“Only one third of Germans sleep soundly,” Ingo Fietze, MD, head of the Interdisciplinary Sleep Medicine Centre, Charité – University Hospital of Berlin, told Medscape Medical News. Consequently, there is a lot to do for sleep specialists. But it cannot be done without the support of family doctors. The latter are often unfamiliar with sleep disorders, however. Medscape spoke to Fietze about why this is so, what possibilities there are to help patients, and what contribution a new class of sleeping pills could make. He is a somnologist who specializes in internal medicine and pulmonology.
Medscape: COVID-19 crisis, Ukraine war, energy crisis, inflation, and climate change — in the past few years, a lot of things have come together to deprive people of sleep. Have you observed an increase in the number of patients with sleep disorders?
Fietze: Our phone rings all day in any case, and our waiting list is long. However, there has been an increase in email inquiries from all over the country.
Medscape: Why are you in such demand? How common are sleep disorders?
Fietze: There is no more common medical condition than a sleep disorder. The most common sleep disorders are insomnia on the one hand, and snoring or breathing disorders on the other. Ten percent of all adults have severe insomnia that requires treatment. Around 17% have sleep apnea that requires treatment.
In Germany, however, there is a serious lack of care in sleep medicine. General physicians have a problem: they don’t know much about sleep. This has to do with the fact that in Germany, sleep medicine has only been taught at individual universities for about 5 years. In addition, there was no continuing medical education in the field of sleep for about 30 years. However, since we have so few sleep specialists and somnology practices, general physicians should really be treating people with sleep disorders as well.
Medscape: What are the most common causes of chronic sleep disorders?
Fietze: The causes are ultimately always genetic, although we still don’t know them for all forms of sleep disorders. Insomnia is due to a deficiency in the sleep-wake cycle. There might be a deficiency in a waking hormone or an excess of a sleeping hormone. Sleep apnea is also due to a predisposition and a specific defect: the nerves that control the muscles in the throat don’t function properly during sleep.
Medscape: Melatonin has been heavily promoted lately. Patients can get it over the counter at the pharmacy. What do you think of these self-medication products?
Fietze: Mostly nonsense, but hats off to the business model: When there is too little somnology care in Germany while many people suffer from sleep problems, a promising product is advertised. However, melatonin only helps when there is a melatonin deficiency. Only the elderly and people with a sleep-wake rhythm disorder tend to have this.
Medscape: What about reimbursable melatonin products? When should they be used?
Fietze: These products are approved for people over age 55 years. In older patients, it makes sense to try melatonin for 2 to 4 weeks, because humans produce less melatonin with age. A deficiency could also be detected by laboratory diagnostics, but that is too time consuming.
Medscape: This year, the European Medicines Agency issued a marketing authorization recommendation for the orexin receptor antagonist daridorexant (see box). The drug has been available on the German market since November. You participated in the pivotal study yourself. Is it a breakthrough in the treatment of insomnia? For which patients is it suitable?
Fietze: It would be a breakthrough if we had enough sleep specialists or physicians practicing sleep medicine. However, the drug does offer an opportunity, since conventional sleeping pills still have a bad reputation today. Orexin receptor antagonists are based on a completely different mechanism of action than the known benzodiazepines and Z-drugs. This is why daridorexant has a chance of being recognized as a sleeping drug by neurologists and psychiatrists, who see many insomniacs. It’s also an opportunity for the many affected people who have so far been treated mainly with psychotropic drugs.
Benzodiazepines, by the way, are also likely to lose their effect over time. It is lower for the benzodiazepine agonists (Z-drugs). When the effect decreases, you have to stop using them. In the home setting, patients often tend to just increase the dose themselves due to psychological strain, also because of a lack of medical supervision during therapy. This leads to dangerous dependencies. Orexin receptor antagonists remain effective longer than benzodiazepines. And like the Z-drugs, they have very few side effects.
How Orexin Receptor Antagonists Work
The orexin receptor antagonists are a new class of sleep disorder drugs that regulate the overactivity of the waking system. They have a sleep-inducing and depressive effect. Their mechanism of action differs from that of benzodiazepines and Z-drugs, which act as GABA-A receptor agonists. Orexin receptor antagonists prevent the orexin A and orexin B neuropeptides from binding to their receptors. These neurotransmitters are produced exclusively by nerve cells in the hypothalamus and are involved in promoting and maintaining wakefulness.
