Can You Take Zopiclone with Pregabalin?
A plain-English look at the major interaction between Zopiclone (Imovane) and Pregabalin (Lyzalon) — what it means, why it happens, and what to talk to your doctor or pharmacist about.
Taking Zopiclone (Imovane) with Pregabalin (Lyzalon) is a major drug interaction that should be avoided. Respiratory depression, excessive sedation, overdose. Additive CNS depression. Gabapentinoids potentiate opioid-induced respiratory depression even at therapeutic doses.
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Key Takeaways
- Interaction severity: Major
- Risk: Respiratory depression, excessive sedation, overdose.
- Mechanism: Additive CNS depression. Gabapentinoids potentiate opioid-induced respiratory depression even at therapeutic doses.
- Zopiclone: S4 in Australia, moderate risk
- Pregabalin: S4 in Australia, moderate risk
- Claims action: Flag for immediate prescriber review. Document intervention in claim file.
Zopiclone vs Pregabalin at a Glance
| Property | Zopiclone | Pregabalin |
|---|---|---|
| Brand names | Imovane, Imoclone, APO-Zopiclone | Lyzalon, Pregabalin Sandoz, APO-Pregabalin |
| Drug class | opioid | gabapentinoid |
| Risk level | moderate | moderate |
| TGA Schedule (AU) | S4 | S4 |
Why Is This Combination Dangerous?
Additive CNS depression. Gabapentinoids potentiate opioid-induced respiratory depression even at therapeutic doses.
Regulatory Guidance by Jurisdiction
Australia TGA / SIRA / WorkSafe
The TGA and Australian Medicines Handbook classify this as a major drug interaction requiring immediate intervention.
The TGA has issued safety communications about the risk of respiratory depression when gabapentinoids are combined with opioids. WorkSafe Victoria Drugs of Dependence Guidelines require monitoring for this combination.
United Kingdom NICE / MHRA / FPM
The MHRA has issued Drug Safety Updates warning about the risk of respiratory depression and death when gabapentinoids are combined with opioids. NICE CG173 (Neuropathic Pain) recommends gabapentinoids as monotherapy, not in combination with opioids.
United States FDA / CDC / State WC
The FDA has added warnings to gabapentinoid labels about serious breathing difficulties when taken with opioids. The CDC opioid guidelines recommend caution with concurrent CNS depressant use. Some state formularies require prior authorization for this combination.
What Claims Professionals Should Do
- Flag immediately as a high-risk prescribing pattern in the claim file
- Request urgent prescriber review with documented clinical justification for the combination
- Consider an independent medical examination if the prescriber cannot provide adequate justification
- Assess work capacity impact as the combination significantly increases sedation and impairment risk
- Document all interventions for audit trail and compliance purposes
- Check Reasonable and Necessary status for both medications against the compensable injury
Clinical reference
A clinical summary of Zopiclone and Pregabalin drawn from regulator advisories, national guidelines, and authoritative drug references. Read this if you want the deeper clinical picture before talking to your prescriber or pharmacist.
Severity assessment
Major. The combination of pregabalin and zopiclone significantly increases the risk of severe central nervous system (CNS) depression, including profound sedation, respiratory depression, and coma.
Mechanism (plain English)
Both pregabalin and zopiclone are medicines that act on the brain to slow down its activity. Pregabalin works by calming overactive nerve signals, which can reduce pain or seizures. Zopiclone is a sleeping tablet that enhances the effects of a natural brain chemical called GABA, which helps to reduce brain activity and promote sleep. When taken together, their combined effects on the brain are additive, leading to a much greater slowing of brain function than either drug would cause alone. This can result in excessive drowsiness, reduced alertness, and dangerously slow or shallow breathing.
Evidence level
Guideline-supported. The British National Formulary (BNF), a key UK clinical guideline, explicitly highlights the interaction between pregabalin and zopiclone due to their additive CNS depressant effects [1, 2]. The FDA has also issued warnings regarding the co-administration of pregabalin with other CNS depressants, including sedatives/hypnotics, due to the increased risk of respiratory depression [3].
