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Bogdan Gusev
Bogdan Gusev

A to Z of Drugs: What You Need to Know About Prescription and OTC Medicines (PDF)

IBM Watson Micromedex Advanced Consumer Information provides comprehensive consumer information pertaining to a wide variety of drugs, such as a list of commonly used brand names, drug descriptions, warnings and precautions, and detailed information on the proper use of each drug.

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Link to the list of drugs preferred by MassHealth based on supplemental rebate agreements between MassHealth and drug manufacturers. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.

Link to the list of brand name drugs that MassHealth prefers over their generic equivalents because the net cost of the brand name drug adjusted for rebates is lower than the net cost of the generic equivalent. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.

Residual effects are dose-dependent and vary between hypnotics based on their pharmacokinetic profile. Of considerable concern are falls in the elderly leading to hip fractures, head injuries, and other significant morbidity and mortality. Furthermore, the effect of Z-drugs on next-day human performance and driving impairment has held sharp focus in the public health sphere as well as in forensic and legal circles. In March 2007, the US FDA released a list of 13 drugs for which stronger labeling was recommended regarding the potential risk of complex sleep-related behaviors [12]. These behaviors, discussed further below, involved parasomnias such as sleep-eating and sleep-driving. Z-drugs were included in the FDA warning list, and this was soon followed by warnings from other drug regulatory agencies across the world, including the Australian Therapeutic Goods Administration [13]. Since then, several epidemiological studies have attempted to quantify the risk of bizarre behaviors from hypnotic drugs and any differential rates of incidence between them.

Following publicity from the FDA and other regulatory authorities in 2007, Z-drug adverse reaction reporting increased due to health professional and consumer awareness of a potential relationship. Since 2007, adverse drug reporting systems in Australia showed higher rates of reports associating zolpidem and various adverse events such as parasomnia, amnesia, hallucinations, and suicidality. However, retrospective analysis suggests that zolpidem was associated with an increased risk of these adverse events compared with other drugs even prior to the media publicity in 2007 [14].

Many of these studies do not simulate real life scenarios in which patients are prescribed Z-drugs on a long-term basis, leading us to question whether chronic use may lead to tolerance of performance-impairing effects. There appears to be some tolerance to memory and psychomotor impairment from benzodiazepines, such as triazolam [26]. There is emerging evidence that this type of tolerance may not occur with Z-drugs. In a unique study where healthy volunteers took extended-release (ER) zolpidem nightly over a 3- to 4-week period, there was significant memory and performance impairment during nocturnal awakening, which did not improve with chronic dosing [27]. Similarly, Frey et al. showed that 5 mg zolpidem caused significant impairment of cognitive function (working memory and mathematical calculations) in both young adults (mean age 22 years) and older adults (mean age 67 years) during nocturnal awakening [28]. Nocturnal awakening may occur in patients with insomnia for several reasons, and middle-of-the-night impairment due to Z-drugs raises patient safety concerns with regard to falls, amnesia, and decision-making capacity.

Balance tests in healthy young volunteers suggest that both zolpidem and zopiclone have a profound dose-dependent effect on postural sway and body balance in the first few hours after intake [17, 18, 45]. This effect correlates with peak plasma levels of these Z-drugs but may persist into the morning. Psychomotor effects are exacerbated in elderly Z-drug users due to altered pharmacokinetics and increased sensitivity to peak drug action [46]. Although most people will be asleep in the first few hours after Z-drug ingestion, many elderly users may awaken and mobilize, predisposing them to imbalance and falls. Zolpidem, at a dose of 5 mg, induced middle-of-the-night tandem walk failures on a 10-cm-wide beam in older subjects compared with younger ones and controls; in this study, subjects were awakened 2 h after zolpidem administration [28]. The failure of tandem walking occurred in 3 out of 13 younger subjects only in the first few minutes after awakening. However, persistent impairment was seen in older subjects with 2 out of 12 failing the tandem walk 30 min after awakening. This is of considerable concern as zolpidem induces imbalance and ataxia at the reduced dose of 5 mg, recommended for elderly patients.

