Clinical Guideline / Formulary Document Pharmacy Department Medicines Management Services

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1 Clinical Guideline / Formulary Document Pharmacy Department Medicines Management Services INSOMNIA Introduction Insomnia is difficulty in getting to sleep, difficulty staying asleep, early wakening, or nonrestorative sleep despite adequate time and opportunity to sleep, resulting in impaired daytime functioning, e.g. poor concentration, mood disturbance, and daytime tiredness. Insomnia can be classified as follows, according to cause: o Transient insomnia may occur in those who normally sleep well and may be due to an alteration in the conditions that surround sleeping e.g. noise, or to an unusual pattern of rest e.g. shift work or travelling between time zones (jet lag). It may also be associated with acute disorders. May only be short term lasting between 1-4 weeks. o Primary insomnia is insomnia that occurs when no co morbidity is identified. Commonly, the person has conditioned or learned sleep difficulties, with or without heightened arousal in bed. Typically, primary insomnia has a duration of at least 1 month and accounts for about 15 20% of long-term insomnia. o Secondary or chronic insomnia occurs as a symptom of, or is associated with, other conditions, including medical or psychiatric illness, or drug or substance misuse. Insomnia can be long-term (or persistent) lasting for 4 weeks or longer. Non pharmacological management of Insomnia Management of insomnia requires resolution of any stressful precipitant or identification and treatment of underlying causes. Prescribers should routinely provide information on promotion of good sleep habits (sleep hygiene) to make people aware of behavioural, environmental, and temporal factors that may be detrimental or beneficial to sleep. General tips to help with sleep include :- o Establish fixed times for going to bed and waking up (never sleep in the day and avoid sleeping in after a poor night s sleep) o Try to relax before going to bed warm drink, hot bath, reading or a relaxation tape may help. o Maintain a comfortable sleeping environment: not too hot, cold, noisy or bright. o Avoid stimulants such as caffeine and nicotine in the evening. (Consider complete elimination of caffeine from the diet). o Avoid exercise within 4 hours of bedtime (although exercise earlier in the day is beneficial.) o Avoid eating a heavy meal late at night. Hypnotic Drugs There is good evidence for the efficacy of hypnotic drugs in short-term insomnia but they do not treat any underlying cause. Use of hypnotics is associated with adverse effects, such as daytime sedation, poor motor concentration, falls, accidents, cognitive impairment, dependence and withdrawal. In older people, in particular, the magnitude of the beneficial effect of hypnotics may not justify the increased risk of adverse effects (cognitive impairment and risk of falls). Non-pharmacological measures should be considered before prescribing hypnotics. Mersey Care Clinical Guideline / Formulary Document Updated: Jan 2015 Insomnia Next Review: Jan

2 Hypnotic Drugs continued Hypnotic medication should only be initiated when non-pharmacological interventions have been unsuccessful for managing severe, disabling insomnia causing extreme distress and after discussion with the service user. Hypnotics should be prescribed at the lowest effective dose for as short a period as possible, in strict accordance with the licenced indications. In transient insomnia, one or two doses of a short-acting hypnotic may be indicated; whereas in short-term insomnia intermittent doses of a short-acting hypnotic given for no more than 3 weeks (preferably only 1 week) may be appropriate. Chronic insomnia rarely benefits from hypnotics and routine use of hypnotics is undesirable. Tolerance can develop rapidly (in 3 to 14 days with continuous use) and withdrawal after long-term use can lead to rebound insomnia and withdrawal symptoms. A number of hypnotic drugs are licensed for the treatment of insomnia, including shortacting benzodiazepines (loprazolam, lormetazepam and temazepam) and short-acting non-benzodiazepine hypnotics or Z-drugs (zaleplon, zopiclone and zolpidem). If a hypnotic is prescribed, o Use the lowest effective dose for the shortest period possible. The exact duration will depend on the underlying cause, but treatment should not usually continue for longer than 2 weeks. o If there has been no response to the first hypnotic, do not prescribe another. o If the person experiences adverse effects considered to be directly related to an hypnotic, consider switching to another hypnotic. In older people, the magnitude of the beneficial effect of hypnotics may not justify the increased risk of side effects (such as cognitive impairment and increased risk of falls). Benzodiazepine hypnotics Benzodiazepines are effective but many people develop tolerance to their effects, gain little therapeutic benefit from chronic use and become dependent on them (both physically and psychologically). Tolerance to the hypnotic effects of benzodiazepine may be rapid, and may occur within a few days or weeks of regular use A withdrawal syndrome (anxiety, depression, nausea and perceptual changes) which may be prolonged is associated with discontinuation. Rebound insomnia can occur and leads to worsening of the original insomnia symptoms. Due to problems with misuse, benzodiazepines should not be prescribed for any service user with history of substance misuse. Due to concerns over dependence, the UK Committee on Safety of Medicines has issued the following warning: Benzodiazepines should only be used to treat insomnia only when it is severe, disabling or subjecting the individual to extreme stress. Treatment should be at the lowest possible dose and not be continued beyond 4 weeks. Adverse effects of benzodiazepines include: cognitive and psychomotor impairment, depression, emotional blunting, and, less commonly, paradoxical excitement with increased anxiety, irritability, or hyperactive or aggressive behaviour. Older people are more vulnerable to the adverse effects of benzodiazepines (e.g. increased risk of falls, fractured hips, impaired cognitive function and, and occasionally, paradoxical excitement Benzodiazepines increase the risk of road traffic accidents, as they can impair driving performance. Advise the service user not to drive if affected in this way. Mersey Care Clinical Guideline / Formulary Document Updated: Jan 2015 Insomnia Next Review: Jan