Top regulator advisories
- TGA (Australia): No specific public advisory found for the pregabalin + zopiclone pair. However, the TGA has reminded health professionals about the careful prescribing of zopiclone to minimize risks, and general warnings apply to gabapentinoids (which include pregabalin) regarding CNS depression when combined with other CNS depressants. [4, 5]
- MHRA / NICE (UK): The British National Formulary (BNF), published by NICE, states that both pregabalin and zopiclone have additive CNS effects and can cause sedation, which may affect the ability to perform skilled tasks. It advises caution with concomitant use. [1, 2]
- FDA / CDC (US): The FDA has issued warnings regarding the co-administration of pregabalin with other CNS depressants, including sedatives/hypnotics, due to the increased risk of respiratory depression. [3]
- EMA (Europe): No specific EMA advisory found for the pregabalin + zopiclone pair. General warnings regarding CNS depression with concomitant use of CNS depressants are typically included in product information for both drugs.
Clinical risk factors that elevate the danger
- Concomitant use of other CNS depressants: Including alcohol, opioids, benzodiazepines, or other sedatives/hypnotics, which further amplify CNS depression and respiratory risk.
- Elderly patients: Increased sensitivity to CNS depressant effects and reduced drug clearance.
- Patients with respiratory compromise: Conditions such as chronic obstructive pulmonary disease (COPD), sleep apnea, or asthma, which predispose to respiratory depression.
- Patients with a history of substance abuse: Higher likelihood of intentional misuse or overdose.
- High doses of either medication: Dose-dependent increase in CNS depressant effects.
What a patient should be told
- Risk: Taking pregabalin and zopiclone together can make you very drowsy, dizzy, confused, and can dangerously slow down your breathing. This can be life-threatening.
- Do not stop suddenly: If you are currently taking both, do not stop either medication suddenly without talking to your doctor or pharmacist first, as this can cause withdrawal symptoms.
- Warning signs: Seek immediate medical attention if you experience extreme sleepiness, difficulty waking up, very slow or shallow breathing, or if you feel faint or unresponsive.
- Safer alternatives: Discuss with your doctor or pharmacist if there are safer alternative treatments or adjustments to your current medications.
- Urgent care triggers: Call emergency services immediately if you or someone you know shows signs of severe breathing problems or unresponsiveness after taking these medications.
Top 3 sources (with full citation)
- Pregabalin | Interactions | BNF - NICE. NICE. Available at: https://bnf.nice.org.uk/interactions/pregabalin/ (Accessed: June 1, 2026).
- Zopiclone | Interactions | BNF - NICE. NICE. Available at: https://bnf.nice.org.uk/interactions/zopiclone/ (Accessed: June 1, 2026).
- FDA Drug Safety Communication: FDA warns about serious breathing problems with gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) in patients with respiratory risk factors. U.S. Food and Drug Administration. (2019). Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-gabapentin-neurontin-gralise-horizant-and-pregabalin (Accessed: June 1, 2026).
- Zopiclone | Drugs - BNF - NICE. NICE. (This entry mentions MHRA/CHM advice regarding Z-drugs). Available at: https://bnf.nice.org.uk/drugs/zopiclone/ (Accessed: June 1, 2026).
- Gabapentinoids: a therapeutic review. Athavale, A., Murnion, B. Australian Prescriber. (2023). Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10751078/ (Accessed: June 1, 2026).
Notes for the reviewing pharmacist
This interaction is well-documented due to the additive CNS depressant effects of both drugs. While specific TGA advisories for the pair may not be readily available, the general warnings for gabapentinoids and Z-drugs regarding co-administration with other CNS depressants are highly relevant. Misconceptions may arise from patients not understanding the cumulative effect of CNS depressants, especially if they are prescribed by different practitioners or if alcohol is also consumed. There is also a known potential for abuse and misuse of both pregabalin and zopiclone, which is significantly heightened when used in combination. Careful patient education, monitoring for signs of respiratory depression and sedation, and consideration of alternative therapies or dose adjustments are crucial, particularly in vulnerable populations such as the elderly or those with pre-existing respiratory conditions. The MHRA/CHM advice regarding Z-drugs and gabapentinoids (mentioned in the Zopiclone BNF entry) further underscores the regulatory concern around these drug classes.
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Related Resources
Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.