Does ropinirole help you sleep

Ropinirole

Before taking ropinirole,

  • tell your doctor and pharmacist if you are allergic to ropinirole, any other medications, or any of the ingredients in ropinirole tablets or extended-release tablets. Ask your doctor or pharmacist for a list of ingredients in ropinirole regular or extended-release tablets.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants (‘mood elevators’); antipsychotics (medications for mental illness); cimetidine (Tagamet, Tagamet HB); fluoroquinolone antibiotics such as ciprofloxacin (Cipro), and norfloxacin (Noroxin); fluvoxamine (Luvox); hormone replacement therapy and hormonal contraceptives (birth control pill, patches, rings, and injections); insulin; lansoprazole (Prevacid); levodopa (in Sinemet, in Stalevo); medications for anxiety and seizures; medications that cause drowsiness; metoclopramide (Reglan); mexiletine (Mexitil); modafanil (Provigil); nafcillin; omeprazole (Prilosec, Zegerid); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Be sure to tell your doctor or pharmacist if you stop taking any medications while you are taking ropinirole.
  • tell your doctor if you have ever had an urge to gamble that was difficult to control and if you have or have ever had unexpected daytime sleepiness or a sleep disorder other than restless legs syndrome; high or low blood pressure; a psychotic disorder (mental illness that causes abnormal thinking or perceptions); or heart, liver, or kidney disease.
  • tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking ropinirole, call your doctor. Also tell your doctor if you are breast-feeding. Ropinirole may decrease the amount of your breast milk.
  • you should know that ropinirole may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities. You might not feel drowsy or have any other warning signs before you suddenly fall asleep. Do not drive a car, operate machinery, work at heights, or participate in potentially dangerous activities at the beginning of your treatment until you know how the medication affects you. If you suddenly fall asleep while you are doing something such as watching television, talking, eating, or riding in a car, or if you become very drowsy, especially during the daytime, call your doctor. Do not drive, work in high places, or operate machinery until you talk to your doctor.
  • remember that alcohol can add to the drowsiness caused by this medication. Tell your doctor if you regularly drink alcoholic drinks.
  • tell your doctor if you use tobacco products. Call your doctor if you start or stop smoking during your treatment with ropinirole. Smoking may decrease the effectiveness of this medication.
  • you should know that some people who took medications such as ropinirole developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have an urge to gamble that is difficult to control, you have intense urges, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.
  • you should know that ropinirole may cause dizziness, lightheadedness, nausea, or sweating when you get up too quickly from a sitting or lying position. This is more common when you first start taking ropinirole or with an increase in the dose of ropinirole. To avoid this problem, get out of the chair or bed slowly, resting your feet on the floor for a few minutes before standing up.

About ropinirole

Type of medicine A dopamine-receptor agonist
Used for Parkinson’s disease; restless legs syndrome
Also called For Parkinson’s disease: Aimpart® XL; Ippinia®; Ralnea® XL; Raponer®; Repinex® XL; Requip®; Requip® XL; Ropilynz® XL; Ropiqual® XL; Spiroco® XL
For restless legs syndrome: Adartrel®;
Available as Tablets and prolonged-release tablets

Most brands of ropinirole tablets are prescribed to treat Parkinson’s disease. Parkinson’s disease affects the way your brain co-ordinates the movements of your muscles. A number of cells in a small part of your brain called the substantia nigra become damaged and die. These brain cells pass messages down nerves in the spinal cord by producing a chemical called dopamine, and it is these messages which control the muscles of the body. As the cells in the brain are damaged, the amount of dopamine that is produced is reduced. A combination of the reduction of cells and a low level of dopamine in the cells in this part of the brain, causes nerve messages to the muscles to become slowed and abnormal. This produces the main symptoms of Parkinson’s disease, which are stiffness, shaking (tremor), and slowness of movement.

Ropinirole is a dopamine-receptor agonist which means that it acts on the same receptors in your brain as dopamine. In effect, it acts like a substitute for dopamine and this helps to ease your symptoms. It may be used alone, or in combination with other medicines to treat Parkinson’s disease.
A brand of ropinirole called Adartrel® is used to treat restless legs syndrome (RLS). This is an uncomfortable feeling in your legs, which gives you the urge to move your legs to get relief. Ropinirole can help when these symptoms are severe enough to cause distress.

