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Zopiclone: Effects, Evidence and Risks

Also known as Ximovan, Zimovane, Imovane, generic zopiclone, Z-drug.

StatusApproved (EU)
EvidenceLarge RCTs
Drug classHypnotic (Z-drug, GABA-A modulator) · tablets
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What is Zopiclone?

Zopiclone is a sleeping pill from the group of so-called Z-drugs. Like benzodiazepines, it enhances the effect of the inhibitory neurotransmitter GABA at the GABA-A receptor and has sleep-inducing, calming and muscle-relaxing effects.

How well studied is Zopiclone?

Efficacy for the short-term treatment of insomnia is established by registration trials. There is no proof of efficacy for long-term use, but there is evidence of tolerance and dependence.

What side effects and risks does Zopiclone have?

Common effects are a bitter taste, dry mouth and next-day drowsiness with impaired driving ability. Dependence can develop even with short-term use; stopping can cause rebound insomnia, restlessness and withdrawal symptoms. Complex sleep behaviours (sleepwalking, sleep-driving) with memory gaps have been reported. Combined with alcohol or opioids it can cause respiratory depression, coma and death; older people have a higher risk of falls.

Is Zopiclone approved in Germany?

In short: yes. Approved as a medicine in Germany and prescription-only, intended for short-term treatment only. To our knowledge zopiclone is listed as a substance under the German Narcotics Act (BtMG, Schedule III), but standard tablets are exempt preparations that can be prescribed on a normal prescription. Not on the WADA Prohibited List; taking it without a doctor is dangerous because of the dependence risk.

Sources

Note: We deliberately do not list any doses here. For approved medicines, your doctor sets the dose; for unapproved substances there is no reliable information.