Nottem: detailed information

Package leaflet: Information for the patient

Nottem 10 mg film-coated tablets

zolpidem tartrate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Nottem is and what it is used for
What you need to know before taking Nottem
How to take Nottem
Possible side effects
How to store Nottem
Contents of the pack and other information

1. What Nottem is and what it is used for

Nottem contains zolpidem tartrate, which belongs to a class of medicines called
"benzodiazepine-like drugs".
Nottem is indicated for the short-term treatment of sleep disorders (insomnia) in adults, only in cases where the sleep disturbances are severe, disabling or causing marked distress.
It must not be used for long periods. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.

2. What you should know before taking Nottem

Do not take Nottem

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
if you suffer from a disease causing severe muscle weakness (myasthenia gravis),
if you have difficulty breathing (acute and/or severe respiratory failure),
if you suffer from brief episodes of breathing interruption during sleep (sleep apnoea syndrome),
if you have severe liver damage (severe hepatic insufficiency),
if you are a child or adolescent under 18 years of age,
if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding"),
if you have previously experienced episodes of sleepwalking or other unusual behaviours during sleep while not fully awake, after taking Nottem or other medicines containing zolpidem (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before taking Nottem.
Before prescribing Nottem, your doctor should try to identify and treat the underlying causes of your sleep disorders.
If your sleep problems do not improve after 7–14 days of treatment, there may be an underlying psychiatric or physical condition that needs to be investigated.

Next-day psychomotor impairment (see also “Driving and use of machines”)
Nottem, like other medicines used to treat anxiety and/or insomnia, has central nervous system depressant effects.
On the day following intake of Nottem, the risk of psychomotor impairment, including impaired ability to drive, may increase if you:

take this medicine less than 8 hours before performing activities requiring mental alertness,
take a higher dose than recommended,
take zolpidem together with other medicines that depress the central nervous system, other medicines that increase zolpidem levels in the blood, alcohol, or illicit psychoactive substances.
Take a single dose immediately at bedtime. Do not take another dose during the same night.

Tolerance:
After repeated use for several weeks, a certain reduction in the effect of this medicine may occur.

Dependence:
Use of Nottem may lead to abuse and/or physical and psychological dependence (need to continue taking the medicine). Inform your doctor if you have ever had mental health disorders, or have abused or been dependent on alcohol, drugs, or medicines.
The risk of dependence is higher when zolpidem is used for more than 4 weeks. The risk of dependence increases with higher doses and longer duration of treatment. The risk of abuse and dependence is greater in patients with a history of mental health disorders and/or abuse of alcohol, illicit substances, or medicines.
If you have developed physical dependence, abruptly stopping treatment may cause withdrawal symptoms such as:

headache,
muscle pain,
extreme anxiety,
tension,
restlessness,
confusion,
irritability.
In severe cases, the following symptoms may occur:
feeling detached from reality (derealisation),
feeling detached from one's own body (depersonalisation),
hearing disturbances (hyperacusis),
numbness and tingling in the extremities,
hypersensitivity to light, noise, and physical contact,
hallucinations,
epileptic seizures.

Rebound insomnia
When stopping the medicine, a transient syndrome may occur, consisting of a return of the original sleep problems, often in a more severe form. This may be accompanied by other reactions such as mood changes, anxiety, restlessness, or sleep disturbances.
This syndrome is more likely to occur if the medicine is stopped abruptly; therefore, stop treatment with Nottem gradually.
It is important that you are aware of the possibility of such symptoms occurring, to help reduce your anxiety.

Duration of treatment
The duration of treatment should be as short as possible (see “How to take Nottem”) and should not exceed 4 weeks, including the tapering-off phase.
The treatment should not be prolonged beyond this period unless your doctor has reassessed your condition.
Initially, your doctor will explain that this treatment will be of limited duration and how you should gradually reduce the dose.

Memory disturbances (amnesia):
Nottem may cause memory disturbances (anterograde amnesia). This effect most often occurs several hours after taking the medicine.
To reduce the risk, ensure you can sleep uninterrupted for 8 hours (see “Possible side effects”).

Other psychiatric reactions and “paradoxical” reactions:
During use of benzodiazepines or medicines similar to Nottem, the following may occur:

restlessness,
worsening of insomnia,
agitation,
irritability,
aggression,
delirium,
anger,
nightmares,
hallucinations,
mental disorders (psychosis),
inappropriate behaviour.

If any of these occur, contact your doctor and stop taking Nottem.
These reactions are more likely to occur in children and elderly patients.

Sleep disorders (sleepwalking) and associated behaviours:
Nottem may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or having sexual intercourse) while not fully awake. The next morning, you may not remember what you did during the night. If any of the above conditions occur, stop treatment with Nottem immediately and contact your doctor, as these sleep-related behaviours may seriously endanger you or others (see “Do not take Nottem”).
Both drinking alcohol or taking other medicines that cause drowsiness together with Nottem, and using Nottem at doses exceeding the maximum recommended dose, increase the risk of these sleep-related behaviours occurring (see “Nottem with alcohol” and “Possible side effects”).

