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Addressing Hypnotic medicines use in primary care

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1 Addressing Hypnotic medicines use in primary care
National Prescribing Service Presented by Joyce McSwan Accredited Consultant Pharmacist

2 Established in 1998, NPS enables people to make better decisions about medicines and medical tests, leading to better health and economic outcomes. Originally started in SA, it is available to help health professionals keep up to date with the latest evidence and provide individuals with the tools and knowledge to make better decisions. The NPS Professional suite includes information and tools developed for primary and allied healthcare professionals, one of which is the information that will be this brief presentation on addressing hypnotic medicines use in primary care. The aim of this presentation is to highlight some of the key messages from the NPS on the use of hypnotic medicines. Information provided by NPS is evidence based, however please bear in mind that all decisions of drug therapy and non-drug therapy is totally dependent on your knowledge gained over years of experience. Thus, there is no black or white, similar to the fact that there are no two same person, but a grey area of possible options depending on each case.

3 Insomnia in Primary Care
95% Between 2006 and 2008, 80% of GP encounters for sleep disorders were for insomnia. Hypnotic medicines were prescribed for 95 per 100 insomnia problems encountered in general practice. 80%

4 What Insomnia is not....

5 Difficulty falling asleep Difficulty staying asleep OR
3 Ds of Insomnia Difficulty falling asleep Difficulty staying asleep OR Day time distress (associated with non refreshing sleep)

6 1. Identify and manage contributing factors first
Medications Behavioural Substance Use Insomnia Complaint Circadian rhythm disorder Psychiatric Disorder Situational Medications Antiepileptics – phenytoin, lamotrigine Beta blockers Beta 2 agonists – bronchodilators CNS stimulants Diuretics Levodopa SSRIs Substance Use Alcohol, caffeine, nicotine, energy drinks Circadian rhythm disorder Jet lag, shift work Situational Grief, stress Medical condition Chronic pain, HF, COPD, GORD, Urinary incontinence, physical and mental disabilities Primary sleep disorder Periodic limb disorders, Restless leg syndrome, sleep apnoea Environmental Light, noise Psychiatric disorder Anxiety, dementia, depression Behavioural Daytime nap, heavy meals, lack of exercise Environmental Primary sleep disorder Medical condition

7 1a. Offer non-drug therapies for insomnia
Benefits: Persistent sleep improvements after therapy Reduced potential for harms No risk of drug dependence NPS recommends using behavioural and cognitive therapies as initial treatment for insomnia. The benefits of using non-drug therapy as compared with hypnotic agents are: Persistent sleep improves within 2 months of therapy Reduced potential for harms No risk of drug dependence

8 Most evidence - Behavioural and cognitive therapies In 4-8 weeks,
Fall asleep faster (23 mins vs 14 mins earlier) Reduce their time awake (30 mins after sleep onset) Improvement up to 2 years > 55 yo Hypnotic medicines do not provide this long- term benefit Behavioural and cognitive therapies have the most evidence for effectiveness in treatment insomnia. Using a combination of B and Co therapies (over a period of 4-8 wks) along with good sleep practices, patients fall asleep faster (23 mins earlier than placebo for B&C therapy as compared to hypnotic medicines 14 minutes earlier) and reduce their time awake after sleep onset by up to 30 minutes. These benefits are maintained for up to 2 years and these therapies benefit adults > 55 yo.

9 Advice on good sleep practices
Cognitive Therapy Stimulus Control Sleep restriction Relaxation therapy The non-drug therapies recommended by the NPS are as follows. In the NPS News 67 in box 1 you will see that it details the specific therapy to the different components of insomnia that it will assist with. Advice alone does not appear to be sufficient for chronic insomnia (insomnia that has been present for > 4 weeks). However, combining advice on good sleep practices with one other therapy is recommended. Lifestyle habits and environment not conducive to sleep Advice on good sleep practices Practical tips on how to modify diet, exercise patterns, substance use, sleep–wake schedule, daytime napping, and sleep environment. Negative thoughts or unrealistic expectations about sleep and the consequences of sleep loss Cognitive therapy Techniques that replace distorted beliefs and attitudes with positive ones (e.g. reassure that < 8 hours sleep a night is not necessarily detrimental). Refer to pack for list of CBT trained psychologists in Mackay region. Learned association between going to bed and being unable to sleep Stimulus control Go to bed only when tired (and only use the bed for sleep or sex), get out of bed if not asleep within a perceived 20 minutes (do not watch the clock); repeat each night until a stable sleep–wake schedule is established. Poor sleep drive results in broken sleep or excessive time spent in bed awake Sleep restriction Restrict time in bed to actual sleep duration and have a set wake-up time; increase gradually as total sleep duration improves, and until the target sleep time is reached (not < 5 hours). Unable to mentally and/or physically wind down each night Relaxation techniques Progressively focus on and relax each muscle group; taking deep breaths, relax and imagine something pleasant for as long as possible.