Before taking ropinirole

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking ropinirole it is important that your doctor knows:

  • If you are pregnant, trying for a baby or breastfeeding.
  • If you have a heart condition or a blood vessel disorder.
  • If you have any problems with the way your liver works, or any problems with the way your kidneys work.
  • If you have ever had a mental health problem such as psychosis.
  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to a medicine.

How to take ropinirole

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack and any additional information your doctor has given to you. These will give you more information about ropinirole, and will also provide you with a full list of side-effects which you could experience from taking it.
  • The dose you are prescribed will be tailored to suit you. Your doctor will tell you how many tablets to take, and how often to take them. This information will also be printed on the label of the pack of tablets to remind you about what the doctor said to you. Read the directions from your doctor carefully so that you know what dose is right for you each day, and take the tablets exactly as you have been told.
  • If you are taking ropinirole for the first time, your doctor will give you a small dose to begin with, and then gradually increase this over the first few weeks. Slowly increasing your dose like this will help to reduce side-effects such as dizziness and low blood pressure, which can occur when you first start treatment.
  • It is best to take ropinirole tablets after a meal or a snack. This will help to prevent feelings of sickness which can sometimes occur.
  • If you have been given a prolonged-release tablet of ropinirole for Parkinson’s disease (these have ‘XL’ after the brand name), you should swallow the tablet whole. You can take it with a drink of water to help you swallow, but do not crush or break the tablet before you swallow it. This is because the tablets have been specially made to release the medicine they contain slowly over the day.
  • If you are taking Adartrel® for restless legs syndrome, please take your doses just before you go to bed each evening.
  • Try to get into a habit of taking your doses at the same times of day each day, as this will help you to remember to take them regularly. If you forget to take a dose, take it as soon as you remember. Try to take the correct number of doses each day, but do not take two doses at the same time to make up for a missed dose.
  • There are several different strengths and brands of ropinirole tablet. Each time you collect a prescription, please check the box to make sure that you have been given the type of tablets you are expecting. Ask your pharmacist to check for you if you are unsure about anything.

Getting the most from your treatment

  • Try to keep all your regular appointments with your doctor. This is so your doctor can check on your progress. Ropinirole could cause your blood pressure to fall (particularly in the early days of your treatment) and your doctor will want to check for this.
  • Keep taking the tablets until your doctor tells you otherwise. Stopping suddenly can cause problems and your doctor will want you to reduce your dose gradually if you need to stop treatment. Also, if for any reason you do not take your tablets for more than a day or so, you should let your doctor know about this, as your dose may need adjusting.
  • Sometimes people taking medicines like ropinirole can fall asleep suddenly during the day with little or no warning of being tired beforehand. Until you know how you react, take extra care if you drive or operate machinery. If you do find yourself falling asleep suddenly, you should see your doctor as soon as possible for advice, and avoid driving, or using tools and machines, in the meantime.
  • Treatment with medicines like ropinirole can sometimes cause problems with impulsive types of behaviour. If you notice any changes in your behaviour, such as an increased desire to gamble, binge eat, or spend excessively, or an increased sex drive, you must let your doctor know as soon as possible.
  • People with Parkinson’s disease are likely to be advised to stay as active as possible and to exercise regularly as much as they are able. You may walk more slowly than before, but a daily walk is good exercise and may help to loosen up stiff muscles.
  • If you are a driver you should tell the DVLA and your insurance company if you have Parkinson’s disease. Depending on the severity of symptoms and the medicines that you are taking, you may still be allowed to drive following a medical assessment.
  • Smoking can interfere with the way ropinirole works. If you either start smoking or give up smoking while you are taking ropinirole, your dose may need to be adjusted, so you should let your doctor know about this.

