Zolpimist

Zolpimist is a prescription medication used in adults for the short-term treatment of insomnia (difficulty falling asleep). Zolpimist belongs to a group of drugs called hypnotics. It works by slowing down brain activity so you can fall asleep.

Zolpimist comes in spray form and is taken by mouth just before bedtime.

Common side effects of Zolpimist include daytime drowsiness, dizziness, and diarrhea. Do not drive or operate heavy machinery until you know how Zolpimist affects you.

Zolpimist is a prescription medicine used in adults for the treatment of a sleep problem called insomnia (difficulty falling asleep). It slows brain activity to allow sleep.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• ECR Pharmaceuticals Co., Inc.

Warning: Impairment from sleep drugs can be present despite feeling fully awake.

You may still feel drowsy the next day after taking Zolpimist. Do not drive or operate heavy machinery or take part in anything that requires alertness after taking Zolpimist until you are certain you are alert.

Serious side effects of Zolpimist may include:

• getting out of bed while not being fully awake and taking part in an activity that you do not know you are doing
• abnormal thoughts and behavior including:
  • more outgoing or aggressive behavior than normal
  • confusion 
  • agitation
  • hallucinations (seeing or hearing things that aren't there)
  • worsening of depression
  • suicidal thoughts or actions
• memory loss
• anxiety
• severe allergic reactions including:
• swelling of the tongue or throat
• trouble breathing
• nausea and vomiting

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Zolpimist.

The most common side effects of Zolpimist are:

• drowsiness
• dizziness
• diarrhea
• "drugged feelings"

Some people experience symptoms such as trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain after stopping sleep medicine. This may last 1-2 days. 

This is not a complete list of Zolpimist side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Do not take Zolpimist with other medicines that make you sleepy. Be sure to tell your doctor if you take:

• antidepressants such as imipramine (Tofranil) and sertraline (Zoloft)
• chlorpromazine (Thorazine)
• antifungal medicines such as itraconazole (Sporanox) and  ketoconazole (Nizoral)
• medications for anxiety
• cold medicines or allergy medicines
• medicines for mental illness
• pain medicines
• medicines for seizures
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers.

This is not a complete list of Zolpimist drug interactions. Ask your doctor or pharmacist for more information.

After taking Zolpimist, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You should be aware that impairment from sleep drugs can be present despite feeling fully awake. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Zolpimist.

Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking Zolpimist.

• Take Zolpimist right before you get in bed, not sooner.
• Do not take Zolpimist if you drank alcohol that evening or before bed
• Do not take Zolpimist with other medicines that can make you sleepy. 
• Do not take Zolpimist if you cannot get a full night's sleep or stay in bed 7 or 8 hours before being active again.
• Do not take Zolpimist if you are allergic to anything in it. Severe allergic reactions have occurred with Zolpimist use. Seek emergency medical attention if you have unexplained rash, itching, hives, wheezing or trouble breathing, or unexplained swelling (especially of the throat, lips, or mouth).
• Do not take Zolpimist if you have had an allergic reaction to zolpidem, such as Ambien, Ambien CR, Edluar, or Intermezzo.

Zolpimist can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Zolpimist affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zolpimist there are no specific foods that you must exclude from your diet when receiving Zolpimist.

Before receiving Zolpimist, tell your doctor about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or are planning to breastfeed. Zolpimist is excreted into human milk. It is not known if Zolpimist will harm your nursing baby.

Take Zolpimist exactly as prescribed. Do not take more Zolpimist than prescribed for you.

• Take Zolpimist right before you get into bed, not sooner.
• Only take 1 Zolpimist dose a night if needed.
• Do not take Zolpimist unless you are able to stay in bed a full night (7–8 hours) before you must be active again.
• Zolpimist should be taken without food.
• Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

• If you are using Zolpimist for the first time or you have not used Zolpimist for 14 days, you will need to prime the pump (Steps 1-6). Otherwise, there is no need to prime the pump.

• Take Zolpimist exactly as prescribed. Do not take more Zolpimist than prescribed for you. Your healthcare provider will tell you whether to take 1 or 2 sprays of Zolpimist.

Take Zolpimist exactly as your doctor has prescribed it. Follow the directions on your prescription label carefully. 

Zolpimist Spray

The recommended dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime.

For geriatric patients and patients with liver impairment, the recommended dose is 5 mg for men and women.

If you take too much Zolpimist call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Zolpimist in an upright position between 59 °F to 86 °F (15°C to 30 °C).
• Do not freeze.
• Avoid prolonged product exposure above 86 °F (30 °C).
• The child -resistant container should be thrown away when the 60 sprays have been used.
• Keep Zolpimist and all medicines out of reach of children.
• Zolpimist is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Zolpimist in a safe place to prevent misuse and abuse. Selling or giving away Zolpimist may harm others, and is against the law.

Zolpimist is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Zolpimist in a safe place to prevent misuse and abuse. Selling or giving away Zolpimist may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.