Non-benzodiazepine hypnotic (Z-drug) Pregnancy: §4.6 — Use is not recommended during pregnancy. Zolpidem crosses the placenta; a large amount of data (>1000 pregnancy outcomes) has not shown evidence of malformations after first-trimester exposure, but certain case-control studies reported increased cleft lip and palate with benzodiazepines. Administration in the late phase of pregnancy or during labour has been associated with neonatal hypothermia, hypotonia, feeding difficulties ('floppy infant syndrome') and respiratory depression, including cases of severe neonatal respiratory depression; infants of mothers taking sedative/hypnotics chronically in late pregnancy may develop physical dependence and withdrawal symptoms postnatally — appropriate monitoring of the newborn is recommended. Breast-feeding: small quantities appear in breast milk and use in nursing mothers is not recommended.

Zolpidem tartrate

Brand names: Stilnoct

Zolpidem is a short-acting hypnotic of the imidazopyridine class used for short-term treatment of insomnia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 10 mg

Route: Oral (orodispersible tablet placed on the tongue and allowed to disintegrate before swallowing, with or without water)

Frequency: Once daily, taken as a single intake immediately at bedtime; must not be re-administered during the same night

Max: 10 mg daily — the lowest effective daily dose should be used and must not exceed 10 mg

Source: UK SPC (eMC) for Zalzo 10 mg Orodispersible Tablets, §4.2 (https://www.medicines.org.uk/emc/product/100538/smpc). DURATION: treatment should be given for the shortest possible duration — usually a few days to two weeks, with a maximum of four weeks including tapering off where clinically appropriate. Extension beyond the maximum treatment period should not take place without re-evaluation of the patient's status, since the risk of abuse and dependence increases with the duration of treatment. Prior to starting treatment a discussion should be held with the patient to put in place a strategy for ending treatment, to minimise the risk of dependence, addiction and drug withdrawal syndrome. ELDERLY: elderly or debilitated patients may be especially sensitive, therefore a 5 mg dose is recommended; the recommended doses should not be exceeded. HEPATIC IMPAIRMENT: as clearance and metabolism are reduced, dosage should begin at 5 mg with particular caution in elderly patients; in adults under 65 years the dosage may be increased to 10 mg only where the clinical response is inadequate and the drug is well tolerated. Zolpidem must not be used in severe hepatic impairment as it may contribute to encephalopathy (§4.3). PAEDIATRIC: §4.2 states zolpidem 'is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group'; §4.3 adds that in the absence of data it should not be prescribed for children — no paediatric dose is given. Verify any under-18 use against a children's formulary. NEXT-DAY IMPAIRMENT (§4.4): the risk of next-day psychomotor impairment, including impaired driving ability, is increased if zolpidem is taken within less than 8 hours before activities requiring mental alertness, if a higher-than-recommended dose is taken, or if it is co-administered with other CNS depressants, drugs that increase zolpidem blood levels, alcohol or illicit drugs. OPIOIDS (§4.4): concomitant use may result in sedation, respiratory depression, coma and death — reserve for patients with no alternative, use the lowest effective dose for the shortest time, and monitor closely. The eMC §4.4 was truncated at the source-fetch limit and §4.5 was not retrieved — interactions below are drawn from the US label and the retrieved §4.4. US LABELLING DIFFERS (ACI Healthcare USA, 2023-11-16): the recommended initial dose is 5 mg for women and 5 or 10 mg for men, with a total dose not exceeding 10 mg daily.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to zolpidem tartrate or any of the excipients
Obstructive sleep apnoea
Myasthenia gravis
Severe hepatic insufficiency
Acute and/or severe respiratory depression
In the absence of data, zolpidem tartrate should not be prescribed for children or patients with psychotic illness

Side effects

Nervous system (common): somnolence, headache, dizziness, exacerbated insomnia, cognitive disorders such as anterograde amnesia (amnestic effects may be associated with inappropriate behaviour)
Psychiatric (common): hallucination, agitation, nightmare, depression; uncommon — confusional state, irritability, restlessness, aggression, somnambulism, euphoric mood; very rare — delusion and dependence
Gastrointestinal (common): diarrhoea, nausea, vomiting, abdominal pain
Very rare: respiratory depression; rare — hepatocellular, cholestatic or mixed liver injury (uncommon elevated liver enzymes)
General (common): fatigue, back pain, upper and lower respiratory tract infection; rare — gait disturbance and falls (predominantly in elderly patients and when not taken in accordance with prescribing recommendations)
Withdrawal syndrome on discontinuation — rebound insomnia, muscle pain, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, panic attacks, gastrointestinal disturbances and irritability

Interactions

Opioids — concomitant use may result in sedation, respiratory depression, coma and death; limit dose and duration and monitor closely (§4.4; US label §5.7, §7.1)
CNS depressants, including alcohol and illicit drugs — additive CNS depression, increased drowsiness and psychomotor impairment including impaired driving ability (§4.4; US label §7.1)
Imipramine — decreased alertness observed; chlorpromazine — impaired alertness and psychomotor performance observed (US label §7.1)
CYP3A4 inducers (rifampicin or St John's wort) — combination use may decrease the effect of zolpidem (US label §7.2)
Ketoconazole — combination use may increase the effect of zolpidem (US label §7.2). NOTE: the UK SPC §4.5 was not retrieved in this bundle and must be checked separately.

Clinical monograph

How it works

It acts as an agonist at the benzodiazepine binding site of the GABA-A receptor, enhancing inhibitory GABAergic transmission to promote sleep.

Prescribing in practice

There is a risk of next-day impairment affecting driving and skilled tasks, and the MHRA advises using the lowest effective dose for the shortest time.
Tolerance and dependence can develop, so it should be prescribed for short-term use only.
Complex sleep behaviours such as sleep-walking and sleep-driving have been reported and warrant discontinuation.

Monitoring

Review the ongoing need at each contact and monitor for dependence, daytime sedation and unusual sleep behaviours.

Counselling the patient

Take it immediately before bed and only when you can get a full night's sleep.
Do not drive if you feel drowsy the following day, and avoid alcohol.
Use it for short periods only to reduce the risk of dependence.

Evidence & guidelines

MHRA advice highlights the risk of next-day impairment and the importance of short-term, lowest-effective-dose prescribing for Z-drugs.

Reference: NICE CKS Insomnia; DVLA guidance; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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