Can ropinirole cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the common ones associated with ropinirole. You will find a full list in the manufacturer’s information leaflet supplied with the tablets. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Very common ropinirole side-effects (these affect more than 1 in 10 people) What can I do if I experience this?
Feeling sick (nausea) or being sick (vomiting) Stick to simple or bland meals (avoid rich and spicy foods). Take your doses after food
Common ropinirole side-effects (these affect less than 1 in 10 people) What can I do if I experience this?
Feeling drowsy or sleepy, falling asleep suddenly during the day If this happens, do not drive and do not use tools or machines. Speak with your doctor as soon as possible if you start falling asleep suddenly during the day
Feeling dizzy or faint, especially when you stand or sit up Getting up and moving around more slowly may help. If you begin to feel dizzy, lie down so that you do not faint, then sit for a few moments before standing. This usually passes as your body gets used to the tablets, but in the meantime do not drive and do not use tools or machines
Swollen legs and ankles, feeling nervous or confused, indigestion, tummy (abdominal) pain, uncontrollable muscle movements, hearing or seeing things that aren’t real (hallucinations) If any of these become troublesome, speak with your doctor
Other ropinirole side-effects What can I do if I experience this?
Impulsive types of behaviour (such as an increased desire to gamble, binge eat, or an increased sex drive) Let your doctor know about this as soon as possible

If you experience any other symptoms which you think may be due to the tablets, please speak with your doctor or pharmacist for further advice.

How to store ropinirole

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

If you are due to have any treatment like an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking.

If you buy any medicines, always check with a pharmacist that they are safe to take with your other medicines.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine, please ask your pharmacist for advice.

What to do about restless legs syndrome

Published: March, 2012

Bedtime is far from relaxing for women with this common condition.

Restless legs syndrome (RLS) is a sensory-motor disorder that causes an irresistible urge to move the legs, often accompanied by an uncomfortable “creepy-crawly” sensation. RLS affects 3% to 5% of adults and is twice as common in women as in men. Symptoms typically flare at night, just as you’re settling down in bed, but they may also arise when you’re resting in a chair. RLS not only causes discomfort and distress, but can also wreak havoc on sleep, causing daytime sleepiness and mood changes. Fortunately, certain lifestyle strategies can help you manage milder forms of RLS, and several medications can provide relief for more serious symptoms.

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Requip

SIDE EFFECTS

The following adverse reactions are described in more detail in other sections of the label:

  • Hypersensitivity
  • Falling Asleep during Activities of Daily Living and Somnolence
  • Syncope
  • Hypotension/Orthostatic Hypotension
  • Hallucinations/Psychotic-like Behavior
  • Dyskinesia
  • Impulse Control/Compulsive Behaviors
  • Withdrawal-emergent Hyperpyrexia and Confusion
  • Melanoma
  • Augmentation and Early-morning rebound in RLS
  • Fibrotic Complications

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.

Parkinson’s Disease

During the premarketing development of REQUIP, patients received REQUIP either without L-dopa (early Parkinson’s disease trials) or as concomitant therapy with L-dopa (advanced Parkinson’s disease trials). Because these two populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these two populations separately.

Early Parkinson’s Disease (without L-dopa)

In the double-blind, placebo-controlled trials in patients with early-stage Parkinson’s disease, the most commonly observed adverse reactions in patients treated with REQUIP (incidence at least 5% greater than placebo) were nausea, somnolence, dizziness, syncope, asthenic condition (i.e., asthenia, fatigue, and/or malaise), viral infection, leg edema, vomiting, and dyspepsia.

Approximately 24% of patients treated with REQUIP who participated in the double-blind, placebo-controlled early Parkinson’s disease (without L-dopa) trials discontinued treatment due to adverse reactions compared with 13% of patients who received placebo. The most common adverse reactions in patients treated with REQUIP (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation were nausea and dizziness.

Table 3 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with early Parkinson’s disease (without L-dopa) treated with REQUIP participating in the doubleblind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either REQUIP or placebo was used as early therapy (i.e., without L-dopa).

