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Digital Therapeutics for Sleep and Mental Health
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Peter Hames, Christopher B. Miller
In sum, insomnia is a widespread problem searching for novel solutions to address the treatment gap between access to first-line treatments, as recommended by clinical guidelines, and the reality of clinical practice (e.g., pharmacological therapy). Despite their widespread use, there are notable limitations and risks in the use of pharmacological treatments, such as Z-drugs, for insomnia. Moreover, there is a need to overcome a key limiting factor for access to psychological therapy: a scarcity of trained mental health practitioners to serve the millions of people who need help as today; it is estimated that there are 30 psychologists per 100,000 people.9
Sedative and Hypnotic Drugs
Published in Sahab Uddin, Rashid Mamunur, Advances in Neuropharmacology, 2020
Arup Kumar Misra, Pramod Kumar Sharma
Zolpidem, eszopiclone, and zaleplon are collectively known as “Z-drugs” though they have the same mechanism of action as benzodiazepines but they are structurally unrelated (Gregory, 2016). Ramelteon and tasimelteon are the melatonin receptor agonists which are approved by US FDA as newer hypnotics indicated for non-24-h sleep–wake disorders (Laudon, 2014). An orexin receptor antagonist, suvorexant was introduced in the market in August 2014 and is indicated to improve sleep duration. Buspirone is a slow-onset anxiolytic agent differing from the conventional sedative–hypnotics in their mechanism of action (Mendelson, 1990).
Safer Prescribing: The Threat and Challenge of Caring for People with Chronic Pain
Published in James Matheson, John Patterson, Laura Neilson, Tackling Causes and Consequences of Health Inequalities, 2020
Clarissa Hemmingsen, James Matheson
Over the last 5 years, spending on hypnotics like zopiclone and zolpidem has decreased but the rates of prescription have remained similar [39]. The number of deaths involving zopiclone and zolpidem continue to rise, from 96 in 2016 to 127 in 2017 and, as with benzodiazepines, in 8 out of 10 deaths, mixing with other drugs was implicated [30]. Higher levels of anxiolytic and hypnotic medications have long been understood to be associated with areas of deprivation [40]. In the UK there has been a widespread perception among doctors that z-drugs are safer than benzodiazepines though they share similar risks of respiratory effects including respiratory depression, especially when taken with alcohol [41]; addiction, with evidence of withdrawal symptoms after 3 weeks, less than its licensed duration of treatment [42], tolerance and misuse potential [43]. There is a high risk of rebound insomnia when stopped after longer-term use. Pharmacologically, zopiclone is known for its low index of fatal toxicity [44], as low or lower than benzodiazepines [45,46]. One American review found the mortality risk associated with taking a hypnotic to be equivalent to smoking a pack of cigarettes a day [47]. In the US the Food and Drug Administration has placed a high-risk warning on the z-drugs after multiple reports of people being injured or killed by unconscious behaviours whilst on the medications including through activities such as cooking, driving and shooting themselves [48].
Understanding the unmet needs in insomnia treatment: a systematic literature review of real-world evidence
Published in International Journal of Neuroscience, 2023
Renee Campbell, Isabelle Chabot, Ben Rousseau, Daisy Bridge, Gillian Nicol, Genevieve Meier
Concerns over the side-effect profile and perceived lack of efficacy associated with currently licensed insomnia treatments (including benzodiazepines and Z-drugs) result in substantial off-label use of other treatments, despite a lack of clinical evidence of risk/benefit ratios and evidence of serious adverse events [18–23,25,30,38,40,42,61,63,91,96–108]. Specifically, antidepressants such as trazodone were often prescribed for treating insomnia, despite a lack of evidence for their efficacy and evidence they can lead to anticholinergic events and orthostatic hypotension [14]. Moreover, concerns over the highly addictive properties of benzodiazepines prevent health care professionals prescribing this approved treatment for insomnia [11]. Patients with insomnia who are prescribed benzodiazepines, or Z-drugs, often develop a tolerance leading to the use of higher than approved doses and a longer treatment duration to achieve the desired effect. This can result in dependence and subsequent exacerbation of adverse events (e.g. impaired motor coordination). Therefore, effective and approved long-term treatments for insomnia are needed, which are considered by health care professionals to have an acceptable safety profile compared to off-label treatment options. Specifically, the introduction of a therapy without the risk of dependence would allow its prolonged use to ameliorate symptoms in patients with chronic insomnia.
A primer on sleeping, dreaming, and psychoactive agents
Published in Journal of Social Work Practice in the Addictions, 2023
Cyclopyrrolones, otherwise known as Z-drugs, while pharmacologically distinct from benzodiazepines, still bind to GABA receptors. The most prominent feature of Z-drugs is that they decrease sleep latency and increase the duration of sleep. The duration of stage one sleep is shortened, while the time spent in stage two sleep is typically increased. In most studies, stage three sleep tended to be increased, but no change and actual decreases was observed in clinical trials. The effect of zopiclone on stage three sleep differed from that of traditional benzodiazepines, which suppress slow-wave sleep. While the onset of REM sleep was delayed, this drug group does not appear to reduce the total duration of REM sleep, according to pharmaceutical agency sponsored studies (Nu-Pharm, 2009; Sanofi-Aventis, 2018). However, in 2014 Health Canada placed a recommended dosage limitation on the use of zopiclone due to the adverse behaviors its users were experiencing, including impairments lasting for up to two days. Amnesia can result from using this drug, as highlighted by reports of people getting out of bed, while not fully awake after taking cyclopyrrolones and unknowingly engaging in activities, with no memory of the action the next day (Sanofi-Aventis, 2018).
Challenges and opportunities in insomnia disorder
Published in International Journal of Neuroscience, 2021
Meaghan Roach, Timothy Juday, Rifat Tuly, Jacquelyn W. Chou, Anupam B. Jena, Paul P. Doghramji
Commonly used pharmacotherapies that are US Food and Drug Administration (FDA) approved for insomnia disorder have important drawbacks. Benzodiazepines (BZDs) like temazapam, triazolam, and estazolam, and non-benzodiazepines with benzodiazepine-like effects (also called ‘Z-drugs’), such as zolpidem, eszopiclone, or zaleplon, can be used as first-line pharmacotherapy. Despite demonstrated efficacy with increasing objective measures such as total sleep duration, long-term use of BZDs is discouraged due to the potential for tolerance and dependence [12]. In addition, BZDs have been associated with memory impairment, depression, and cognitive impairment [46]. While Z-drugs are associated with some of these same negative effects, they often have a faster onset of action and more rapid clearance, which can lessen the severity of these adverse effects [47].