Sublinox

Brand Name

Sublinox

Common Name

zolpidem

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Zolpidem belongs to the class of medications called sedative-hypnotics. It is used for the short-term and symptomatic relief of sleep disturbances. Zolpidem can help with difficulty falling asleep, frequent wake-ups during the night, or early morning awakenings. Zolpidem should usually not be taken for more than 7 to 10 consecutive days. It should only be used if disturbed sleep causes problems functioning during the day.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

Women have higher levels of zolpidem in the blood than men when given the same dose. It also takes longer for women for the medication to be cleared from the body. The recommended adult dose of zolpidem is 5 mg for women and 5 mg to 10 mg for men. People over the age of 65 are more sensitive to the effects of this medication and should be started on a lower dose, regardless of their gender.

This medication should be taken just before bedtime when required to help with sleep disturbances. Zolpidem may be habit-forming and should be taken exactly as prescribed by your doctor. You should not typically use zolpidem for more than 7 to 10 consecutive days.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Zolpidem disintegrating tablets should be placed under the tongue, where it will dissolve. Do not chew or swallow the tablet, and do not take it with water. Sublinox tablets cannot be split.

Do not take zolpidem with food or immediately after a meal. Food slows down the speed at which the medication works, increasing the length of time before the onset of sleep.

If you have been taking this medication regularly for 2 weeks or longer, do not stop taking it suddenly without talking with your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you forget to take your tablet at bedtime, do not take it at any other time or in the middle of the night. Do not take this medication when a full night's sleep (7 to 8 hours) is not possible (i.e., after waking in the middle of the night) or before you would need to be active and functional. Impaired judgment and memory lapses may occur in such situations. Your body needs time to process and get rid of the medication.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

5 mg
Each round, white, flat-faced, bevelled-edged, sublingual tablet, marked with "V" on one side, contains 5 mg of zolpidem. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, saccharin sodium, and silicified microcrystalline cellulose.

10 mg
Each round, white, flat-faced, bevelled-edged, sublingual tablet, marked with "X" on one side, contains 10 mg of zolpidem. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, saccharin sodium, and silicified microcrystalline cellulose.

Who should NOT take this medication?

Do not take zolpidem if you:

• are allergic to zolpidem or any ingredients of this medication
• have a history or a family history of sleepwalking
• have a history of reactions to other sedative medications, such as performing activities while not fully awake (e.g., eating, driving, sexual activity)
• have myasthenia gravis
• have severe breathing difficulties
• have severely reduced liver function or liver disease
• have severe lung or respiratory disease, including sleep apnea

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back or muscle pain
• constipation
• diarrhea
• dizziness
• drowsiness
• dry mouth
• excitement
• fatigue
• headache
• hyperactivity
• increased difficulty sleeping
• itching
• loss of appetite
• nausea
• rash
• unusual dreams
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• behaviour changes (e.g., mood or mental changes, irritability, anger, aggression, violent behaviour)
• blurred vision
• broken bones caused by falling
• chest pain
• confusion (more common for seniors)
• daytime anxiety or restlessness
• decreased coordination
• drowsiness (severe)
• "drugged" feeling
• hallucinations (seeing or hearing things that aren't there)
• increased falls
• memory problems
• muscle weakness
• performing activities while sleeping (e.g., driving, cooking, sleepwalking)
• pounding heartbeat
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• withdrawal effects (e.g., abdominal cramps, vomiting, sweating, tremor, seizures, hallucinations, confusion, disorientation)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• slow, shallow or weak breathing
• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol and other medications that cause drowsiness: People taking this medication should not combine it with alcohol and should avoid combining it with other medications, such as narcotic pain relievers or other medications that cause drowsiness. Doing so can cause additive drowsiness and reduced breathing, as well as other side effects, which can be dangerous and possibly life-threatening.

Allergic reaction: In rare cases, people have developed a serious allergic reaction to medications like zolpidem involving swelling of the tongue, glottis, or larynx. Some people have had shortness of breath, nausea, vomiting, or throat closing.

Other signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If you experience any of these symptoms after taking zolpidem, seek immediate medical attention.

Behaviour changes: This medication may cause agitated or aggressive behaviour. If you experience these symptoms or any other behaviour change while taking this medication, contact your doctor immediately.