3 The Z-drugs Zaleplon, zolpidem and zopiclone (the Z-drugs) are non-benzodiazepine hypnotics. They differ structurally from the benzodiazepines and were developed to overcome some of the disadvantages of the latter e.g. next day sedation, dependence and withdrawal. Z-drugs may be associated with an increased risk of impaired driving ability the next day. Manufacturer summaries of product characteristics (SPCs) state: long-term continuous use is not recommended; a course of treatment should employ the lowest effective dose; a single period of treatment should not exceed 4 weeks including any tapering off; duration of treatment should be 2-5 days for transient insomnia and 2-3 weeks for short term insomnia; Manufacturer SPCs also carry a warning about potential to cause tolerance, dependence and withdrawal symptoms. NICE guidance is available on zaleplon, zolpidem, and zopiclone in the short term management of insomnia (NICE TA77, April 2004). Key points are: o After careful consideration of non-pharmacological measures, hypnotic drug therapy may be considered appropriate but should be prescribed for short periods of time only, in accordance with their licensed indications. o Due to lack of compelling evidence to distinguish between the z-hypnotics, the drug with the lowest acquisition cost should be prescribed. o Switching between these hypnotics should only occur if the service user experiences adverse effects considered to be directly related to the specific agent. These are the only circumstances a hypnotic with a higher acquisition cost is recommended. o Service users who have not responded to one of these hypnotic drugs should not be prescribed any of the others. In common with the benzodiazepines, the sedative effects of the Z-drugs may persist into the next day. Manufacturers warn of the potential for tolerance, dependence and withdrawal symptoms. Zolpidem, zopiclone and zaleplon are now classified as Class C controlled drugs under the Misuse of Drugs Act and listed under Schedule 4, Part 1 of the Misuse of Drugs Regulations. Melatonin Circadin is the only licenced form of melatonin. It is licenced for the short-term treatment of insomnia in adults over 55 years. Melatonin may be of value for treating sleep onset insomnia and delayed sleep phase syndrome in conditions such as visual impairment, cerebral palsy, ADHD, learning disabilities, when appropriate behavioural sleep interventions fail ( off-label use) Treatment with melatonin should be initiated and monitored by a specialist. Other routinely prescribed 'unlicensed' melatonin products are not recommended due to variations in quality and costs. Relevant NICE Guidance NICE Technology Appraisal TA 77. Insomnia - newer hypnotic drugs (TA77). Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia Mersey Care Clinical Guideline / Formulary Document Updated: Jan 2015 Insomnia Next Review: Jan

4 Insomnia - Hypnotics First Line: Relative Cost Notes Zopiclone Suspension mg at bedtime when required. Older adults and hepatic and renal impairment mg tablet at night when required Use for a short period of time only in strict accordance with the licensed indications Non-pharmacological measures should be considered before drug therapy for insomnia. Second Line: Relative Cost Notes Zolpidem 10mg at night when required Older adults and hepatic and renal impairment: 5mg at night when required Risk of drowsiness and reduced driving ability The only acceptable reason to change hypnotics should be intolerance to the current drug. Zaleplon Very short acting due to very short half life; effects on sleep will rapidly wear off The only acceptable reason to change hypnotics should be intolerance to the current drug. Third Line: Relative Cost Notes Temazepam 10mg at night when required; Scheduled 3 controlled drug. Subject to storage, prescribing and recordkeeping requirements. To be used if Z-drugs are not suitable or tolerated. Not to be used if there is history of substance misuse due to risk of dependence and tolerance. Melatonin M/R Consultant initiation only; 2mg at night, 1-2 hours before bedtime for up to 13 weeks. Not Recommended Relative Cost Notes Antihistamines Antidepressants Antipsychotics Long-acting benzodiazepines Clomethiazole Chloral hydrate Use of these agents for their sedative effects is not well supported by evidence. Potential for side effects such as daytime sedation, cognitive impairment and falls is significant. Antihistamine may cause troublesome antimuscarinic effects Benzodiazepines with longer half-lives may cause hangover effects and repeated doses tend to be cumulative Insomnia Next Review: Jan

