1. Introduction
Zopiclone is a non-benzodiazepine hypnotic agent used for the short-term treatment of insomnia. It enhances the activity of gamma-aminobutyric acid (GABA), a neurotransmitter that induces sedation and sleep. Zopiclone is effective in reducing sleep onset time, improving sleep duration, and minimising nocturnal awakenings.
2. Indications
- Short-term treatment of insomnia, including:
- Difficulty falling asleep
- Frequent nocturnal awakenings
- Early morning awakenings
- Situational or transient insomnia (e.g., stress-related).
3. Dosage
Adults:
- Usual dose: 3.75–7.5 mg orally at bedtime.
- Maximum dose: 7.5 mg once daily.
Elderly:
- Start with 3.75 mg once daily at bedtime; adjust based on response and tolerability.
Children (<18 years):
- Not recommended for use in children and adolescents.
Patients with hepatic or renal impairment:
- Start with 3.75 mg once daily and monitor closely for side effects.
4. Administration
- Take immediately before bedtime.
- Do not take zopiclone if you cannot dedicate at least 7–8 hours to sleep.
- Avoid alcohol while using zopiclone, as it may enhance sedative effects.
5. Forms Available
- Tablets: 3.75 mg, 7.5 mg
6. Side Effects
6.1 Common Side Effects:
- Drowsiness or sedation the next day
- Dry mouth
- Bitter or metallic taste
- Dizziness
6.2 Less Common Side Effects:
- Headache
- Fatigue
- Nausea
6.3 Rare but Serious Side Effects:
- Amnesia or memory impairment
- Sleepwalking or other complex behaviours (e.g., sleep-driving, eating during sleep)
- Severe allergic reactions (e.g., angioedema, rash)
- Respiratory depression (rare, especially in those with pre-existing conditions)
7. Warnings
- Dependency Risk: Long-term use or misuse may lead to dependence and withdrawal symptoms upon discontinuation.
- Impaired Alertness: Zopiclone may impair the ability to drive or operate machinery the next day, even at recommended doses.
- Complex Sleep Behaviours: Rarely, patients may engage in activities like sleep-driving or eating during sleep with no memory of the event.
8. Precautions
- Use cautiously in patients with a history of substance misuse or alcohol dependency.
- Avoid in patients with severe hepatic impairment, as clearance is reduced.
- Avoid combining with other CNS depressants (e.g., opioids, benzodiazepines) to minimise the risk of excessive sedation or respiratory depression.
9. Interactions
- Alcohol: Increases sedation and impairs motor function. Avoid concurrent use.
- CYP3A4 inhibitors (e.g., ketoconazole): May increase zopiclone levels and prolong sedative effects.
- CNS depressants (e.g., opioids, benzodiazepines): Increased risk of sedation, respiratory depression, and impaired motor skills.
- Rifampin and other CYP3A4 inducers: May reduce zopiclone efficacy.
10. Monitoring Parameters
- Assess for improvement in sleep onset, duration, and quality.
- Monitor for signs of dependency or misuse in long-term use.
- Evaluate daytime alertness and symptoms of residual sedation.
11. Use in Children
- Not recommended for use in children under 18 years due to limited safety and efficacy data.
12. Use in Pregnancy
- Category C: Use only if the potential benefit justifies the risk to the foetus. Neonates exposed during late pregnancy may experience withdrawal symptoms or respiratory depression.
13. Use in Elderly
- Use cautiously at the lowest effective dose (3.75 mg) to minimise the risk of sedation, falls, or cognitive impairment.
14. Use in Kidney Disease
- Dose adjustment is required in severe renal impairment; start with 3.75 mg and monitor for side effects.
15. Use in Liver Disease
- Use cautiously in mild to moderate liver impairment; reduce the dose to 3.75 mg. Avoid in severe hepatic impairment.
16. Patient Counselling Points
- Take zopiclone only when you have time for 7–8 hours of uninterrupted sleep.
- Do not exceed the prescribed dose or duration of treatment (usually ≤4 weeks).
- Avoid alcohol and other sedatives while using zopiclone.
- Report any unusual behaviours during sleep, such as sleepwalking, to your doctor immediately.
- Inform your doctor if you experience persistent daytime drowsiness, memory issues, or signs of dependency.
17. Table of Brand Names, Manufacturer, and Prices in USD
Brand Name | Manufacturer | Strength/Dosage Form | Price (USD) |
---|---|---|---|
Imovane | Sanofi | 7.5 mg Tablet | $50 (30 tablets) |
Zimovane | Teva | 7.5 mg Tablet | $40 (30 tablets) |
Generic Zopiclone | Various | 7.5 mg Tablet | $15 (30 tablets) |
18. 15 FAQs (Frequently Asked Questions)
1. What is Zopiclone used for?
Zopiclone is used to treat short-term insomnia, helping with sleep onset and maintenance.
2. How does Zopiclone work?
It enhances the action of GABA, a neurotransmitter that promotes sedation and sleep.
3. Can Zopiclone cause dependence?
Yes, long-term use or misuse may lead to physical and psychological dependence.
4. Is Zopiclone safe for elderly patients?
Yes, but at a reduced dose of 3.75 mg to minimise sedation, cognitive impairment, and fall risk.
5. How long does Zopiclone take to work?
It typically works within 30 minutes of ingestion.
6. Can I drink alcohol while taking Zopiclone?
No, alcohol enhances the sedative effects and increases the risk of side effects.
7. Can Zopiclone cause memory problems?
Yes, it may cause anterograde amnesia (difficulty forming new memories) in some cases.
8. Is Zopiclone addictive?
Yes, prolonged use or misuse may lead to addiction and withdrawal symptoms.
9. How should Zopiclone be stored?
Store at room temperature, away from moisture and heat, and out of reach of children.
10. Can Zopiclone cause sleepwalking?
Yes, rare cases of complex sleep behaviours like sleepwalking or sleep-driving have been reported.
11. How long can Zopiclone be used?
It is typically prescribed for short-term use, not exceeding 4 weeks.
12. Can Zopiclone be used in pregnancy?
Use only if necessary and under medical supervision, as it may affect the foetus.
13. Can I stop taking Zopiclone suddenly?
No, abrupt discontinuation may cause withdrawal symptoms. Taper the dose gradually if needed.
14. Does Zopiclone affect driving?
Yes, it can impair driving and other activities requiring alertness, even the day after use.
15. Can Zopiclone be taken with food?
It can be taken with or without food, but a high-fat meal may delay its onset of action.