Family members or caregivers of people who are taking this medication should contact the person's doctor immediately if they notice unusual behaviour changes.

Breathing problems: Zolpidem can suppress breathing. If you are at risk for breathing difficulties, such as asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Confusion: This medication affects mental efficiency (e.g., concentration, attention, and vigilance). The risk of confusion is greater for seniors and those with brain damage.

Dependence and withdrawal: Physical dependence, psychological dependence, and abuse have occurred with the use of zolpidem. If you have a history of past or current substance use problems you may be at greater risk of developing abuse or addiction while taking this medication.

Withdrawal symptoms have been observed after stopping the medication suddenly (after having taken it regularly over a period of time). These symptoms include:

• abdominal cramps
• anxiety
• diarrhea
• fatigue
• flushing
• headache
• irritability
• memory impairment
• nausea
• nervousness
• restlessness
• seizures
• sleep problems such as rebound insomnia
• sweating
• tension
• tremors
• vomiting

If you have been taking this medication for longer than 10 days, discuss with your doctor the best way to stop zolpidem.

Depression: Medications used for sleep disturbances have been known to cause mood swings and symptoms of depression. Zolpidem may worsen symptoms of depression, including thoughts of suicide or wanting to harm others.

If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Drowsiness/reduced alertness: Zolpidem can cause excessive daytime drowsiness and decreased mental alertness. Do not drive, operate machinery, or perform other dangerous tasks until you know how this medication affects you.

Falls and Fractures: Zolpidem can cause drowsiness or dizziness that can affect your balance and increase your risk of falling. This can result in fractures or other injuries. Your risk of falling is increased if you drink alcohol or take sedatives while taking this medication, you are elderly, or have a condition that causes weakness or frailty.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Memory disturbance: Although rare, amnesia of varying severity has been reported following normal doses of medications like zolpidem. This is an unpredictable effect of the medication. If you experience any memory problems while taking this medication, contact your doctor.

Performing activities while not fully awake: People taking zolpidem may perform activities such as sleepwalking, driving, preparing and eating food, and making phone calls while not fully awake and are unaware of their actions. The next morning, they may not remember what happened. This may be more likely to occur if you use alcohol or other sedative medications. If you discover this has happened to you, contact your doctor immediately.

Family members or caregivers of people who are taking this medication should contact the person's doctor immediately if they notice any of these unusual behaviours.

Rebound insomnia: As with other medications used to aid in sleeping, you may experience a temporary return of your sleeping difficulties when zolpidem is stopped.

Pregnancy: The use of zolpidem during pregnancy has not been studied. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking zolpidem, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of zolpidem have not been established for use by children and adolescents less than 18 years of age.

Seniors: People over 65 years of age are more likely to experience dose-related side effects of zolpidem, such as drowsiness, dizziness, or impaired coordination. Lower doses of zolpidem are recommended for seniors.

What other drugs could interact with this medication?

There may be an interaction between zolpidem and any of the following:

• alcohol
• anticonvulsants (medications used to prevent seizures; e.g., phenytoin, valproic acid, carbamazepine, gabapentin)
• antihistamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotic medications (e.g., haloperidol, olanzapine, pimozide, quetiapine, risperidone)
• apalutamide
• "azole" antifungals (e.g., ketoconazole, itraconazole, voriconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• bosentan
• brimonidine
• buprenorphine
• cannabis
• chloral hydrate
• ciprofloxacin
• clonidine
• cobicistat
• diphenoxylate
• elagolix
• entacapone
• enzalutamide
• esketamine
• flunarizine
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, nevirapine)
• HIV protease inhibitors (e.g., darunavir, indinavir, ritonavir, saquinavir)
• kava kava
• lemborexant
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maprotiline
• melatonin
• methadone
• metoclopramide
• mifepristone
• mirtazapine
• mitotane
• modafinil
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• narcotic or opioid medications (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
• pomalidomide
• protein kinase inhibitors (e.g., ceritinib, dabrafenib, dasatinib, imatinib, nilotinib, sunitinib)
• pramipexole
• pregabalin
• rifabutin
• rifampin
• ropinirole
• rotigotine
• St. John's wort
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluvoxamine, fluoxetine, paroxetine, sertraline)
• tetrabenazine
• thalidomide
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, desipramine)
• valerian
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sublinox