Insomnia and sleep disorders

ICD-10 G47.036 drugs

Drugs used for this condition

BLormetazepamSecond line · Intermediate-acting benzodiazepine hypnoticBenzodiazepines work for acute insomnia but are not foundation therapy. AASM 2017, NICE 2022, and the Spanish SES 2024 consensus place CBT-I as first-line and short-course pharmacotherapy as second-line when CBT-I is unavailable or ineffective. Lormetazepam 1–2 mg 30 minutes before sleep reduces sleep latency and night awakenings. Course is capped at 4 weeks to prevent dependence. In Spain, despite restrictions, long-term prescribing is common – this carries higher risk of falls, fractures, and dementia with multi-year use.
BZolpidemSecond line · Non-benzodiazepine hypnotic (Z-drug), imidazopyridineZolpidem is a non-benzodiazepine Z-hypnotic. AEMPS authorises it for insomnia in short courses up to 4 weeks, including the taper. SEN 2022 and AASM 2021 place cognitive-behavioural therapy for insomnia (CBT-I) first; pharmacotherapy (zolpidem, eszopiclone, prolonged-release melatonin) is second-line when CBT-I fails or is unfeasible. Cochrane 2018 shows Z-drugs shorten sleep onset by 18–22 minutes – clinically modest. Long-term use leads to tolerance and dependence. The marketing position of «a safe alternative to benzodiazepines» does not match the regulatory stance: FDA and EMA added warnings about parasomnias and complex sleep behaviours. If zolpidem was prescribed without discussion of CBT-I, consider seeking a second opinion.
CMelissa officinalis (leaf extract)Add-on therapy · Herbal sedative, EMA HMPC traditional herbal medicinal productLemon balm is used for mild sleep disturbance and nervous tension – often combined with valerian. EMA HMPC in 2013 confirmed traditional-use status for these indications based on 30 years of practice. Several small RCTs with the proprietary Cyracos extract (Naturex) showed modest improvement in subjective sleep quality and lower anxiety, but samples were small and trials manufacturer-funded. No positive systematic review exists. The AASM 2021 insomnia guideline does not mention lemon balm. For mild episodic insomnia a short course of 300–600 mg of extract in the evening is acceptable. If the herb was prescribed as monotherapy for severe chronic insomnia, consider seeking a second opinion; the evidence for first-line CBT-I is far stronger.
CValeriana officinalis (root extract)Add-on therapy · Herbal sedative, EMA HMPC traditional herbal medicinal productValerian is used for mild sleep disturbance and nervous tension. EMA HMPC in 2016 confirmed traditional-use status for this indication – the decision rests on 30 years of European practice, not on large RCTs. The Taibi systematic review (Sleep Med Rev 2007) pooled 18 placebo-controlled studies and concluded that valerian is safe but shows no clinically meaningful effect on sleep latency, total sleep time or sleep quality. Individual RCTs give a weak positive signal, others give none. The AASM 2021 insomnia guideline does not list valerian as a proven option. First-line treatment for chronic insomnia is cognitive-behavioural therapy for insomnia (CBT-I), not herbal products. If valerian was offered as a replacement for prescription hypnotics or a long-term course for severe insomnia, consider seeking a second opinion. For episodic nervous tension a single dose of 400–600 mg of extract taken 30–60 minutes before bed is reasonable.
DPassionflower (Passiflora incarnata, aerial parts)Add-on therapy · Herbal sedative, EMA HMPC traditional herbal medicinal productPassionflower is positioned as a sleep aid, often combined with valerian and lemon balm. EMA HMPC recognises use for «transient sleep disturbance linked to nervous tension». Passionflower monotherapy RCTs in insomnia are few: one study with a 2 g/day infusion showed improvement in subjective sleep quality, but the sample was 41 people. The AASM 2021 guideline does not include passionflower. For mild episodic insomnia a short course is acceptable. For chronic insomnia the evidence base of CBT-I is substantially stronger.

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

How to read tiers A–F

Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit