||||||| Vivelle (estradiol transdermal system) / Sanofi, Hisamitsu, Novartis
Journal: Drugs for menopausal symptoms. (Pubmed Central) - Dec 30, 2020
Further treatment development studies of agomelatine, eszopiclone, pimavanserin and riluzole for pediatric GAD also have the prospect of informing the understanding of GABAergic and glutamatergic function across development. No abstract available
- |||||||||| eszopiclone / Generic mfg.
Clinical, Journal: Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey. (Pubmed Central) - Dec 18, 2020
Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.
- |||||||||| eszopiclone / Generic mfg., zaleplon / Generic mfg.
Review, Journal: Z-drugs and Falls: A Focused Review of the Literature. (Pubmed Central) - Dec 15, 2020
Eight trials examined falls as a primary outcome in non-elderly (n=3) and elderly (n=5) patients in different settings, mostly in an inpatient setting (nursing facility or acute care hospital). Exposure to Z-drugs, especially zolpidem, should be evaluated and counseled on continuously as these medications put patients at an increased risk for falls and other complications.
- |||||||||| Silenor (doxepin) / Currax, Dayvigo (lemborexant) / Eisai
Journal: Lemborexant (Dayvigo) for insomnia. (Pubmed Central) - Sep 16, 2020
More frequent patient follow-up and a more comprehensive evaluation of the patient's sleep quality may identify potential treatment failures earlier on. No abstract available
- |||||||||| Silenor (doxepin) / Currax
[VIRTUAL] A network meta-analysis of the efficacy of hypnotics for insomnia in older adults (Poster Networking Lounge) - Aug 16, 2020 - Abstract #ESRS2020ESRS_106;
Considering the potential adverse effects of BZDs and non-BZDs, low-dose doxepin may be the optimal pharmacotherapy for improving sleep duration and SE. Future RCTs investigating the treatment effects of hypnotics, particularly low-dose doxepin, on insomnia in older adults are warranted.
- |||||||||| eszopiclone / Generic mfg., trazodone ER / Generic mfg.
Trial completion date, Trial primary completion date: NAP: National Adaptive Trial for PTSD Related Insomnia (clinicaltrials.gov) - Aug 8, 2020
P3, N=1224, Not yet recruiting,
Future RCTs investigating the treatment effects of hypnotics, particularly low-dose doxepin, on insomnia in older adults are warranted. Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
- |||||||||| eszopiclone / Generic mfg.
[VIRTUAL] The Impact of Hypnotic Use on Cognitive Function in Migraine Patients () - Jul 15, 2020 - Abstract #AHS2020AHS_273;
The etiology of this remains unclear, however the difference appears to have some relationship to chronicity of migraines rather than reported migraine disability. History of hypnotic sleep aid use was associated with significantly lower cognitive scores in migraine patients.
- |||||||||| Ambien CR (zolpidem ER) / Generic mfg., eszopiclone / Generic mfg.
[VIRTUAL] REBOUND INSOMNIA DURING DISCONTINUATION OF CHRONIC HYPNOTIC USE () - Jun 29, 2020 - Abstract #Sleep2020SLEEP_186;
We reported in a companion abstract those with insomnia and hyperarousal, defined by MSLT, are those with difficulty discontinuing hypnotic use and as shown here slept poorly on the last study night. Support: NIDA, grant#: R01DA038177 awarded to Dr.
- |||||||||| eszopiclone / Generic mfg.
Clinical, Review, Journal: Pharmacologic Treatments for Sleep Disorders in Children: A Systematic Review. (Pubmed Central) - Jun 18, 2020
Single randomized controlled trials of zolpidem and eszopiclone in children with attention-deficit/hyperactivity disorder (ADHD) showed no improvement in sleep or ADHD ratings...These findings show that melatonin was useful in improving some sleep outcomes in the short term, particularly those with comorbid ASD and neurodevelopmental disorders. Other drugs and outcomes are inadequately studied.
- |||||||||| Ambien CR (zolpidem ER) / Generic mfg., eszopiclone / Generic mfg.
[VIRTUAL] Sleep and Hyperarousal: Inability to Discontinue Chronic Hypnotic Use () - Jun 13, 2020 - Abstract #CPDD2020CPDD_471;
High MSLTs were previously associated with dose escalation in a chronic zolpidem use study. These emerging data would suggest high MSLT may also be predictive of difficulty discontinuing hypnotic use.
- |||||||||| eszopiclone / Generic mfg., trazodone ER / Generic mfg.
Trial completion date, Trial primary completion date: NAP: National Adaptive Trial for PTSD Related Insomnia (clinicaltrials.gov) - May 7, 2020
P3, N=1224, Not yet recruiting,
These emerging data would suggest high MSLT may also be predictive of difficulty discontinuing hypnotic use. Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023
- |||||||||| eszopiclone / Generic mfg.