Serious injuries:
Nottem may cause drowsiness and reduced level of consciousness, which may lead to falls and consequently to serious injuries.

Elderly patients:
If you are elderly, your doctor will prescribe a lower dose (see “How to take Nottem”).

Patients with respiratory problems:
If you suffer from severe respiratory problems (chronic respiratory insufficiency), your doctor will prescribe Nottem cautiously, as it may depress respiratory function (see “Possible side effects”).

Patients with liver problems:
If you suffer from severe liver problems (severe acute or chronic hepatic insufficiency), Nottem is not recommended, as it may worsen brain damage (encephalopathy) (see “Do not take Nottem”, “How to take Nottem”, and “Possible side effects”).

Patients with psychotic disorders:
Nottem is not recommended as primary treatment for psychotic disorders.

Patients with depression or anxiety associated with depression:
Nottem should not be used alone to treat depression or anxiety associated with depression, as suicidal tendencies may increase.
Nottem, like other benzodiazepines and similar substances, should be administered with caution if you have depression or anxiety associated with depression.
If you are depressed, you may have suicidal tendencies, and therefore your doctor will prescribe the smallest possible amount of medicine: in this regard, it is recommended that you strictly follow your doctor’s instructions.
Pre-existing depression may become apparent during use of Nottem. Since insomnia may be a symptom of depression, your doctor will reassess your case if insomnia persists.

Possibility of suicide
Several studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or whether there may be another reason. If you have suicidal thoughts, contact your doctor as soon as possible for further evaluation.

Patients with a history of alcohol or drug abuse:
Nottem should be used with caution if you have previously abused alcohol or drugs.

Patients with long QT syndrome:
If you have a congenital condition called long QT syndrome, your doctor must carefully assess whether you can take zolpidem.

Children and adolescents
Nottem must not be used in children and adolescents under 18 years of age (see “Do not take Nottem”).

Other medicines and Nottem
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When taking zolpidem together with the following medicines, increased effects such as drowsiness and next-day psychomotor impairment, including impaired ability to drive, may occur (see “Driving and use of machines”):

medicines for certain mental health conditions (antipsychotics),
medicines for insomnia (hypnotics),
medicines to calm or reduce anxiety,
medicines for depression,
medicines for moderate to severe pain (narcotic analgesics),
medicines for epilepsy,
medicines used in anaesthesia,
medicines for hay fever, skin rashes (rash), or other allergies that may cause drowsiness (sedating antihistamines).

While taking zolpidem with antidepressant medicines, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
The effects of Nottem may also be influenced by, or may influence, the following medicines:

highly effective painkillers (narcotic analgesics), as an increased sense of euphoria may occur, which could lead to increased dependence (need to continue taking the medicine);
inhibitors and inducers of a liver protein (cytochrome CYP450), as substances that inhibit this protein may increase the activity of benzodiazepines or similar substances like Nottem;
rifampicin (an antibiotic), as the effect of Nottem decreases when taken with this medicine;
St. John’s wort, as the effect of Nottem decreases when taken with this herbal remedy;
itraconazole (for fungal infections); the effect of Nottem is not affected by this medicine;
ketoconazole (for fungal infections), as concomitant administration of Nottem and ketoconazole (200 mg twice daily) may increase the sedative effects of Nottem.

Other medicines

The use of Nottem together with opioids (strong painkillers, drugs for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Nottem together with opioids, your doctor will limit the dose and duration of concomitant treatment. Inform your doctor if you are taking opioid medicines and follow your doctor’s dosage instructions carefully. It may be helpful to inform family and friends so they are aware of the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
No significant interactions have been observed when Nottem is taken together with warfarin (to reduce blood clotting), digoxin (for treatment of heart failure), or ranitidine (for stomach problems).

Nottem with alcohol
Do not take Nottem with alcohol, as the calming (sedative) effect may be increased when the medicine is taken with alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Nottem must not be taken during pregnancy (see “Do not take Nottem”).
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor.
There is a risk to the unborn baby if Nottem is used during pregnancy. Some studies have shown an increased risk of cleft palate (sometimes called “hare lip”) in the newborn.
Reduced fetal movement and reduced variability in fetal heart rate may occur after taking Nottem during the second and/or third trimester of pregnancy.
If, for absolute medical necessity, Nottem must be administered at the end of pregnancy or during childbirth, the baby may show:

muscle weakness,
low body temperature,
feeding difficulties,
breathing problems (respiratory depression).

If this medicine is taken regularly in the late stages of pregnancy, the baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as restlessness or tremors. In this case, the newborn must be closely monitored during the postnatal period.
Severe respiratory depression may occur in the newborn if Nottem is used together with other central nervous system depressant medicines towards the end of pregnancy.

Breastfeeding
Nottem passes into breast milk and therefore must not be taken during breastfeeding (see “Do not take Nottem”).

