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Independents' Day

Need to Know - insomnia

Insomnia expert Professor Kevin Morgan answers GP Dr Mandy Fry’s questions on the use of melatonin, helping patients off hypnotics and choosing a Z-drug

Insomnia expert Professor Kevin Morgan answers GP Dr Mandy Fry's questions on the use of melatonin, helping patients off hypnotics and choosing a Z-drug

1. What role, if any, does melatonin play in the treatment of insomnia? I have several patients who buy it when visiting the USA – are there any concerns?

41214893Melatonin has an important role in controlling the circadian rhythm and can shift the timing of sleep-wake cycles. Where sleep difficulties are due to circadian desynchronisation – for example in jet lag – melatonin may help.

In the US melatonin is classified as a dietary supplement and is not subject to Food and Drug Administration regulations and is freely available there OTC. But this June a prolonged-release melatonin tablet called Circadin was licensed in the UK for the short-term treatment of primary insomnia in adults aged 55 and over. A full list of cautions, contra-indications and interactions can be found in the BNF.

But it is important to remember that just because melatonin is endogenous, its use as medication is not necessarily benign. Side-effects include pharyngitis, back pain, headache and asthenia. Caution is needed when prescribed with cimetidine and oestrogens, both of which increase plasma concentrations of melatonin. For the same reason, concomitant use with fluvoxamine should be avoided.

Since melatonin is a chronobiotic – rather than a conventional sedative-hypnotic – it's unlikely to benefit patients whose sleep difficulties are not related to a circadian rhythm disorder. Some assessment of the patient's sleep routines and history should inform prescribing.

A daily sleep diary maintained for one to two weeks can help here. A diary developed at our department is available for download (right). Look for irregular sleep and bed times, or sleep periods that advance each night. It should also be emphasised that, in the UK, melatonin is only licensed for the treatment of primary insomnia – without physical or psychological comorbidity – and is unlikely to solve the sleep problems of many, if not most, older patients.

2. We often try to advise patients with insomnia about sleep hygiene. What would you say is the best advice to give? Are there any resources we can signpost people to?

In the NICE guidelines on the use of Z-drugs to manage insomnia, sleep hygiene is considered fundamental to management. Sleep hygiene is an evidence-based collection of advice that can improve sleep quality and increase the likelihood of other treatments working. Poor sleep hygiene will frustrate the most effective treatment.

41214896Sleep hygiene advice is better ‘explained' than ‘prescribed', although handouts are very useful to reinforce messages.

In the Improving Access to Psychological Therapies (IAPT) initiative, sleep hygiene has been included in the low-intensity training programme. We have also produced a complete list of sleep hygiene advice, suitable for patients, as part of our sleep diary. Both are available for download (right).

3. Patients who have been on hypnotics for some time often have difficulty coming off them and seem to get rebound insomnia. How long would you expect rebound insomnia to last?

Rebound insomnia, characterised by increased sleep latencies and sleep fragmentation, is a direct consequence of drug tolerance. Unless informed otherwise, patients may interpret rebound as the re-emergence of their original insomnia, an interpretation that reinforces their perceived need for hypnotic drugs.

Most hypnotics, if taken for months or years, will produce some degree of rebound insomnia if abruptly discontinued.

The timing and intensity of rebound will depend on a number of factors including the drug's elimination half-life, and the habitual dose and frequency of use.

Drugs such as temazepam with intermediate elimination half-lives tend – if they've been used every night – to have a marked rebound effect on the first or second night following withdrawal. This can be expected to resolve after five or six nights. But patients can show wide individual differences.

Older, longer-acting hypnotics like nitrazepam show a more delayed, and less intense rebound because blood concentrations fall more gradually.

In practice, the pharmacological and psychological consequences of withdrawal are often difficult to separate, since both can disturb sleep in similar ways.

4. Is there a regimen for withdrawing that works better than others?

Tapered withdrawal can mitigate both the pharmacological and psychological consequences of withdrawal, with a regime suited to a patient's profile. Where drugs have been taken for only weeks or months, a planned and progressive reduction succeeds for most patients. But there is no ‘one size fits all' tapering regime.