10 2. Hypnotic Medicines Length of action Drugs Recommended Dosage
PBS eligibility Very short T ½ < 6hrs Zolpidem Zolpidem CR Zopiclone 5-10mg hs 6.25mg-12.5mg hs 3.75mg-7.5mg before bedtime Non-PBS RPBS-R Short T ½ 6-12 hrs Temazepam Oxazepam 10mg before hs 7.5-30mg before hs PBS/PBS-A Consider short acting benzodiazepine or non-benzodiazepines (like zolpidem and zoplicone or what we call the ‘Z’ drugs) only if: Short term relief is needed and Non-drug therapies cannot be implemented in acute insomnia (situational stress – family grief and loss) or When ineffective in chronic insomnia As far as efficacy, there is no difference in efficacy or potential harms for non-benzodiazepines compared with benzodiazepines in treating insomnia. Keeping in mind that there have been some reports of sleep-related behaviours (such as sleepwalking and sleep driving) with zolpidem. Sedating antihistamines, sedating antidepressants and antipsychotics should be avoided in insomnia (unless indicated for primary condition other than insomnia), but there is limited evidence (when used alone) and the risk of adverse effects. There is also limited evidence of effectiveness for complementary medicines, including melatonin and herbal preparations (valerian).

11 Diazepam Flunitrazepam Nitrazepam
AVOID Diazepam Flunitrazepam Nitrazepam Long acting hypnotics such as diazepam, flunitrazepam and nitrazepam should not be prescribed in the older person as they tend to accumulate and cause excessive sedation , unless tolerance has occured over the years, but as far as initiating therapy goes, these should be avoided. Pharmacokinetic and pharmacodynamic changes in an aging body will bring about a whole host of side effects not seen when used in the younger person.

12 2a.Best practice Hypnotic indicated Regular Review Engage Patient
Confirm duration – short term use only Inform tolerance, dependence, rebound insomnia, adverse effects Continuing non-drug therapies Hypnotic indicated 2-5 times per week PRN < 2 weeks Short acting hypnotic Avoid > 60 years – BUT weight it up! Regular Review Review indication for long term use Discontinue when conditions allow Watch for increased doses or resistance to discontinue hypnotics. Engage patient Ensure that hypnotic medicines prescribed at hospital discharge are not continued unnecessarily – when intention maybe for short term use only. Hypnotic indicated Recommendation with regards to avoiding using in 60 year olds is that the adverse events may outweigh the benefits of hypnotic medicines. Regular Review It is difficult to differentiate between aberrant behaviour and genuine long term need so the review process is important to watch out for requests for increased doses or quantity

13 2b. Hypnotics in the Elderly
Meta analysis – NNT 13 >60 yo for 1 month to improve sleep NNT 6 causing adverse effect - fatigue, cognitive impairment, serious events following falls, fractures and MVA In statistics, a meta-analysis combines the results of several studies that address a set of related research hypotheses A meta-analysis found that 13 people aged ≥ 60 years need to be treated with a hypnotic medicine for up to a month, instead of placebo, to improve sleep in 1 person — but treating only 6 people leads to an adverse effect, including fatigue, cognitive impairment and serious events involving falls, fractures and motor Vehicle accidents. A simple but important point is that it is important for the elderly patient to understand that the amount of sleep needed varies with each individual and age. Or course assessed individually.

14 Adverse Events Odds Ratio (95% Cl)
Cognitive Events – memory loss, confusion, disorientation 4.8 Psychomotor events (dizziness, loss of balance) 2.6 Falls 1.6 Motor Vehicle collisions 1.3 Urinary incontinence 1.4 Benzodiazepine use is associated with an increased risk of hip fracture Table 4 – Discusses Adverse Events and hypnotic medicines Odds is the ratio of the probability that the event of interest occurs to the probability that it does not. This is not often estimated by the ratio of the number of times that the event of interest occurs to the number of times that it does not. An odds ratio of greater than 1 indicates that the estimated likelihood of developing disease is greater in the exposed than in the unexposed. An odds ratio less than 1 indicates that the estimated likelihood of developing the disease is less in the exposed than in the unexposed. The figures and clinical studies referred to this evening are all listed in references in your NPS information card, so if there is evidence mentioned here that you wish to pursue further, then please do not hesitate to request for the articles and Ros the NPS facilitator can get them for you.

