Lormetazepam

Intermediate-acting benzodiazepine hypnotic

ATC code: N05CD06 (Lormetazepam)

Brand names

Noctamid, Aldosomnil, Sedaben

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.

Indications

Chronic insomnia in adults under 55

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

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

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.

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Official sources

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

AEMPS / CIMA

Spanish Medicines Information Centre (CIMA)

Label dated: 03/01/2024

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

PregnancyFDA D

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.

Frequently asked

What is Lormetazepam used for?

Lormetazepam is evaluated for the following indications with varying evidence strength: Chronic insomnia in adults under 55 (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?

FDA category D. 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.

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.

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.