Driving and use of machines
Nottem impairs your ability to drive vehicles and operate machinery, with a risk, for example, of "falling asleep at the wheel".
On the day following intake of Nottem (as with other hypnotic medicines), you should be aware that:

you may feel drowsy, sleepy, dizzy, or confused,
you may take longer to make decisions,
your vision may be blurred or double,
you may feel less alert.

A minimum interval of 8 hours is recommended between taking zolpidem and driving, operating machinery, or working at heights, to minimise the effects listed above. Do not drink alcohol or take other psychoactive substances while taking Nottem, as the effects listed above may be intensified.

Nottem contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

Nottem contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Nottem

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment should be as short as possible.
Generally, this duration ranges from a few days to two weeks, with a maximum of four weeks including the medicine's withdrawal phase.
Sometimes your doctor may extend the maximum treatment period; in such cases, follow your doctor's instructions carefully.
The recommended dose is 10 mg (1 tablet) of Nottem per day. Do not exceed the dose of 10 mg every 24 hours.
A lower dose may be prescribed for certain patients:

Use in elderly or debilitated patients
If you are elderly or debilitated, you may be particularly sensitive to the effects of Nottem; the recommended dose is:
half a tablet (5 mg), which will be exceeded only in exceptional cases.

Use in patients with liver problems (hepatic insufficiency) who do not eliminate the medicine as rapidly as normal subjects
the recommended dose is:
half a tablet (5 mg), which will be exceeded only in exceptional cases.

Nottem should be taken:

as a single administration,
just before going to bed. Make sure you have at least an 8-hour period after taking this medicine before carrying out activities requiring your alertness. Do not take another dose of Nottem during the same night.

Use in children and adolescents
Nottem must not be used in children and adolescents under 18 years of age (see "Do not take Nottem").

If you take more Nottem than you should
In case of accidental ingestion/overdose of Nottem, contact your doctor immediately or go to the nearest hospital.
In cases of overdose (overdosing) of Nottem, either alone or in combination with other medicines or substances that depress the activity of the Central Nervous System (including alcohol), the following have been reported:

a reduced level of consciousness up to coma;
severe disturbances that may lead to death.

If you forget to take Nottem
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
With Nottem, dose-dependent side effects may occur, particularly affecting the Central Nervous System (CNS).
These effects:

are less pronounced if you take Nottem immediately before going to bed or while already lying down,
occur more frequently if you are elderly.

Common side effects (may affect up to 1 in 10 people)

drowsiness,
headache,
dizziness,
increased insomnia,
cognitive disturbances such as memory loss (anterograde amnesia), which may be associated with inappropriate behavior,
hallucinations,
agitation,
nightmares,
depression (see “Warnings and precautions”),
fatigue,
vision problems (impaired vision),
diarrhea,
nausea,
vomiting,
abdominal pain,
back pain,
respiratory tract infection (upper and lower).

Uncommon side effects (may affect up to 1 in 100 people)

altered sensation in parts of the body (paraesthesia),
tremor,
attention and language disturbances,
confusion,
irritability,
restlessness,
aggression,
sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or having sexual intercourse) while not fully awake (see “Do not take Nottem” and “Warnings and precautions”),
euphoria,
double vision (diplopia),
blurred vision,
joint pain (arthralgia),
muscle pain (myalgia),
involuntary muscle contractions (muscle spasms),
neck pain,
muscle weakness,
skin irritations (rash),
itching,
excessive sweating (hyperhidrosis),
increased levels in liver blood tests,
appetite disturbances.

Rare side effects (may affect up to 1 in 1,000 people)

decreased level of consciousness,
changes in sexual desire,
changes in gait,
falls (especially in elderly patients and when Nottem is not taken as prescribed) (see “Warnings and precautions”),
urticaria,
liver damage and bile flow impairment (hepatocellular, cholestatic, and mixed liver injury) (see “Do not take Nottem”, “Warnings and precautions”, and “How to take Nottem”).

Very rare side effects (may affect up to 1 in 10,000 people)

delirium,
dependence (after discontinuation of treatment, withdrawal syndrome or rebound effects may occur. See “Warnings and precautions”),
respiratory depression (see “Warnings and precautions”).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

anger,
abnormal behavior,
delirium (a sudden and severe change in mental status causing confusion or disorientation),
loss of response to the medicine (tolerance),
swelling of the face, throat, or limbs, possibly with breathing difficulty (angioedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nottem

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nottem contains

The active substance is zolpidem tartrate. One film-coated tablet contains 10 mg of zolpidem tartrate.
The other ingredients are: lactose monohydrate; microcrystalline cellulose; hypromellose; sodium carboxymethyl starch (type A); magnesium stearate. Tablet coating: hypromellose; titanium dioxide (E171); macrogol 400.

Description of the appearance of Nottem and contents of the pack
Nottem is available as:
Film-coated tablets.

Pack of 7 film-coated tablets of 10 mg
Pack of 30 film-coated tablets of 10 mg.

Marketing Authorization Holder
Sanofi S.r.l. – Viale L. Bodio, 37/B – Milan
Manufacturer
Delpharm Dijon - 6, Boulevard de l’Europe - Quetigny, France