15 3. Stepped care approach to stopping hypnotic medicines
Simple strategies may start the ball rolling. Lack of evidence for adjunctive therapy in place of hypnotics. 1/3 have trouble stopping Gradual dose reduction may still be required after short-term use Minimise Rebound insomnia Most long term use occurs in the older people and while this can be hard to avoid because of co-morbidities or long-standing dependence, there may be a case for stopping the use in older people as they are at greater risk of harm. However, on the other side of the coin, this may not be appropriate if reviewed against their quality of life. So, it is a grey area that requires judgement on an individual case by case basis. Box 2 of the NPS News is a guide for stopping long term use of hypnotic medicines. I will highlight from that some of the points that is raised in the box. First of all, it is important not to underestimate the value and benefit of brief interventions that can motivate patients to stop and relook at other nondrug therapies. Simple strategies like sending letters or providing self-help contacts and advice are twice as likely to lead to cessation than not raising awareness at all however followup is required for continued support. As relying on this alone is not sufficient to successfully stop hypnotics. Up to a third of those taking long-term hypnotics have difficulty reducing or stopping use. Thus a tailored approach ensuring there is active patient involvement increases participation in interventions for discontinuation. Engaging patient carers can increase the patient’s motivation to take onboard what you have advised. There is also a lack of evidence for using adjunctive drug interventions – TCAs, carbamazepine – in benzo discontinuation.

16 Tapering dose gradually on an individual basis (8-12 weeks)
Time in between dose reductions (several days) Reduce by 10-20% / week Change to equivalent diazepam then reduce dose Reduce one benzodiazpine at a time. Secondly, dose tapering should be done gradually on an individual basis. Short term use (<2 weeks) at recommended therapeutic dose can be stopped abruptly without problem, but there has been rebound insomnia and other withdrawal symptoms associated with abrupt cessation. Even for the very short acting benzos rebound insomnia has been reported with withdrawal syndrome reported with zopiclone. Rebound insomnia usually lasts for 1-3 days with no treatment required, however to minimise this reduce the dose and frequency gradually. Taper dosage gradually on an individual basis Modify dose and/or frequency based on severity of withdrawal symptoms. Allow time to stabilise between dosage reductions (at least several days). NPS recommends aiming for a dose reduction schedule over 8-12 weeks with some flexibility but avoid dragging out to 6 months. Consider referral to a specialist if dose reduction proves too difficult in primary care. Tailored approaches to benzodiazepine dosage reduction may include: • Reducing dose by 10% to 20% per week if it is within or slightly above the recommended amount. • Stabilising on an equivalent dose of diazepam for a few days before dose reduction, if patients were using higher than recommended doses or finding it difficult to reduce the dose of a short-acting benzodiazepine (avoid diazepam in older people). • If multiple benzodiazepines are used, the dose of each drug may be reduced one after the other. Refer to NPS reduction plan for patients in your folders.

17 S Share views and agree on a stopping plan T Taper dosage gradually on an individual basis O Ongoing review and use of non-drug therapies P Provide support and reassurance In summary, NPS has provided and acronym of STOP as a stepped care approach to stopping hypnotic medicines Review – also reviews for rebound insomnia and non-drug therapies continuting.

18 One size does not fit all....
Hypnotic medicines may be acceptable for: Chronic use: No adverse effects Sleeping well Aware about unintentional dependence Attempts have been made to stop but refused or unsuccessful Combination with non-drug therapy might reduce hypnotic dose Review regularly I am sure you can all think of a patient in your experience whom you have tried to get off benzos, but to no avail. And in reality, one size does not fit all. An individual’s perception of pain comes from all kinds of influences including cultural influences that may shape that perception. SO, What if hypnotic medicines cannot be stopped? For patients who have been treated for more than 4–6 months, continued use for insomnia may be acceptable when: • they are sleeping well and have no adverse effects, • they are aware that they may be unintentionally dependent, and • attempts to stop treatment are refused or unsuccessful (see Box 2).19 People who are unable or unwilling to stop long-term treatment should be offered non-drug strategies that might reduce their need for a hypnotic medicine, and should have regular medication reviews.

19 Other NPS resources: NPS News 67, 2010 – Addressing hypnotic medicines use in primary care NPS Prescribing Practice Review 49: Management options for improving sleep Clinical audit: Use of benzodiazepines, zolpidem and zopiclone in insomnia For Patients : Reduction plan for your sleeping tablets Case study 62: Maximising sleep and minimising potential harms

20 Good Night and Sweet dreams

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