5 Appendix 1 Licenced indications, cautions and side effects of hypnotics Hypnotic drug Zopiclone Zolpidem License Cautions Key side-effects Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. A course of treatment should employ the lowest effective dose. Duration of treatment should not usually vary from a few days to 2 weeks with a maximum of 4 weeks Not to be re-administered on the same night. Short term treatment of insomnia where the insomnia is debilitating or causing severe distress. Duration of treatment should usually vary from a few days to 2 weeks with a maximum of 4 weeks. Contraindicated: myasthenia gravis, respiratory failure, severe sleep apnoea syndrome, severe hepatic insufficiency and those people with a hypersensitivity to zopiclone or any other ingredient in the product. Use lower doses in renal/hepatic impairment and older adults. Avoid in severe hepatic impairment and respiratory insufficiency. Risk of dependence, tolerance and withdrawal symptoms. Use lower doses in hepatic impairment and older adults Avoid in severe hepatic impairment, respiratory insufficiency, obstructive sleep apnea and myasthenia gravis. In patients with renal insufficiency, there is a moderate reduction in clearance Leave at least 8 hours between taking zolpidem and performing skilled tasks (e.g. driving, or operating machinery) Risk of dependence (especially in alcohol users), tolerance and withdrawal symptoms Bitter or metallic taste; nausea, dizziness, drowsiness, dry mouth, nightmares, rarely lightheadedness, confusion and ataxia Diarrhoea, nausea, vomiting, dizziness, headache, drowsiness, fatigue, confusion, agitation, nightmares, amnesia; ataxia, falls, sleep walking. Insomnia Next Review: Jan

6 Licenced indications, cautions and side effects of hypnotics (continuation) Hypnotic drug Zaleplon License Cautions Key side-effects Treatment of insomnia in people who have difficulty falling asleep only when the disorder is severe, disabling or subjecting the individual to extreme distress. Duration of treatment should be as short as possible with a maximum duration of two weeks. Should not be taken with or shortly after food Lower doses in older adults. Contraindicated in severe renal/hepatic impairment. Contraindicated in sleep apnoea syndrome, myasthenia gravis, and respiratory insufficiency. Risk of dependence, tolerance and withdrawal symptoms Nausea, drowsiness, amnesia, paraesthesia, dizziness, sleep walking, dysmenorrhea, confusion, impaired concentration, depression Temazepam Short term treatment of insomnia up to 4 weeks. Treatment should be at the lowest dose possible. Renal/hepatic impairment, elderly and debilitated patients - use low doses Contraindicated in: acute pulmonary insufficiency, respiratory depression, sleep apnoea, obsessional states, severe hepatic insufficiency, myasthenia gravis Drowsiness, light headedness the next day, confusion and ataxia (elderly), amnesia and dependence. Risk of dependence, tolerance and withdrawal symptoms Melatonin (Circadin 2mg MR) Circadin is indicated as monotherapy for the shortterm treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. Not recommended in hepatic impairment caution in renal impairment Alcohol- reduces effect of melatonin on sleep. Uncommon. Abdominal pain, dyspepsia, irritability, dizziness, dry mouth, migraines, constipation, stomach pain and weight gain. Insomnia Next Review: Jan

7 References 1. NICE(2004) Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia: Technology Appraisal British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders 3. NICE Clinical Knowledge Summaries. Insomnia. Last revised in November Available from Accessed Dec MHRA (2014) Zolpidem: risk of drowsiness and reduced driving ability. Drug Safety Update 7(10), S1. 5. Control of lisdexamfetamine, tramadol, zaleplon, zopiclone and reclassification of ketamine BNF 68 th eds. Available online at: Accessed Dec NICE Key therapeutic topics. Hypnotics. Jan Available at: 8. MHRA Drug Safety Update: Addiction to benzodiazepines and codeine: supporting safer use. July Manufacturer summaries of product characteristics (SPCs) various drugs. Available at: Electronic Medicines Compendium Insomnia Next Review: Jan