表 1. The basic information of sedative-hypnotic drugs for insomnia^[1-3].

镇静催眠药的基本信息^[1-3]

Drug	Mechanism of action	The availability and indications						Dose range for insomnia treatment	Level of potential addiction	Control policies
		China (NMPA)	European Union (EMA)	The United States (FDA)	Japan (PMDA)	Australia (TGA)	The United Kingdom (BNF)
GABA: γ-aminobutyric acid; BZ: benzodiazepine; MT: melatonin; OX: orexin; H: histamine; NMPA: National Medical Products Administration; BNF: British National Formulary; FDA: Food and Drug Administration; EMA: European Medicines Agency; PMDA: Pharmaceuticals and Medical Devices Agency; TGA: Therapeutic Goods Administration.
Benzodiazepines (BZDs)
Diazepam	Indirect GABA agonism of BZ1 and BZ2 receptors	Anxiety disorders, difficulty in sleep initiation	National authorization policy	Anxiety disorders, symptoms of anxiety, and convulsive disorders	Anxiety, depressed mood, muscle cramps	Anxiety disorders, muscle cramps and Panic attacks	Insomnia associated with anxiety	5-15 mg	++	China: Diazepam, alprazolam, and temazepam are classified as second-class psychotropic drugs. America: Diazepam, alprazolam, and clonazepam are classified as List Ⅳ. England: Diazepam, alprazolam, and flunitrazepam are classified as Class C.
Clonazepam		Difficulty maintaining sleep	National authorization policy	Not approved	Insomnia	Severe insomnia	Not available	0.5-2 mg	++
Estazolam		Difficulty initiating sleep, difficulty maintaining sleep	National authorization policy	Short-term management of insomnia	Insomnia and anaesthetic premedication	Not available	Not available	0.5-4 mg	+
Temazepam		Not available	National authorization policy	Short-term treatment of insomnia	Not available	Short-term treatment of insomnia	Short-term treatment of insomnia	7.5-40 mg	++
Lorazepam		Difficulty maintaining sleep, anxiety disorders	National authorization policy	Insomnia and anxiety	Somatic symptoms in psychosomatic diseases	Insomnia due to anxiety, anxiety, and anaesthetic premedication	Short-term treatment of insomnia associated with anxiety	1-4 mg	+
Triazolam		Difficulty initiating sleep, difficulty maintaining sleep or early morning awakening	National authorization policy	Short-term treatment of insomnia	Insomnia	Not available	Not available	0.125-0.5 mg	++
Z-drugs
Zopiclone	Indirect GABA agonism of BZ1 receptor	Difficulty maintaining sleep	National authorization policy	Not approved	Insomnia and anaesthetic premedication	Short-term treatment of insomnia	Short-term treatment of insomnia	3.75-10 mg	+	China: Zopiclone and zolpidem are classified as second-class psychotropic drugs.
Eszopiclone		Difficulty maintaining sleep, difficulty maintaining sleep or early morning awakening	Not available	Insomnia	Insomnia	Not available	Not available	1-3 mg	+
Zaleplon		Difficulty maintaining sleep	Insomnia characterized by difficulty in sleep initiation	Short-term treatment of insomnia	Not available	Not available	Not available	5-10 mg	+
Zolpidem		Difficulty maintaining sleep	Insomnia	Short-term treatment of insomnia characterized by difficulties with sleep initiation	Insomnia (except for insomnia associated with schizophrenia or manic depressive)	Short-term treatment of insomnia	Short-term treatment of insomnia	5-10 mg (6.125-12.5 mg extended release)	+
Melatonin and melatonin agonists
Melatonin	Melatonin agonism of MT1, MT2, and MT3 receptors	Not approved	2 mg modified release for short-term treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 or over	Not approved	Not available	The improvement of sleep quality and morning alertness in patients over 55 with poor quality of sleep	The short-term treatment of insomnia in adults 55 years and over and jetlag	2 mg	No	None
Tasimelteon	Melatonin agonism of MT1 and MT2 receptors	Not approved	Not available	Non-24-hour sleep-wake rhythm disorder and jetlag	Not available	Not available	Not available	Not available	No
Ramelteon		Not approved	Not approved	Insomnia characterized by difficulty with sleep initiation	Insomnia characterized by difficulty with sleep initiation	Not available	Not available	8 mg	No
Orexin receptor antagonists
Suvorexant	Orexin antagonism of OX1 and OX2 receptors	Not yet approved (ongoing application)	Not approved	Insomnia characterized by difficulties with sleep initiation and/or sleep maintenance	Insomnia	Insomnia	Not available	5-20 mg	Low	None
Lemborexant		Not approved (Phase Ⅲ clinical trial)	Not approved	Insomnia characterized by difficulties with sleep initiation and/or sleep maintenance	Insomnia, dose increase should be determined carefully	Insomnia characterized by difficulties with sleep onset and/or sleep maintenance	Not available	5-10 mg	No
Daridorexant		Not approved	Not available	Insomnia characterized by difficulties with sleep initiation and/or sleep maintenance	Not available	Not available	Not available	25-50 mg	No
Antidepressants
Doxepin	Histamine antagonism of H1 receptor	Insomnia: Phase Ⅱ clinical trial, 25 mg; Depression 25 mg	National authorization policy	6 mg (3 mg in the elderly), for insomnia characterized by difficulties with sleep maintenance	Not available	30-300 mg: Depression	75-300 mg: Depression	3-6 mg	No	None