Many long-term users have sleep profiles indistinguishable from those seen in untreated chronic insomnia. So patients coming off hypnotics will need support to manage their sleep problems without drugs.

Again, sleep hygiene advice is essential, and insomnia-focused CBT has also been found effective in both promoting and maintaining withdrawal from long-term hypnotic use.

5. Older patients often describe difficulty in sleeping yet this seems to have no detrimental effect on their daytime functioning. Does it still count as insomnia?

In the major diagnostic systems DSM-IV2 and ICSD-23, criteria for insomnia include:

• a complaint of difficulty initiating or maintaining sleep, or of non-restorative sleep despite opportunities to sleep

• occurring three or more times per week

• persisting for at least a month

• associated with impaired social or occupational functioning.

So if there are no adverse daytime consequences, there is no insomnia. A useful index is fatigue, and to ask patients whether they feel they perform better after nights when they sleep better.

6. Is it true that the amount of sleep people need often decreases as they get older?

As we age – whether we are growing up or growing old – our sleep becomes shorter, lighter and more fragmented. This appears to be a universal experience.

Most older people do not report poor sleep, indicating that these changes are not a sufficient cause for complaints. It's possible that some older people may misinterpret changes in sleeping patterns. Such a case calls for advice and education.

Sleep complaints are most common in later life, but there are actuarial as well as physiological reasons. Any chronic non-fatal condition with an incidence across the lifespan (like insomnia) will accumulate in old age. So just because insomnia is prevalent in old age does not mean it is often because of old age. When older patients report sleep difficulties, always ask them when their sleep first became a problem. The answer may help to frame their treatment and your expectations.

7. Are OTC remedies such as Nytol and the various herbal remedies safe? Can they lead to tolerance and dependence?

It's important to draw a distinction between regulated OTC remedies like Nytol – which contain active ingredients – and herbal remedies. Evidence of efficacy for the herbal insomnia treatments – many of which contain valerian – is sparse. Mild side-effects of valerian – headache, nausea – have been reported in trials. So, while herbal sleep remedies seem to do little harm they also appear to do little good.

Nytol, on the other hand, contains the antihistamine diphenhydramine hydrochloride. Because it causes drowsiness, it should be avoided by those operating machinery, and may interact with other CNS medications to amplify sedation. In healthy adults the elimination half-life ranges from two to nine hours, so residual sedation is possible.

Diphenhydramine is also contraindicated in a range of conditions including asthma, glaucoma, and stenosing peptic ulcer. It is known to be a drug of misuse when combined with alcohol, and tolerance to it does occur.

8. There is often significant pressure from PCTs to cut prescribing of the Z-drugs. Given that we usually try to avoid prescribing hypnotics as far as possible, are there any circumstances when you would choose a Z-drug in preference to an older drug? How would you determine which Z-drug to use?

On clinical grounds, Z-drugs should be considered if the patient experiences adverse effects – including adverse behavioural effects like excessive or residual sedation. That said, I agree with the current NICE guidelines that, in terms of efficacy and clinical profiles, there is little evidence to distinguish between zaleplon, zolpidem, zopiclone or the shorter-acting benzodiazepine hypnotics.

But from a strategic point of view there is one major difference. While zaleplon is licensed for a maximum of two weeks' treatment, both zolpidem and zopiclone are licensed for four. Make a judgment based on the likely duration of the sleep problem – and the cost of the hypnotic.

9. If we've excluded psychiatric illness such as depression as the underlying cause, does the pattern of the insomnia have any predictive value in assessing likely response to treatment? Is it any help in deciding on treatment strategies?

In essence all insomnias can usefully be regarded as ‘sleep onset' insomnias, as the problem of waking up in the night is really the problem of getting back to sleep. One of the key constructs that has greatly helped our understanding of chronic insomnia is ‘cognitive arousal'. Patients sometimes describe this as a ‘racing mind', an ‘overactive mind', or an inability to ‘switch off'. Whatever wakes a person up in the night, it is often cognitive arousal that prevents them from returning to sleep.

