Patient Medication Information: uses, side effects, how to take - Som-Pam
Serious Warnings and Precautions
Addiction, Abuse and Misuse: Even if you take SOM-PAM exactly as you were told to, you are at risk for abuse, misuse, addiction, physical dependence and withdrawal. Abuse and misuse can result in overdose or death, especially if you take SOM-PAM with:
Your healthcare professional should:
Store SOM-PAM in a secure place to avoid theft or misuse. Withdrawal: If you suddenly stop taking SOM-PAM, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms (see Other warnings you should know about)
SOM-PAM with Opioids: Taking SOM-PAM with opioid medicines can cause:
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What is SOM-PAM used for?
SOM-PAM is used in adults to treat short-term insomnia. This is a sleep disorder that makes it hard to fall asleep, hard to stay asleep, or causes you to wake up too early. SOM-PAM should only be used when the effects of insomnia affect your daytime activities. Treatment with SOM-PAM is short-term and should usually not exceed 7 to 10 days in a row.
If you are 65 years or older, talk to your healthcare professional before starting SOM-PAM. SOM-PAM may not be an effective treatment for you and you may be more sensitive to experiencing side effects.
How does SOM-PAM work?
SOM-PAM belongs to a group of medicines called benzodiazepine sleeping pills. It works to decrease the time required to fall asleep and the number of times you wake up during sleep.
What are the ingredients in SOM-PAM?
Medicinal ingredients: Flurazepam hydrochloride
Non-medicinal ingredients: cornstarch, gelatin, and lactose.
SOM-PAM comes in the following dosage forms:
Capsules: 15 mg and 30 mg.
Do not use SOM-PAM if:
- you are allergic to flurazepam or other benzodiazepines, or to any of the ingredients in SOM-PAM (see “What are the ingredients in SOM-PAM?”)
- you have severe lung or breathing problems (e.g. sleep apnea)
- you have myasthenia gravis (a condition characterized by weakness of your muscles).
- you have a severe liver condition.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SOM-PAM. Talk about any health conditions or problems you may have, including if you:
- have a lung disease or breathing problems.
- have a liver or kidney condition.
- have signs of depression, or a history of depression.
- have a history of suicide thoughts or attempts.
- have a history of violent behaviours.
- have a history of any personality disorder.
have had unexpected reactions to alcohol or sedative medications in the past (e.g. such as irritability, aggression, hallucinations, etc.).
- are pregnant or planning to become pregnant, SOM-PAM is not recommended for use during pregnancy.
- are breastfeeding or planning to breast-feed, SOM-PAM is not recommended for use during breastfeeding.
- drink or plan to drink alcohol. Do not drink alcohol while you take SOM-PAM.
- are taking other medications, including over-the-counter medications, opioids, sedatives, medications that affect your central nervous system (CNS depressants).
- are taking illicit drugs.
- have lactose intolerance, as SOM-PAM contains lactose.
- are 65 years of age or older.
- have a condition that causes weakness or frailty.
- have impaired thinking, confusion or any other type of brain damage.
have ever had a problem with:
- substance use, including prescribed or illegal drugs, or
- alcohol
- have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness)
Other warnings you should know about:
Sleep-Related Behaviours: Treatment with SOM-PAM can cause potentially dangerous sleeping-related behaviours such as getting out of bed while not fully awake after taking SOM-PAM and doing activities that you do not know you are doing. If this happens, you may not remember doing these activities when you wake up. These unusual behaviours are more likely to occur when SOM-PAM is taken with alcohol or other drugs that can make you sleepy (e.g. medications used to treat depression or anxiety). If you drink alcohol, do not take SOM-PAM. The activities you may do in these situations can put you and people around you in danger. This can include driving a car (“sleep-driving”), leaving the house, making and eating food, talking on the phone.
You and people close to you should watch for unusual types of behaviour when you are asleep. If you find out that you have done any such activities for which you have no memory, you should call your healthcare professional immediately.
Memory Problems: In rare cases, SOM-PAM can cause a type of memory loss known as amnesia. This is characterized by having difficulty recalling events that recently occurred, usually several hours after taking the medication. If you intend to take SOM-PAM before sleeping, this is usually not a problem. However, if you take SOM-PAM to induce sleep while travelling, such as during an airplane flight, you may wake up to memory lapse caused by the drug. This has been called “traveller's amnesia” and can be a problem. DO NOT TAKE SOM-PAM when a full night's sleep is not possible before you need to be active and functional (e.g., an overnight flight of less than 8 hours). Your body needs time to eliminate the medication from your system.
Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop SOM-PAM.
Your risk of going through withdrawal is higher if you are taking SOM-PAM for a long time or at high doses. However, symptoms can still occur if you are taking SOM-PAM as directed for a short period of time or slowly reducing the dose.
The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).
Tell your healthcare professional right away if you experience any symptoms of withdrawal after changing or stopping your treatment.
Severe symptoms of withdrawal include:
- feeling like you cannot move or respond (catatonia)
- severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens)
- feeling depressed
- feeling disconnected from reality (dissociation)
- seeing or hearing things that are not there (hallucinations)
- overactive behavior and thoughts (mania)
- believing in things that are not true (psychosis)
- convulsions (seizures), including some that do not stop
- thoughts or actions of suicide
For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).
To reduce your chances of going through withdrawal:
- always contact your healthcare professional before stopping or reducing your dose of SOM-PAM or changing medications
- always follow your healthcare professional’s instructions on how to reduce your dose carefully and safely
- tell your healthcare professional right away if you experience any unusual symptoms after changing or stopping your treatment
SOM-PAM with Opioids: Taking SOM-PAM with opioid medicines can cause severe drowsiness and breathing problems.
Tell your healthcare professional if you:
- are taking opioid medicines
- are prescribed an opioid medicine after you start taking SOM-PAM
Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and SOM-PAM affects you.
Falls and Fractures: there have been reports of falls and fractures in people who take benzodiazepines such as SOM-PAM. You have a greater risk of falling, which can cause fractures or other fall related-injuries if you:
- take other sedatives
- consume alcohol
- are elderly or
- have a condition that causes weakness or frailty
Mental and Behavioural Changes: A variety of abnormal thinking and behaviour changes may occur when you take benzodiazepine sleeping pills, including SOM-PAM. Some of these changes include aggressiveness and extroversion, which seem out of character, confusion, strange behaviour, anxiety, restlessness, hallucinations, feeling like you are not yourself, worsening insomnia or depression, including suicidal thinking. It is hard to determine if these symptoms are caused by the medication, by an illness that was present before the medication was used, or are natural. If you develop any unusual thoughts or behaviour while using SOM-PAM, tell your healthcare professional right away.
Worsening of Side Effects: DO NOT CONSUME ALCOHOL WHILE TAKING SOM-PAM.
Your symptoms of insomnia may worsen with SOM-PAM, especially if you are taking other similar medications.
Severe Allergic Reaction: In rare cases, SOM-PAM has caused severe allergic reactions including anaphylaxis, which can be life-threatening. The symptoms of a severe allergic reaction include angioedema of the tongue or throat (swelling of tissues under the skin), shortness of breath, throat closing, nausea or vomiting. Angioedema can lead to a blocked airway and can be life-threatening. If you develop angioedema or you notice signs of a severe allergic reaction after taking SOM-PAM, you should stop taking SOM-PAM and tell your healthcare professional right away.
Elderly: If you are 65 years of age or older and take benzodiazepines including SOM-PAM, you are at a higher risk of falls and fractures.
Pregnancy: Benzodiazepines, such as SOM-PAM, may cause a risk to your unborn baby (e.g., birth defects) if you are pregnant. This typically occurs more often during the first trimester or last weeks of pregnancy. If you are able to get pregnant, want to be or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
Monitoring and Testing: If you are prescribed SOM-PAM, your healthcare professional may conduct blood tests to assess your health as well as your liver and kidney function. Your healthcare professional will interpret your results and may adjust or stop your dose of SOM-PAM.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SOM-PAM:
| Serious Drug Interactions |
Taking SOM-PAM and opioids may cause:
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- alcohol, do not take SOM-PAM if you drink alcohol.
- sedative antihistamines that are used to treat allergies but make you drowsy or sleepy after you take them.
- anticonvulsants used to prevent or treat seizures.
- antidepressants used to treat depression.
- medicines used to alter your mental state or mood.
- other benzodiazepines typically used to treat anxiety, insomnia, and seizures (e.g., oxazepam).
- medicines that inhibit certain liver enzymes, particularly cytochrome P450 (e.g., cimetidine and erythromycin). If you are unsure, talk to your healthcare professional.
DO NOT USE SOM-PAM with other medications without first discussing this with your healthcare professional.
How to take SOM-PAM:
- Take SOM-PAM exactly as your healthcare professional has told you to.
- Take SOM-PAM just before bedtime. Do not take SOM-PAM if a full night’s sleep is not possible before you need to become active and functional again.
- Do NOT consume any alcohol while taking SOM-PAM.
- Do NOT suddenly stop taking SOM-PAM or you may experience withdrawal symptoms.
Usual dose:
Adults: 30 mg just before bedtime, although some patients may require only 15 mg.
Elderly and/or Debilitated Patients: 15 mg just before bedtime.
Your healthcare professional will slowly decrease your dose and will tell you when to stop taking the medicine. Always follow your healthcare professional’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
Overdose:
Symptoms of an overdose with SOM-PAM include drowsiness, sleepiness, confusion and coma.
| If you think you, or a person you are caring for, have taken too much SOM-PAM, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed dose:
If you forget or miss a dose of SOM-PAM, do not take the missed dose. Instead, take the next scheduled dose at the usual time. Do not try to make up for the missed dose by taking a double dose.
What are possible side effects from using SOM-PAM?
These are not all the possible side effects you may have when taking SOM-PAM. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of SOM-PAM may include:
Very common (may affect more than 1 in 10 people):
- drowsiness,
- dizziness,
- light-headedness,
- difficulty with coordination.
Common (may affect up to 1 in 10 people):
- lethargy,
- disorientation (inability to know correct time, place or person),
- apprehension (worry about something or about what might happen),
- nervousness,
- heartburn,
- upset stomach,
- nausea,
- constipation,
- stomach pain,
- weakness,
- chest pains,
- urinary and genital problems,
- palpitations (heartbeats that become more noticeable).
Rare (may affect up to 1 in 10,000 people):
- flushing (redness of skin),
- blurred vision,
- fainting,
- itchiness,
- skin rash,
- dry mouth,
- bitter taste,
- excessive salivation
- anorexia (a weight disorder characterized by low weight).
Unknown:
- falls and fractures
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Severe sedation: reduced awareness, or reduced response to stimulation | ✓ | ||
| RARE | |||
| Amnesia (a type of memory loss): difficulty recalling events that recently happened | ✓ | ||
| Depression (sad mood that won’t go away): difficulty sleeping, sleeping too much, changes in | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| appetite or weight, feelings of worthlessness, guilt, regret, helplessness, hopelessness, withdrawal from social situations, family, gatherings and activities with friends, thoughts of death or suicide, or reduced libido (sex drive) | |||
| Low white blood cells (e.g., leukopenia or granulocytopenia): infections, fatigue, fever, aches, pains, or flu-like symptoms | ✓ | ||
| Mental and behavioural changes: difficulty focusing, euphoria, excitement, nightmares, numbed emotions, decreased alertness, agitation, hyperactivity, worsened insomnia, aggressiveness, rages, psychoses, violent behaviour, or inappropriate behaviour | ✓ | ||
Severe allergic reactions: swelling of the tongue or throat, trouble breathing, sudden wheeziness, chest pain or tightness, shortness of breath, throat closing, nausea or vomiting | ✓ | ||
| VERY RARE | |||
| Somnambulism (sleepwalking): getting out of bed while not fully awake and do activities you do not remember the day after, or sleep driving | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Overdose: extreme sleepiness, confusion, slurred speech, slow reflexes, slow shallow breathing, coma, loss of balance and coordination, uncontrolled rolling of the eyes, and low blood pressure. | ✓ | ||
| Respiratory Depression: slow, shallow or weak breathing. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases |
|---|---|
Withdrawal: Severe symptoms include: Catatonia: feeling like you cannot move or respond Delirium Tremens: severe confusion, shivering, irregular heartrate and excessive sweating Feeling depressed Dissociation: feeling disconnected from reality Hallucinations: seeing or hearing things that are not there Mania: overactive behaviour and thoughts Psychosis: believing in things that are not true Convulsions: (seizures – including some that do not stop): loss of consciousness with uncontrollable shaking Thoughts or actions of suicide Other symptoms include: Stomach cramps; trouble remembering or concentrating; diarrhea; feeling uneasy or restless; severe anxiety or panic-attacks; headache; sensitivity to light, noise or physical contact; shaking; vomiting; trouble sleeping; feeling irritable; muscle pain or stiffness; a burning or prickling feeling in the hands, arms, legs or feet; sweating. | |
| ✓ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at 15-30°C in tightly closed, light resistant container.
Keep out of reach and sight of children.
If you want more information about SOM-PAM:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/eu/health-canada/services/drugs-health/drug-products/drug-product-database-html or by contacting the manufacturer at: info@biomed-pharma.ca , or by calling 1-888-731-6703.