Targeting Sleep Oscillations to Improve Memory in Schizophrenia () - Apr 17, 2020 - Abstract #SOBP2020SOBP_647;
Interventions to improve sleep-dependent memory consolidation in schizophrenia must not only increase spindles, but also enhance sleep oscillatory dynamics and restore function at the network level. Funding Source: NHLBI T32HL007901-17 ; R01 MH67720 ; K24MH099421; K01MH114012; 1S10RR023401, 1S10RR019307, 1S10RR023043; NCRR UL1TR001102-01 to Harvard Clinical and Translational Science Center.
- |||||||||| eszopiclone / Generic mfg.
Journal, Adverse events: Reintroduction of quazepam: an update on comparative hypnotic and adverse effects. (Pubmed Central) - Mar 22, 2020
Pharmacological treatments for insomnia include benzodiazepines (BZs) and the non-BZ 'Z-drugs' (zolpidem, zaleplon, eszopiclone, zopiclone), which are amongst the most widely prescribed medications...These features likely drive the decreased rate of adverse events seen clinically with quazepam, such as tolerance, rebound insomnia and amnesic behaviours, compared with other BZ. Given the recent reintroduction of quazepam as a pharmacotherapeutic option, and the lack of head-to-head comparative trials against newer agents, the purpose of this review is to provide an update on distinguishing features of quazepam with regard to its pharmacology, pharmacokinetics, sleep efficacy and potential adverse effects compared to other agents used for insomnia.
- |||||||||| eszopiclone / Generic mfg.
Trial completion: AAPI: Auricular Acupuncture for Primary Insomnia (clinicaltrials.gov) - Feb 17, 2020
P=N/A, N=288, Completed,
We speculate that in such patients a greater proportion of the adherence-variance may be explained by physiological (i.e. Recruiting --> Completed
- |||||||||| eszopiclone / Generic mfg., trazodone ER / Generic mfg.
Trial completion date, Trial primary completion date: NAP: National Adaptive Trial for PTSD Related Insomnia (clinicaltrials.gov) - Jan 21, 2020
P3, N=1224, Not yet recruiting,
This effect of improvement of sleep disturbance on GI symptoms may be related to pain modification. Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: May 2023 --> Sep 2023
- |||||||||| eszopiclone / Generic mfg.
Review, Journal: Treatment Options for Insomnia in Schizophrenia: A Systematic Review. (Pubmed Central) - Dec 24, 2019
Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: May 2023 --> Sep 2023 Despite a very limited number of specific studies on this matter, all 4 studies have shown good benefit/risk ratios and reviewed options-melatonin, paliperidone, and eszopiclone-might represent valid options for residual insomnia in schizophrenia.
- |||||||||| eszopiclone / Generic mfg.
Enrollment change, Trial completion date, Trial termination: Sleep Effectiveness and Insulin and Glucose Homeostasis (clinicaltrials.gov) - Dec 19, 2019
P1, N=20, Terminated,
Despite a very limited number of specific studies on this matter, all 4 studies have shown good benefit/risk ratios and reviewed options-melatonin, paliperidone, and eszopiclone-might represent valid options for residual insomnia in schizophrenia. N=48 --> 20 | Trial completion date: Dec 2020 --> Dec 2019 | Active, not recruiting --> Terminated
- |||||||||| Atarax (hydroxyzine hydrochloride) / Alliance, mirtazapine / Generic Mfg.
Clinical, Review, Journal: Practitioner Review: Treatment of chronic insomnia in children and adolescents with neurodevelopmental disabilities. (Pubmed Central) - Oct 20, 2019
Here, we provided a tentative guide for the use of drugs for insomnia in children with NDDs. Well-controlled studies employing both objective polysomnography and subjective sleep measures are needed to determine the efficacy, effectiveness, and safety of the currently prescribed pediatric sleep medicines in children with NDDs.
- |||||||||| eszopiclone / Generic mfg.
Trial completion date, Trial primary completion date: PRECEPT-D: Effectiveness of Combining Behavioral and Pharmacologic Therapy for Complex Insomnia in Veterans With PTSD (clinicaltrials.gov) - Oct 2, 2019
P4, N=52, Not yet recruiting,
Well-controlled studies employing both objective polysomnography and subjective sleep measures are needed to determine the efficacy, effectiveness, and safety of the currently prescribed pediatric sleep medicines in children with NDDs. Trial completion date: Sep 2023 --> Mar 2024 | Trial primary completion date: Jul 2023 --> Oct 2023
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