Psychological mechanisms interact with homeostatic mechanisms so that greater sleepiness at the beginning of the night will more likely override the racing mind. But with sleepiness somewhat diminished, we become more vulnerable to intrusive thoughts if we wake during the night. Addressing arousal, either pharmacologically or psychologically, becomes the therapeutic target.

Cognitive behaviour therapy for dealing with arousal and other aspects of dysfunctional sleep can provide lasting benefits and, where available, should be tried ahead of pharmacological approaches. But if returning to sleep is the problem, a hypnotic such as temazepam with a half-life of 14 to 15 hours can be effective – but again, only in the short term.

10. What are the best strategies for addressing insomnia in children? Is there any association between insomnia and other sleep disorders such as night terrors and sleepwalking?

Night terrors and sleepwalking are slow-wave sleep parasomnias. Both are more common in children than adults. Among predisposed children, night terrors and sleepwalking are also more likely when the child is overtired, so in that sense there could be a relationship with insomnia. Otherwise, they are independent conditions.

The best tried-and-tested approach to the management of insomnia in children is a behavioural programme, which begins with sleep hygiene and can include the process of sleep training.

Both require the full co-operation of parents and, since the process may often involve some crying or remonstration on the part of the child, preparing the parents is essential. Importantly, parents should be helped to appreciate that the crying child is not trying to annoy them, but that if they return repeatedly to the crying child they are training their child to cry for comfort. Remember that children don't need to be taught how to sleep, but some need to be taught how to sleep on their own.

Calming pre-bedtime routines that occur at the same time each night, optimising the child's sleep environment (temperature, lighting, quietness, comfort, removal of distractions), avoiding caffeinated drinks at all times, avoiding energetic play in the evening, and imposing a consistent bedtime all contribute to the sleep hygiene package.

Maintained over a period of four to six weeks, such a regime can dramatically improve sleep and reduce bedtime tantrums in some children.

Sleep training goes further. When the child cries after going to bed, the parents are asked to monitor the child's wellbeing from a distance, but not to respond by visiting the child's bedroom. Sooner or later (at first, often later) the child falls asleep. Combined with all the rules of sleep hygiene, the regime has a very high likelihood of success, but it can also cause distress to parents. Less distressing alternatives include responding to the child at progressively longer and longer intervals (first two minutes, then four, up to, say, 20 minutes).

For success, such programmes require on-the-ground parental support and training, and local child and adolescent mental health services should be able to offer advice.

11. Is there any place for medication, given that parents are usually exhausted by the time they seek medical help?

Adult hypnotics are best not given to children. But in cases of severe insomnia where behavioural approaches have failed or look likely to fail – particularly in children with such conditions as cerebral palsy, ADHD or autism – an unlicensed imported paediatric melatonin preparation is available. Quality control is regulated by MHRA. Since the use of melatonin in children is generally supervised by a consultant paediatrician, sleep disorders of this severity are best managed in specialised services.

Professor Kevin Morgan is a chartered psychologist and director of the Clinical Sleep Research Unit at Loughborough University. He has served as a consultant to NICE and MHRA in relation to hypnotics and insomnia management

Competing interests None declared

Sleep diary from Loughborough Sleep Researche Centre Sleep Diary and Sleep Hygiene Fact Sheet Sleep hygiene advice from Improving Access to Psychological Therapies training manual IAPT training manual thps What I will do now What I will do now

Dr Fry considers the answers to her questions

I will be mindful of the fact that melatonin interacts with oestrogens and feel better informed when patients who travel to the USA ask me about it. It's interesting that a form of melatonin is now available in the UK although I am unlikely to prescribe it.
I will also consider the use of a sleep diary and will ask older patients particularly how lack of sleep impacts upon their daytime functioning before responding to their requests for hypnotics.
The leaflet will be helpful in discussing sleep hygiene and I will also explore relaxation strategies and access to CBT from our primary care mental health workers.
With regard to children I will continue to encourage parents to utilise behavioural strategies and warn them that it might be more distressing in the short term.
It is also useful to know that for particular cases where behavioural management is difficult that the specialist services do have potential access to suitable medication.

Dr Mandy Fry is a GP in Cirencester, Gloucestershire, and senior primary care lecturer at Oxford Brookes University

Sleep hygiene Insomnia

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