Leaflet IMOVANE 7.5mg film-coated tablets

Product code:
W64484002
Quantity:
14
Indicated for:
insomnia
Route of administration:
oral
Substance:
zopiclone (sedative-hypnotic)
ATC
N05CF01 — Nervous system | Hypnotics and sedatives | Benzodiazepine related drugs

Precautions:

Driving impairment

Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo

Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Dependence / abuse

Dependence / abuse

This medicine may cause dependence or be misused.

Respiratory depression

Respiratory depression

May slow breathing, especially with alcohol or sedatives.

Avoid alcohol

Avoid alcohol

Avoid alcohol during treatment.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning

Elderly warning

Older people may have an increased risk of side effects.

Withdrawal / do not stop abruptly

Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation

Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Zopiclone is a hypnotic medication used for the short-term treatment of insomnia. It belongs to the class of drugs known as z-drugs and works by binding to GABA-A receptors in the brain, inducing a sedative effect and promoting sleep. It is indicated for patients who have difficulty falling asleep, wake up frequently during the night, or wake up too early in the morning.

Zopiclone is effective in reducing sleep latency (the time it takes to fall asleep) and increasing total sleep duration. It is recommended for short-term use, typically for a period of up to 2-4 weeks, to avoid the risk of dependence or tolerance.

Common side effects include a metallic or bitter taste, dry mouth, daytime drowsiness, dizziness, and, in rare cases, complex sleep-related behaviors such as sleepwalking or eating during sleep. Prolonged use may lead to dependence, and abrupt discontinuation can cause withdrawal symptoms such as rebound insomnia or anxiety.

Zopiclone should be taken as directed by a doctor, usually before bedtime, and should not be combined with alcohol or other sedatives. Patients should avoid activities requiring alertness, such as driving, until the effects of the medication have worn off.
IMOVANE 7.5mg film-coated tablets SANOFI, zopiclone

General data about IMOVANE 7.5mg

Substance:
zopiclone
Date of latest medicines list:
01-06-2026
Product code:
W64484002
Concentration:
7.5mg
Pharmaceutical form:
film-coated tablets
Quantity:
14
Product type:
Original
Price:
35.82 RON
Prescription status:
TAB3 — Medicines dispensed with a special medical prescription for psychotropic substances, green in color.

Marketing authorisation

Manufacturer:
OPELLA HEALTHCARE INTERNATIONAL SAS - FRANTA
Holder:
SANOFI ROMANIA S.R.L. - ROMANIA
Number:
8632/2016/02
Shelf life:
3 years

Concentrations available for zopiclone

  • 3.75mg
  • 5mg
  • 7.5mg

Compensation lists for IMOVANE 7.5mg Sanofi

A - Sublist A with 90% discount from the reference price

Price
35.82 RON
Copayment
11.97 RON
Patient
23.85 RON