Insomnia is a common physiological and psychological disorder, and long-term insomnia can have serious adverse effects on people’s normal life and work, and can even cause serious accidents. According to the 2002 Global Insomnia Survey, 43.4% of Chinese people had experienced insomnia to varying degrees in the past year, and about 20.0% of them chose to use sedative-hypnotic drugs to solve their insomnia problems. In recent years, the World Health Organization and many domestic and foreign experts have attached great importance to the diagnosis and treatment of insomnia and put forward the treatment principles of “on-demand treatment” and “low-dose intermittent” use of sedative-hypnotic drugs. In order to standardize the clinical application of insomnia drugs, the expert group on the definition, diagnosis and pharmacological treatment of insomnia in China formulated a draft consensus on the definition, diagnosis and pharmacological treatment of insomnia in China in 2004, which has been discussed and modified for many times by domestic neurologists and psychiatrists, and the following expert consensus has been reached.
I. Definition of insomnia
Insomnia is a subjective experience of unsatisfactory sleep duration and/or quality that affects social functioning during the day. According to the common clinical insomnia forms are:
(1) prolonged sleep latency: sleep duration exceeds 30 min;
(2) Sleep maintenance disorder: ≥2 awakenings during the night or early awakening in the morning;
(3) Decreased sleep quality: shallow sleep, excessive dreaming;
(4) Shortened total sleep time: usually less than 6 h;
(5) diurnal residual effects: dizziness, mental fatigue, drowsiness, weakness, etc. in the next morning.
Classification of insomnia
According to the course of the disease, it is divided into:
(1) Acute insomnia: the duration of the disease is less than 4 weeks;
(2) subacute insomnia: the duration of the disease is greater than 4 weeks, less than 6 months;
(3) chronic insomnia: the duration of the disease is more than 6 months.
Three, the diagnosis of insomnia
Insomnia is a primary or secondary sleep disorder, which is easily missed. Only 5% of insomnia patients seek medical attention for this problem, and 70% of patients do not even mention the symptoms to their physicians. This urgently requires clinicians to improve the level of treatment of insomnia. In addition, some neuropsychiatric disorders and other somatic diseases that are manifested only by insomnia should be considered. The general picture includes clinical symptoms, sleep habits (ask the patient and those who are informed), physical examination and laboratory tests (including electroencephalography); special sleep conditions are selected on a case-by-case basis, including:
(1) Sleep diary, sleep questionnaire, visual analogy scale (VAS), etc;
(2) Polysomnography (PSG);
(3) Multiple sleep latency test (MSLT); body movement recorder (actigraph); hypnotic drug use; others (including sleep deprivation electroencephalogram, etc.).
IV. Pharmacological treatment of insomnia.
Benzodiazepines and non-benzodiazepine hypnotic drugs are commonly used. The American Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM2 IV) mentions the non-benzodiazepine hypnotic drug zolpidem as the drug of choice for primary insomnia. Long-term, persistent insomnia should be medicated under the supervision of a specialist. The goals of clinical treatment of insomnia are:
(1) Relief of symptoms: shorten sleep latency, reduce the number of nighttime awakenings, and extend total sleep time;
(2) Maintain normal sleep structure;
(3) to restore social functions and improve the quality of life of patients.
1, benzodiazepines: in the 1960s began to use. The main features are:
(1) non-selective antagonism of γ-aminobutyric acid benzodiazepine (GABA2BZDA) complex receptors, with sedation, muscle relaxation and anticonvulsant triple action;
(2)Prolong the total sleep time and shorten the sleep latency by changing the sleep structure;
(3) Adverse effects and complications are clear, including: daytime sleepiness, cognitive and psychomotor impairment, insomnia rebound and withdrawal syndrome; (4) Long-term heavy use can produce tolerance and dependence.
2, non-benzodiazepine hypnotic drugs: appeared in the 1980s, mainly zolpidem, zopiclone, zaleplon and other drugs, its main characteristics are:
(1) due to selective antagonism of GABA2BZDA complex receptors, so only hypnotic and no sedation, muscle relaxation and anticonvulsant effect;
(2) It does not affect the normal sleep structure of healthy people, and can improve the sleep structure of patients;
(3) therapeutic doses of zolpidem and zopiclone generally do not produce insomnia rebound and withdrawal syndrome.
V. Clinical application of insomnia treatment
1. General principles: Non-benzodiazepines should be chosen as first-line drugs for the treatment of insomnia. The patient’s response to treatment should be monitored and evaluated after starting treatment. If termination of treatment will affect the patient’s quality of life and/or other drugs and non-pharmacological treatment cannot effectively relieve symptoms, treatment should be maintained. Comprehensive treatment of insomnia should include three aspects:
(1) treatment of the etiology;
(2) sleep hygiene and cognitive2behavioral instruction;
(3) medication. In the process of treatment, we should avoid focusing on the use of drugs and ignore other methods, and pay attention to the patient’s initiative.
