Lormetazepam

Intermediate-acting benzodiazepine hypnotic

ATC code: N05CD06

Brand names: Noctamid, Aldosomnil, Sedaben

Updated 21 Jul 2026 · Methodology

Indications

Insomnia and sleep disorders

Second line

Benzodiazepines work for acute insomnia but are not foundation therapy. 2017, 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.

Short courses up to 4 weeks only.

Sources

ICD-10: G47.0 · ICD-11: 7A00

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.

Insomnia in older adults

Not recommended

In patients over 65, lormetazepam is high-risk – on the 2023 Beers list. Falls, hip fractures, and cognitive impairment risk is 1.5–2× higher in older adults. AGS and recommend CBT-I first-line; if pharmacotherapy is needed – melatonin 1–3 mg or a sedating antidepressant short-term. When unavoidable, reduce to 0.5 mg and limit to a few nights.

Sources

ICD-10: G47.0 · ICD-11: 7A00

How to read tiers A–F

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

Mechanism of action

An intermediate-acting benzodiazepine with a 10–12-hour half-life. Binds the benzodiazepine site of GABA-A receptors and enhances inhibitory neurotransmission. Metabolized solely by glucuronidation (no CYP involvement), making it easier to use in hepatic impairment and older patients. In Spain it is among the most prescribed benzodiazepine hypnotics under brands Loramet and Noctamid.

Safety

Boxed warning

FDA boxed warning (2016): concurrent benzodiazepines and opioids carry risk of profound sedation, respiratory depression, and death. Co-prescribe only when alternatives are absent, at lowest effective doses and shortest duration.

Contraindications

Benzodiazepine hypersensitivity
Severe respiratory failure
Untreated obstructive sleep apnea
Severe hepatic impairment
Acute alcohol or opioid intoxication
Myasthenia gravis
Acute angle-closure glaucoma

Serious adverse effects

Physical and psychological dependence, withdrawal
Paradoxical reactions (agitation, aggression) in older adults and children
Respiratory depression with opioids or alcohol
Falls and fractures in older adults
Cognitive decline and dementia risk with long-term use

Common adverse effects

Daytime drowsiness and residual sedation
Dizziness
Weakness and ataxia
Anterograde amnesia
Dry mouth

Pregnancy: can you take Lormetazepam?

T1 association with cleft lip/palate is weak and not confirmed in large cohorts. T3 use is linked to floppy infant syndrome and neonatal withdrawal. Avoid when possible; for severe pregnancy insomnia, non-pharmacological measures are first-line.

Breastfeeding: can you take Lormetazepam?

Milk concentrations are low. Single doses pose minimal infant sedation risk. With regular use, monitor infant drowsiness and weight gain.

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take 30 minutes before bed and ensure 7–8 hours of uninterrupted sleep (otherwise morning residual sedation persists). Do not combine with alcohol, opioids, or other sedatives – severe respiratory depression risk. Taper gradually: after more than 4 weeks of use, reduce 10–25% per week to prevent withdrawal (anxiety, insomnia, tremor, seizures in severe cases). With chronic use, transition to CBT-I with gradual pharmacotherapy taper.

Label mentions7 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

Majoropioidesclass named in the label
«Riesgo por el uso concomitante con opioides: Debe tenerse precaución en pacientes con:»
AEMPS, section 4.4 · Open on CIMA
Moderateanticonceptivos hormonalesclass named in the label
«En pacientes tratados de forma crónica con otros medicamentos que afectan a las funciones circulatoria y respiratoria (tales como agentes beta-bloqueantes, glucósidos cardioactivos, metil- xantinas)…»
AEMPS, section 4.5 · Open on CIMA
Moderatebetabloqueantesclass named in the label
«En pacientes tratados de forma crónica con otros medicamentos que afectan a las funciones circulatoria y respiratoria (tales como agentes beta-bloqueantes, glucósidos cardioactivos, metil- xantinas)…»
AEMPS, section 4.5 · Open on CIMA
Moderatedigitálicosclass named in the label
«En pacientes tratados de forma crónica con otros medicamentos que afectan a las funciones circulatoria y respiratoria (tales como agentes beta-bloqueantes, glucósidos cardioactivos, metil- xantinas)…»
AEMPS, section 4.5 · Open on CIMA
antiepilépticosclass named in the label
«Se puede intensificar sus efectos de forma recíproca al administrar de forma conjunta con medicamentos que tengan un efecto sedante a nivel central (tales como medicamentos neurolépticos, sedantes…»
AEMPS, section 4.5 · Open on CIMA
antihistamínicosclass named in the label
«Se puede intensificar sus efectos de forma recíproca al administrar de forma conjunta con medicamentos que tengan un efecto sedante a nivel central (tales como medicamentos neurolépticos, sedantes…»
AEMPS, section 4.5 · Open on CIMA
Theophylline
«La administración de teofilina o aminofilina puede reducir los efectos sedantes de las benzodiazepinas incluido lormetazepam.»
AEMPS, section 4.5 · Open on CIMA

Check interaction with another drug

Opens the checker prefilled with this drug. Pick the second one from your regimen.

Open checker

Summary of a multi-drug list →

Medicine list: everything you take in one place →

Frequently asked

What is Lormetazepam used for?

Lormetazepam is evaluated for the following indications with varying evidence strength: Insomnia and sleep disorders (evidence tier B), Insomnia in older adults (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Lormetazepam?

Common side effects of Lormetazepam (≥ 1 in 100): Daytime drowsiness and residual sedation, Dizziness, Weakness and ataxia, Anterograde amnesia, Dry mouth. See the Safety section for uncommon and serious reactions.

Is Lormetazepam safe during pregnancy?

Is Lormetazepam compatible with breastfeeding?

Milk concentrations are low. Single doses pose minimal infant sedation risk. With regular use, monitor infant drowsiness and weight gain.

Can you drink alcohol while taking Lormetazepam?

Do not combine with alcohol, opioids, or other sedatives – severe respiratory depression risk.

Who should not take Lormetazepam?

Lormetazepam is contraindicated in: Benzodiazepine hypersensitivity; Severe respiratory failure; Untreated obstructive sleep apnea; Severe hepatic impairment; Acute alcohol or opioid intoxication. Full list in the Safety section.

Does Lormetazepam carry an FDA boxed warning?

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 03/01/2024

Other drugs in this group

Melatonin, Olanzapine, Paliperidone, Passionflower (Passiflora incarnata, aerial parts), Phenibut, Valeriana officinalis (root extract), Bromazepam, Droperidol