Stilnox (Stilnoks)

Instructions for use: Stilnox (Stilnox)

Brief reference information compiled from official German sources (Gelbe Liste, Fachinfo, Apotheken Umschau). It does not replace a doctor’s consultation or the package insert. This is a prescription medicine — use it only as directed by a doctor.

Active substance

Zolpidem tartrate (Zolpidemtartrat). One Stilnox tablet contains 10 mg of zolpidem tartrate (corresponding to 8.03 mg of zolpidem). A Z-hypnotic of the imidazopyridine group, a GABA-A agonist (ω1/BZ1 receptor), ATC N05CF02. Manufacturer: Sanofi-Aventis Deutschland GmbH.

Available forms

In Germany, Stilnox is available only as film-coated tablets of 10 mg (engraving «SN 10», retail packs of 10, 14, 20 and 28 pcs; there is also a clinical (hospital) pack of 150 pcs (15×10), not available at retail). The tablet has a score line and divides into equal halves — this provides a 5 mg dose for the elderly. There is no separate 5 mg Stilnox form; zolpidem 5 mg is available as generics (Zolpidem-ratiopharm, HEXAL, AL, STADA, etc.).

Indications

Short-term treatment of sleep disturbances (insomnia) in adults. According to the Fachinfo, treatment is indicated only for insomnia of clinically significant severity or when it becomes a serious burden for the patient.

How to take

The dose and duration of the course are determined by the doctor. According to the official prescribing information: for adults, 10 mg once in the evening immediately before bedtime, washed down with water; use the minimum effective dose. The maximum daily dose is 10 mg; repeat intake on the same night is prohibited. For elderly and debilitated patients, as well as in cases of impaired liver function — 5 mg (½ tablet). The course is as short as possible: as a rule, from several days to 2 weeks, no more than 4 weeks including the phase of gradual withdrawal; do not discontinue abruptly — the dose is reduced gradually.

Contraindications

• Hypersensitivity to zolpidem or excipients (contains lactose)
• Myasthenia gravis (myasthenia gravis)
• Acute and/or severe respiratory insufficiency
• Sleep apnoea syndrome
• Severe hepatic failure (risk of encephalopathy)
• A history of episodes of unusual sleep behaviour after taking zolpidem

Possible side effects

• Drowsiness the next day, headache, dizziness
• Worsening of insomnia, cognitive impairment up to anterograde amnesia
• Hallucinations, agitation, nightmares, depression
• Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdominal pain
• Fatigue/exhaustion
• Infections of the upper and lower respiratory tract, back pain
• In the elderly — unsteadiness of gait and risk of falls

Special precautions

• Not recommended for children and adolescents under 18 years, as well as during pregnancy and breastfeeding (according to sections 4.2 and 4.6 of the Fachinfo — a recommendation, not a formal contraindication)
• Prescription medicine (verschreibungspflichtig) — in Germany dispensed only on a doctor’s prescription
• The risk of abuse and physical/psychological dependence increases with the dose and duration of intake; withdrawal only by gradual dose reduction (otherwise withdrawal syndrome and rebound insomnia)
• Complex sleep behaviours have been described: sleepwalking, «sleep-driving», preparing and eating food, telephone conversations with no subsequent recollection — in such episodes the medicine is discontinued immediately
• Alcohol during treatment is strictly excluded: it unpredictably enhances the effect and the risk of dangerous sleep behaviour
• Strongly affects the ability to drive: morning drowsiness, slowed reaction; between intake and driving/operating machinery — at least 8 hours; ensure 8 hours of uninterrupted sleep
• Concurrent use with opioids and other CNS depressants — risk of respiratory depression and coma; only at the doctor’s decision

Sources: www.fachinfo.de, www.gelbe-liste.de, www.gelbe-liste.de, www.apotheken-umschau.de