2, hypnotic drug treatment indications: insomnia secondary or associated with other diseases, the disease should be treated at the same time. The general principle is: whether or not to carry out drug treatment, first of all, help patients to establish healthy sleep habits. Different types of insomnia have different treatment principles: acute insomnia should be treated with early medication; subacute insomnia should be treated with early medication combined with cognitive-behavioral therapy; chronic insomnia is recommended to consult relevant specialists. If the goal is to rapidly relieve symptoms, only temporary or intermittent medication is needed. The patient’s condition should be assessed again after 8 weeks of medication.
3.Continuous and intermittent treatment: For patients who need long-term medication, intermittent medication is recommended from the safety point of view, but there are few relevant studies and the recommended dose varies, so there is no mature intermittent treatment mode, and “on-demand medication” can be recommended. The principle of “on-demand medication” is to consider the use of short half-life sedative-hypnotic drugs according to the patient’s daytime work and nighttime sleep needs, emphasizing that sedative-hypnotic drugs can be used in the evening when symptoms appear, and not recommended for use every night after symptoms stabilize (intermittent or discontinuous use is recommended). Specific strategies for the “as needed” use of sedative-hypnotic medications for which there is clinical evidence are:
(1) Take 15 min before bedtime when sleep is expected to be difficult;
(2) Depending on the need for nighttime sleep, when sleep does not occur after 30 min of bedtime, or when the person wakes up 5 h earlier than usual and is unable to fall asleep again;
(3) Take it according to the needs of daytime activities, i.e., when you have important work or things to do during the day on the second day.
VI. Insomnia treatment for special patients
1. Elderly patients: Elderly patients with insomnia should have a detailed medical history and a rigorous physical examination, and preferably a sleep diary. Preferred treatment for the cause and the development of healthy sleep habits and other non-pharmacological means, if necessary to take drug therapy. Benzodiazepines should be used with caution in the elderly to prevent ataxia, confusion, paradoxical movements, hallucinations, respiratory depression, and muscle weakness, which may lead to trauma or other accidents. It is recommended that elderly patients should be treated with a minimum effective dose and short-term treatment (3-5 d), and gradual increase in dose is not recommended, while close observation is required. Non-benzodiazepine drugs are cleared quickly, so there are relatively few adverse reactions, and are more suitable for elderly patients.
2, children: the effectiveness and safety of hypnotic drugs in the treatment of insomnia in children has not been confirmed, individual cases can be considered for short-term use, but must be closely monitored. If medication is really needed, the patient should be referred to a sleep medicine specialist.
3.Patients during pregnancy and lactation: There is no relevant data to prove the safety of sedative-hypnotic drugs for women during pregnancy and lactation, so it is recommended that these patients be used with caution.
4, perimenopausal patients: For perimenopausal and postmenopausal women with insomnia, common diseases affecting sleep in this age group, such as depressive disorders, anxiety disorders and sleep apnea syndrome, should be excluded first. If these diseases are present, the original disease should be treated at the same time.
5. Patients with respiratory disease: For patients with chronic respiratory disease or mild to moderate sleep apnea syndrome with stable disease, the use of hypnotic drugs should be considered individualized. Benzodiazepines are contraindicated in patients with decompensated chronic obstructive pulmonary disease (COPD), hypercapnia, and decompensated restrictive lung disease, but no adverse respiratory effects have been reported in patients with stable mild to moderate COPD treated with zolpidem and zopiclone for insomnia. Zolpidem and zopiclone do not cause significant impairment in insomnia patients with sleep apnea syndrome, but the efficacy of zaleplon in treating insomnia patients with respiratory disease has not been confirmed.
6, patients with psychiatric disorders: patients with psychiatric disorders often have secondary insomnia symptoms, should be treated according to the principle of specialist treatment to control the original disease, while treating insomnia symptoms. When secondary insomnia occurs in patients with depression, antidepressant treatment is preferred, and non-benzodiazepines can be added as an adjunct. For anxiety disorders with secondary insomnia, daytime treatment with anxiolytic drugs is very effective. When schizophrenia is accompanied by insomnia, antipsychotic medication should be chosen.
VII. Special drugs
1. Antidepressants:
(1) tricyclic drugs: not as the drug of choice for insomnia, partly to help sleep, but its side effects are anticholinergic effects, such as dry mouth, increased heart rate, urinary difficulties, etc.. These drugs should not be used as intermittent “when needed” or before bedtime, most of them reduce sleep latency and awakening during sleep, and increase sleep duration and sleep efficiency. However, most of the drugs reduce slow-wave sleep, reduce REM sleep and increase REM phase activity to varying degrees.