A Swedish study examined zolpidem and zopiclone levels in impaired drivers and in post-mortem blood samples from deceased drivers; it showed elevated levels of both Z-drugs, suggestive of supratherapeutic use [74]. Caution should be used when interpreting these levels, as there were considerable variation, overlap with therapeutic concentrations, and potential for drug interactions. Gustavsen et al. demonstrated a clear dose relationship between increasing zopiclone levels and the degree of driving impairment, similar to that for alcohol [75]. The proportion of impaired drivers was roughly equal when the BAC exceeded 0.1 % and zopiclone concentrations were greater than 130 ng/mL. No such relationship was demonstrated for zolpidem in the same study. There are little data on zaleplon levels and driving impairment likely due to low prescription rates and a short detection window.

In Norway, legislators have sought to set impairment limits for illicit substances and prescription medications comparable to those set for alcohol. Norway is the first country in the world to set legally binding limits for drugs other than alcohol [78]. Since February 2012, 13 substances including benzodiazepines and 2 Z-drugs have legal limits with graded sanctions; the set limits are not intended to apply to drivers with a valid prescription for the detected medication [79]. Driving impairment thresholds for zolpidem and zopiclone in Norway are shown in Table 2 [58, 73, 74, 80]. Some authors have suggested that per se limits for illicit substances and psychoactive medications are impractical and likely to be ineffective due to inter-individual differences in drug tolerance, poly-drug use, and poor correlation between drug concentration and impairment [81]. It is suggested that field sobriety testing and confirmation of impairment, coupled with valid prescriptions for medication, would be more reliable and objective grounds for a legislative framework.

Traditional therapy for insomnia has predominantly involved the use of benzodiazepines for several decades. Since the 1980s, development of non-benzodiazepine drugs for the management of insomnia has been driven by the significant adverse effect profile of the former group of drugs. The Z-drugs have unique advantages over benzodiazepines both in their pharmacodynamic and pharmacokinetic properties. Z-drugs have significant hypnotic effects by reducing sleep latency and improving sleep quality, though their ability to prolong total sleep time is debatable [4]. Currently, there are three Food and Drug Administration (FDA)-approved, commercially available, non-benzodiazepine drugs in the USA for the treatment of insomnia: zaleplon, zolpidem, and eszopiclone (the active enantiomer of zopiclone) [5].

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Zopiclone is a cyclopyrrolone drug with a chemical structure unrelated to zolpidem, benzodiazepines, or other CNS depressants; it has similar pharmacodynamic and pharmacokinetic properties to zolpidem. It is available as a racemic mixture of two enantiomers one of which is marketed in the USA, the (S)-enantiomer, eszopiclone. Zopiclone shows preferential agonist activity at the α1 subunit of the GABAA receptor and its duration of action is the longest of the Z-drugs, comparable with some short-acting benzodiazepines. Hence, zopiclone is useful in both induction and maintenance of sleep. Eszopiclone differs from its racemic mixture in that it has greater efficacy at the α2 and α3 subunits. The addition of the R-enantiomer in racemic zopiclone may augment efficacy at the α1 subunit and potentially lead to increased sedation and residual effects [14].

Hair analysis may be useful in confirming prior exposure to Z-drugs, such as in cases of chronic use or drug-facilitated sexual assault. It can potentially complement tests done on blood and urine, though in some scenarios hair may be the only matrix available. Hair as a biological matrix has several advantages including ease of sampling, storage, and transportation [64]. In general, detection of Z-drugs in hair is difficult due to the low level of uptake into hair. The most developed and sensitive method to detect Z-drugs in hair is liquid chromatography coupled with tandem mass spectroscopy [52]. Depending upon the dose and frequency of Z-drug use, length of hair sampling, and analytical technique utilized, exposure may be confirmed by hair testing weeks, if not months, later. Hair testing must be interpreted appropriately based on limits of detection, inability to determine dose ingested, and potential for poor drug uptake into hair at very low doses [65].

Benzodiazepines (BZDs) and Z-drugs have high potential for developing frequent adverse drug events in older adults (e.g., psychomotor sedation, drug-related dementia, deliria, drug dependence, etc.). Knowledge of the prevalence and patterns of the use of BZDs/Z-drugs in vulnerable older patients is important in order to prevent and reduce the burden caused by their drug-related complications. Our study focused on international comparisons of the prevalence, country-specific prescribing patterns and risk factors of regular BZD/Z-drug use in nursing home (NH) residents.


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