5 mg and 10 mg film-coated tablets
zolpidem tartrate
What Stilnoct is and what it is used for
Stilnoct contains zolpidem, which is a fast-acting sleep aid belonging to the group of benzodiazepine-related drugs. The time you sleep becomes longer and the risk of you waking up during the night decreases.
Stilnoc is used for the short-term treatment of insomnia in adults. Do not use it for a long time. The treatment should be as short as possible because the risk of addiction increases with the length of the treatment.
What you need to know before using Stilnoct
Do not use Stilnoct
- if you are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6)
- if you have severely impaired liver function
- if you have severe breathing problems
- if you have temporary pauses in breathing when you sleep ( sleep apnea )
- if you suffer from the muscle disease myasthenia gravis (severe muscle weakness)
- if you have ever sleepwalked or experienced other unusual behaviors during sleep that you performed without being fully awake (such as driving, eating, making a phone call, having sex, etc.) after taking Stilnoc or other medicines containing zolpidem.
Warnings and precautions
Talk to your doctor or pharmacist before using Stilnoct.
Tell the doctor about:
- you have reduced kidney function.
- you have reduced liver function.
- you have chronic respiratory problems.
- you have or have had a mental illness.
- you suffer from depression or have suicidal thoughts.
- you abuse or have abused alcohol, drugs, or medicines.
Treatment with sleeping pills should be temporary. Contact your doctor if your sleep problems persist after 7-14 days of treatment. The sleeping problems may then have other causes.
Tolerance
After repeated use for a few weeks, the sleep-inducing effect may decrease.
Dependent
Use of Stilnoct can lead to abuse and physical and psychological dependence on the drug. The risk of developing dependence is greater when Stilnoct is used for longer periods than 4 weeks, and in patients who have previously had mental illnesses and/or alcohol, medication, or drug abuse.
Release ( rebound effect )
When treatment with a sleeping aid ends, a transient syndrome may occur, where the sleep disturbances return in an aggravated form. It may be accompanied by other reactions such as mood changes, anxiety, and restlessness.
Memory disorders ( amnesia )
Memory disturbances may occur. These usually occur several hours after you take the medicine. To reduce the risk, you must ensure that you sleep undisturbed for 8 hours.
Psychic and “paradoxical” reactions
Reactions such as restlessness, worsening insomnia, agitation, irritability, aggressiveness, delusions, tantrums, nightmares, hallucinations, inappropriate behavior,
delirium (a sudden and severe change in a mental state that makes a person appear confused or disoriented), sleepwalking, or other behavioral disturbances may occur during treatment. If this occurs, treatment with Stilnoct must be discontinued. These reactions occur more often in the elderly.
Sleepwalking and similar behaviors
Using Stilnoct may cause you to sleepwalk. It can also cause other behaviors that are unusual during sleep that you perform without being fully awake (such as driving, eating, making phone calls or having sex, etc.). The next morning, you may not remember that you did anything during the night. If you experience any of the above, stop treatment with Stilnoct immediately and contact your doctor as these sleep behaviors can pose a serious risk of injury to you and other people.
Drinking alcohol or taking other drugs that make you drowsy/sleepy along with Stilnoct can increase the risk of these sleep behaviors occurring.
Risk of falling
Because Stilnoct i.a. can cause drowsiness, increases the risk of falls and thus serious injuries (see section 4).
Problems with coordination the following day (see also Driving ability and use of machines).
The day after taking Stilnoct, the risk of coordination problems, including impaired driving ability, may be greater if:
- you take this medicine less than 8 hours before performing activities that require alertness
- you are taking a higher dose than recommended
- you take zolpidem at the same time as you take other sedatives that affect the functioning of the central nervous system, other medicines that increase zolpidem in the blood, drink alcohol, or use illegal drugs.
Suicidal ideation, suicide attempt, and suicide
Some studies have shown an increased risk of suicidal ideation, suicide attempt, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is due to the drug treatment or whether it may have other causes. If you are having suicidal thoughts, contact your doctor for medical advice as soon as possible.
Children and young people
Children and young people under the age of 18 should not use Stilnoct, as there is no information on such use.
Other medicines and Stilnoct
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The risk of drowsiness and problems with coordination the next day, including impaired ability to drive, may increase when you take zolpidem at the same time as the following type of medicine:
- Medicines for certain mental problems (antipsychotics)
- Medicines for sleep problems ( hypnotics )
- Medicines that suppress or reduce anxiety
- Medicines for depression
- Medicines for moderate or severe pain (narcotic analgesics )
- Medicines for epilepsy
- Medicines used in anesthesia
- Medicines for hay fever, rashes, or other allergies that can make you sleepy (some antihistamines )
If you take zolpidem at the same time as antidepressants such as bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).
Simultaneous use of Stilnoct and opioid medicines (strong painkillers, medicines for the treatment of patients who have become addicted to opioids, and certain cough medicines) increases the risk of drowsiness, breathing difficulties ( respiratory depression ), coma, and can be life-threatening. Because of this, concomitant use should only be considered by the physician when other treatment options are not possible. If the doctor prescribes Stilnoct simultaneously with opioid drugs, the dose and duration of treatment should be limited by the doctor.
Tell your doctor if you are taking any opioid medication and follow your doctor’s dosage recommendations carefully. It may be good to inform friends or relatives about the risks described above. Contact a doctor if you experience any of these symptoms.
You are not recommended to take zolpidem together with fluvoxamine or ciprofloxacin.
The treatment effect can be affected if you take Stilnoct together with medicines containing rifampicin (for tuberculosis) or certain medicines for fungal infections ( ketoconazole ).