(2) Selective 5-hydroxytryptamine reuptake inhibitors (SSR Is): Most of these drugs do not have specific hypnotic effects, but can treat depression and anxiety symptoms to improve insomnia. SSR Is increase sleep latency and awakening during sleep, reduce sleep duration and sleep efficiency, reduce slow wave sleep, reduce REM sleep time to varying degrees, increase REM phase activity, and can increase periodic limb movements and eye activity in non-rapid eye movement phase (NREM) sleep.
(3) Other antidepressants: Mirtazapine can relieve the symptoms of sleep disorders in depressed patients. Venlafaxine can treat depression with anxiety to improve insomnia. Trazodone has a weak antidepressant effect but a strong hypnotic effect, which can treat sleep disorders and can also be used to treat the rebound of insomnia after the discontinuation of hypnotic drugs.
(4) Antidepressants in combination with zolpidem: In order to shorten the sleep latency, some data show that zolpidem can be used in combination with antidepressants such as SSR Is, especially at the early start of antidepressant treatment.
2, antipsychotic drugs: these drugs are mainly used for sleep disorders of severe mental disorders (such as schizophrenia). Because of the obvious and widespread side effects of these drugs, they are not recommended for patients with insomnia.
Melatonin: Melatonin is involved in the regulation of the sleep and wake cycle and can improve the symptoms of jet lag and delayed sleep phase syndrome (DSPS), but it is not recommended as a hypnotic drug.
4.Alcohol (ethanol): Alcohol is prohibited for the treatment of insomnia.
Eight, insomnia drug treatment indications for drug replacement
1. General indications: The following cases are considered for medication change:
(1) ineffective within the recommended therapeutic dose;
(2) Tolerance;
(3) Serious adverse reactions;
(4) Interaction with drugs used to treat other diseases;
(5) Long-term heavy use ( > 6 months) ;
(6) Elderly patients;
(7) High-risk groups (patients with a history of addiction).
(2) Switching from benzodiazepines to other hypnotic drugs: Currently, many studies have been conducted on chronic insomnia patients who have been treated with benzodiazepines for a long time and replaced them with non-benzodiazepines (zolpidem, zopiclone, etc.). When changing medication, benzodiazepines should be gradually reduced, while non-benzodiazepines should be started and gradually increased to the therapeutic dose, and the process of changing medication should be completed in about 2 weeks.
IX. Indications for termination of drug therapy
When patients feel that they can control their own sleep, they can consider gradually stopping the medication. If insomnia is related to other diseases (depressive disorder) or life events, discontinuation should also be considered after the cause is removed. Discontinuation should take place in steps, over a period of weeks to months. If severe or persistent psychiatric symptoms occur during discontinuation, the patient should be reassessed. A common method of dose reduction is to gradually decrease the nighttime dose and to intermittently use the medication for a period of time after continuous treatment has been discontinued. Abrupt discontinuation of medication is prohibited because insomnia will rebound once the medication is suddenly stopped.
X. Conclusion
The duration of drug treatment for patients with chronic insomnia is still controversial. Generally, the recommended duration of treatment by experts in various countries is a few weeks. However, in clinical work, most experts believe that the duration of treatment is not clearly defined and that the dose and maintenance time should be adjusted according to the patient’s condition. Therefore, pharmacological treatment of insomnia is usually continuous for the first few weeks and intermittent during the follow-up period, depending on the patient’s sleep improvement. Pharmacotherapy should be combined with behavioral therapy and the development of healthy sleep habits. As with all chronic diseases, treatment of insomnia may be long term. Approximately
About 2/3 of patients treated with hypnosis medication have a chronic course with fluctuating symptoms, and repeated short-term medication can prevent the development of drug tolerance and dependence. It is known that the use of hypnotic drugs can affect cognitive function to some extent the following morning, especially for drugs with a long half-life, so short treatment cycles are desirable. In recent years, three international expert seminars of the International Sleep Disorders Forum were held, at which the treatment principles of “on-demand treatment” and “small intermittent doses” of hypnotic drugs were proposed, and the importance of cultivating good sleep habits, psychological and environmental self-regulation was advocated, The conference also advocated the development of good sleep habits, psychological and environmental self-regulation to improve the sleep quality and health of insomnia patients. In order to make more people aware of the importance of sleep health, the conference also designated March 21 each year as World Sleep Day. Reaching a scientific consensus is a difficult task, especially in the area of pharmacological treatment. This consensus is a preliminary discussion on insomnia, which needs to be improved gradually in the future. We hope that domestic experts will continue to deepen and update the research results through clinical work and mutual discussion and consultation.
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