The most common side effects in the pivotal studies were headache and drowsiness. However, serious adverse effects are possible. These include impaired coordination, worsening depression, suicidal thoughts, brief paralysis or hallucinations while falling asleep and waking up, and sleepwalking. Studies have provided no evidence of abuse or of withdrawal symptoms as an indication of physical dependency after stopping the drug.
Daridorexant (Quviviq, Idorsia Pharmaceuticals) is the only orexin receptor antagonist that has been approved in Germany so far. It can be used by adults with insomnia whose symptoms have persisted for at least 3 months and that significantly affect daytime activity. The recommended dose is 50 mg once daily, 30 minutes before bedtime.
Also, with the exception of eszopiclone, there are no long-term studies on existing sleeping pills. On the other hand, there are 12-month studies for the orexin receptor antagonists. Patients did not have negative effects even after they stopped the drug. Patients who have been suffering for years with medicines that no longer help them now have a chance of potentially responding to this new medicine.
Time will tell whether we will keep using conventional sleeping pills first in the future and only prescribe new ones when they stop working, or start using daridorexant immediately as the first-choice therapy.
Medscape: There are more and more medical apps, which now include apps for sleep problems. Some can be prescribed. In some cases, health insurance companies cover the costs. What do you think of such apps and to whom would you recommend them, if applicable?
Fietze: They are worth trying for people who don’t have chronic insomnia yet but feel that their sleep is deteriorating. The sooner they are used, the more effective they are likely to be. There are no studies on whether this can actually prevent a sleep disorder from manifesting or becoming chronic. But you can’t cure insomnia with apps. At most, it can improve insomnia symptoms. Four weeks of vacation can have exactly the same effect. I believe that the most important thing for patients is to first find out about healthy vs disturbed sleep. It’s irrelevant whether they use an app, books, a seminar, etc, to get this information.
Medscape: What do you see as the role of general practitioners in the treatment of sleep disorders?
Fietze: We sleep specialists are waiting for family doctors to cooperate with us. General physicians should take advantage of every opportunity for further education about insomnia. Hopefully, the new drug group will soon lead to more training opportunities.
However, general physicians are unlikely to diagnose “severe insomnia requiring treatment” themselves. However, a correct diagnosis is necessary so that colleagues can prescribe sleep-promoting drugs for longer than 4 weeks without fear of objections.
Up to now, general physicians have often issued follow-up prescriptions as private prescriptions. From my point of view, it is outrageous that insomniacs are the only chronically ill patients who have to pay for their medications themselves. Consequently, general physicians should refer patients with suspected severe insomnia to a sleep specialist who can confirm the diagnosis.
Medscape: Are there patients for whom even you as a sleep specialist can’t do much?
Fietze: We can help most patients. But here’s the problem. Psychiatrists have 100 antidepressants at their disposal; cardiologists have 100 antihypertensives. But we only have four sleeping drugs. If we are not getting anywhere, we combine two or three sleep-promoting drugs for this reason. If even that is not sufficiently effective, the only thing left to do to is to help affected people qualify for a pension, since extremely poor sleep is incompatible with quality of life and performance.
Tips to Help With Treating Sleep Disorders
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Caffeine should be avoided after 5:00 PM. The body needs up to 7 hours to break it down.
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Exercise can improve sleep; 2½ hours of moderate effort, such as Nordic walking, is enough.
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Ventilating the bedroom can ensure sufficient oxygen.
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The optimal temperature for sleeping is between 17 °C and 22 °C (between 62 °F and 72 °F).
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Stressful activities, such as answering emails, should be avoided before going to bed.
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Evening rituals such as relaxation exercises, reading, audio books, or relaxing music can help with falling asleep.
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If the patient is disturbed by snoring or if his or her partner gets up or goes to bed at different times, it may make sense to sleep in different rooms.
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Problems with falling asleep should be handled as calmly as possible. If a patient lies awake for a long time, he or she should get up and do something relaxing, such as reading. The next sleepiness phase usually comes 90 minutes later.
This article was translated from the Medscape German edition.
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