The treatment effect can be affected if Stilnoct is taken together with St. John’s wort.
Still night with alcohol
Avoid alcohol when taking Stilnoct, as the sedative effect of the medicine may be enhanced.
Pregnancy and breastfeeding
Pregnancy
Use of Stilnoct during pregnancy is not recommended. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult a doctor for advice.
There is a risk that the baby will be affected if Stilnoct is used during pregnancy. Some studies have shown that there may be an increased risk of cleft lip and palate in newborns. Reduced fetal movements and effects on the fetal heart rate may occur after taking Stilnoc during the last six months of pregnancy.
If Stilnoct is taken at the end of pregnancy or during childbirth, the newborn baby may have the following symptoms: muscle weakness, low body temperature, difficulty eating, and breathing problems ( respiratory depression ).
With regular use late in pregnancy, the child may develop physical dependence and run the risk of developing withdrawal symptoms such as restlessness and tremors after birth. In this case, the child must be followed up closely by a doctor during the first months after birth.
Breast-feeding
Small amounts of zolpidem pass into breast milk. Stilnoc should therefore not be used during breastfeeding. If you are breastfeeding, consult a doctor for advice.
Driving ability and use of machinery
Stilnoct has a major impact on your ability to drive and use machines, for example so-called “sleep-driving”. The day after you take Stilnoct (as with other medicines for sleep problems), you should be aware that:
- You may feel drowsy, sleepy, dizzy, or confused
- It takes longer for you to make a quick decision
- You may see blurred or double vision
- You can be less attentive
A period of at least 8 hours is recommended between taking zolpidem and driving, using machinery, or working at high altitudes to minimize the effects mentioned above.
Do not drink alcohol or take other psychoactive substances while taking Stilnoct, as this may increase the effects mentioned above.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Stilnoc contains lactose
Stilnoct contains lactose (a type of sugar). If you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Stilnoc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Stilnoct
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended dose of Stilnoct is 10 mg per 24 hours.
Some patients may be prescribed a lower dose.
Stilnoct should be taken:
- as a single dose
- in connection with bedtime. Do not take any additional dose on the same night.
Make sure that a period of at least 8 hours has passed after taking this medicine before doing activities that require you to be awake/alert.
Never take more than 10 mg per 24 hours.
Elderly (over 65 years) or patients with the impaired general condition are usually given 5 mg.
Patients with mild or moderately impaired liver function are usually given a starting dose of 5 mg.
Processing time:
The duration of the treatment should be as short as possible. Treatment should not exceed 4 weeks.
If you feel that the effect of Stilnoct is too strong or too weak, consult a doctor or pharmacist.
Stilnoct 10 mg tablet is scored on one side. The tablet can be divided into two equal doses.
Use for children and adolescents
Children and young people under the age of 18 should not use Stilnoct, as there is no information on such use.
If you have taken too much Stilnoct
If you have ingested too much medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Stilnoct
If you forget to take a dose immediately before going to bed but remember it during the night, you should only take the missed dose if you still have the opportunity to sleep 7-8 hours.
If you stop taking Stilnoct
If the treatment is stopped suddenly, the sleep problems may worsen. Withdrawal symptoms can occur, e.g. headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Stilnoct and contact your doctor immediately if you experience any of the following symptoms ( angioedema )
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
Other side effects that may occur:
Common (may affect up to 1 in 10 users):
- dizziness, drowsiness, headache, worsening insomnia, and problems with memory that can also affect behavior, e.g. learning difficulties, difficulty planning, problems with attention, or problems with speech
- hallucinations, agitation, nightmares
- fatigue
- back pain
- stomach and intestinal problems such as diarrhea, nausea, vomiting, and stomach ache
- Depression
Uncommon (may affect up to 1 in 100 users):
- confusion, confusion
- double vision
- restlessness, aggressiveness
- Stilnoctus can cause you to walk in your sleep. Other behaviors that are unusual during sleep and that you perform without being fully awake (such as driving, eating, making phone calls or having sex, etc.) may also occur. See section 2 “Warnings and precautions” for further information.
- skin rash, itching, abnormal sweating
- elevated liver values
- muscle weakness
Rare (may affect up to 1 in 1,000 users):
- reduced level of consciousness
- changes in sexual desire
- unsteady gait falls (especially in elderly patients and when Stilnoc is not taken as prescribed) (see section 2 “Warnings and precautions” for further information)
- hives
- liver damage
Very rare (may affect up to 1 in 10,000 users):
- delusions, dependence (need to continue medication accompanied by unpleasant symptoms when treatment is suddenly discontinued)
Has been reported (occurring in an unknown number of users):
- anger, various changes in behavior, tolerance (reduced effect of the sleeping pill)
- delirium (a sudden and severe change in a mental state that makes a person appear confused or disoriented)
How Stilnoct should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton/label (EXP:). The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is zolpidem tartrate 5 mg and 10 mg respectively.
- Other ingredients are lactose monohydrate 45 mg and 90 mg respectively, magnesium stearate, hypromellose, microcrystalline cellulose, sodium starch glycolate, macrogol 400, and the dye titanium dioxide (E 171).
Appearance and package sizes of the medicine
Stilnoct 5 mg is a white, round, film-coated tablet.
Stilnoct 10 mg is a white, oval film-coated tablet with a score on one side and marked “SN 10”.
Stilnoct is available in packs of 7, 10, 14, 30, 98×1 tablets (blister), and 100 tablets (can).
Stilnoct 5 mg is also available in cans of 250 and 500 tablets (only for dose dispensing).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi AB, Box 30052, 104 25 Stockholm