Zerene - zaleplon

What is Zerene?

Zerene is a medicine that contains the active substance zaleplon. It is available in capsules (white and brown: 5 mg; white: 10 mg).

What is Zerene used for?

Zerene is indicated for the treatment of adults with insomnia who have difficulty falling asleep. it is prescribed only when the disorder is severe, debilitating or due to extremely serious problems.

The medicine can only be obtained with a prescription.

How is Zerene used?

Treatment with Zerene should be as short as possible and should not last more than two weeks.

Zerene should be taken immediately before bedtime, or later if the patient has difficulty falling asleep. The recommended dose is 10 mg, but in the case of elderly patients or those with light or moderate liver problems, it should be reduced to 5 mg.

The total daily dose of Zerene should not exceed 10 mg. Do not take a second dose on the same night. You should not eat anything during or shortly before taking Zerene, because food may reduce the effect of the medicine. Zerene should not be taken by children or patients who have severe problems with their liver or kidneys. For more information, see the package leaflet.

How does Zerene work?

The active substance in Zerene, zaleplon, belongs to a class of medicines associated with benzodiazepines. Zalepon is chemically different from benzodiazepines, but acts on the same receptors in the brain. It is an agonist of the gamma-aminobutyric acid receptor (GABA), which means that it binds to the receptors of the neurotransmitter GABA and activates them. Neurotransmitters, such as GABA, are chemicals that allow nerve cells to communicate with each other. In the brain, GABA helps induce sleep. By activating its receptors, zaleplon increases the effect of GABA, which promotes sleep.

The powder contained in the Zerene capsules is colored with a very intense blue dye to prevent the drug from being accidentally given to someone.

What studies have been carried out on Zerene?

Zerene has been examined in a total of 14 studies, involving approximately 3, 500 adult and elderly patients. Five of these studies were comparative: Zerene was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other drugs used to treat insomnia). The main studies lasted between two and four weeks. The main measure of effectiveness was the time needed to fall asleep. Time spent sleeping and sleep characteristics were also observed in some studies.

What benefit has Zerene shown during the studies?

The time needed to fall asleep was shorter in adults treated with Zerene 10 mg and the effects lasted up to four weeks.

In elderly patients, the time necessary to fall asleep has often decreased with Zerene 5 mg and has always decreased with Zerene 10 mg compared to placebo, in studies lasting two weeks. Zerene 10 mg proved more effective than placebo in decreasing the time needed to fall asleep and increasing the duration of sleep during the first half of the night.

In studies in which the duration of the various phases of sleep was measured, Zerene did not alter sleep characteristics.

What is the risk associated with Zerene?

The most frequent side effects with Zerene (seen in 1-10 patients in 100) are amnesia (memory loss), paresthesia (unusual sensations, such as tingling), drowsiness and dysmenorrhea (painful menstruation). For the full list of all side effects reported with Zerene, see the Package Leaflet.

Zerene should not be used in people who may be hypersensitive (allergic) to zaleplon or any of the other ingredients. It must not be used in patients with severe liver or kidney problems, sleep apnea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease that causes muscle weakness) or severe respiratory insufficiency (breathing disorders) nor in patients under the age of 18.

Why has Zerene been approved?

The Committee for Medicinal Products for Human Use (CHMP) has decided that the benefits of Zerene outweigh its risks in the treatment of patients suffering from insomnia who have difficulty falling asleep, when the disorder is severe, debilitating or due to extremely serious problems. The Committee recommended that Zerene be given marketing authorization.

More information on Zerene:

On 12 March 1999, the European Commission issued a marketing authorization for Zerene, valid throughout the European Union. The marketing authorization was renewed on 12 March 2004 and 12 March 2009. The marketing authorization holder is Meda AB.

The full EPAR for Zerene can be found here.

Last update of this summary: 03-2009.