Table 3: Treatment-emergent Adverse Reaction Incidence in Double-blind, Placebo-controlled Early Parkinson’s Disease (without L-dopa) Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Body System/
Adverse Reaction
REQUIP
(n = 157)
(%)
Placebo
(n = 147)
(%)
Autonomic nervous system
Flushing 3 1
Dry mouth 5 3
Increased sweating 6 4
Body as a whole
Asthenic conditionb 16 5
Chest pain 4 2
Dependent edema 6 3
Leg edema 7 1
Pain 8 4
Cardiovascular general
Hypertension 5 3
Hypotension 2 0
Orthostatic symptoms 6 5
Syncope 12 1
Central/peripheral nervous system
Dizziness 40 22
Hyperkinesia 2 1
Hypesthesia 4 2
Vertigo 2 0
Gastrointestinal
Abdominal pain 6 3
Anorexia 4 1
Dyspepsia 10 5
Flatulence 3 1
Nausea 60 22
Vomiting 12 7
Heart rate/rhythm
Extrasystoles 2 1
Atrial fibrillation 2 0
Palpitation 3 2
Tachycardia 2 0
Metaboli c/nutriti onal
Increased alkaline phosphatase 3 1
Psychiatric
Amnesia 3 1
Impaired concentration 2 0
Confusion 5 1
Hallucination 5 1
Somnolence 40 6
Yawning 3 0
Reproductive male
Impotence 3 1
Resistance mechanism
Viral infection 11 3
Respiratory
Bronchitis 3 1
Dyspnea 3 0
Pharyngitis 6 4
Rhinitis 4 3
Sinusitis 4 3
Urinary
Urinary tract infection 5 4
Vascular extracardiac
Peripheral ischemia 3 0
Vision
Eye abnormality 3 1
Abnormal vision 6 3
Xerophthalmia 2 0
a Patients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.
b Asthenic condition (i.e., asthenia, fatigue, and/or malaise).

Advanced Parkinson’s Disease (with L-dopa)

In the double-blind, placebo-controlled trials in patients with advanced-stage Parkinson’s disease, the most commonly observed adverse reactions in patients treated with REQUIP (incidence at least 5 % greater than placebo) were dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, increased sweating, and headache.

Approximately 24% of patients who received REQUIP in the double-blind, placebo-controlled advanced Parkinson’s disease (with L-dopa) trials discontinued treatment due to adverse reactions compared with 18% of patients who received placebo. The most common adverse reaction in patients treated with REQUIP (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was dizziness.

Table 4 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with advanced Parkinson’s disease (with L-dopa) treated with REQUIP who participated in the double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either REQUIP or placebo was used as an adjunct to L-dopa.

Table 4: Treatment-emergent Adverse Reaction Incidence in Double-blind, Placebocontrolled Advanced Parkinson’s Disease (with L-dopa) Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Body System/
Adverse Reaction
REQUIP
(n = 208)
(%)
Placebo
(n = 120)
(%)
Autonomic nervous system
Dry mouth 5 1
Increased sweating 7 2
Body as a whole
Increased drug level 7 3
Pain 5 3
Cardiovascular general
Hypotension 2 1
Syncope 3 2
Central/peripheral nervous system
Dizziness 26 16
Dyskinesia 34 13
Falls 10 7
Headache 17 12
Hypokinesia 5 4
Paresis 3 0
Paresthesia 5 3
Tremor 6 3
Gastrointestinal
Abdominal pain 9 8
Constipation 6 3
Diarrhea 5 3
Dysphagia 2 1
Flatulence 2 1
Nausea 30 18
Increased saliva 2 1
Vomiting 7 4
Metabolic/nutriti onal
Weight decrease 2 1
Musculoskeletal
Arthralgia 7 5
Arthritis 3 1
Psychiatric
Amnesia 5 1
Anxiety 6 3
Confusion 9 2
Abnormal dreaming 3 2
Hallucination 10 4
Nervousness 5 3
Somnolence 20 8
Red blood cell
Anemia 2 0
Resistance mechanism Upper respiratory tract infection 9 8
Respiratory
Dyspnea 3 2
Urinary
Pyuria 2 1
Urinary incontinence 2 1
Urinary tract infection 6 3
Vision
Diplopia 2 1
a Patients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.

Restless Legs Syndrome

In the double-blind, placebo-controlled trials in patients with RLS, the most commonly observed adverse reactions in patients treated with REQUIP (incidence at least 5% greater than placebo) were nausea, vomiting, somnolence, dizziness, and asthenic condition (i.e., asthenia, fatigue, and/or malaise).

Approximately 5% of patients treated with REQUIP who participated in the double-blind, placebo-controlled trials in the treatment of RLS discontinued treatment due to adverse reactions compared with 4% of patients who received placebo. The most common adverse reaction in patients treated with REQUIP (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was nausea.

Table 5 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with RLS treated with REQUIP participating in the 12-week, double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients.

Table 5: Treatment-emergent Adverse Reaction Incidence in Double-blind, Placebocontrolled RLS Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Body System/
Adverse Reaction
REQUIP
(n = 496)
(%)
Placebo
(n =500)
(%)
Ear and labyrinth
Vertigo 2 1
Gastrointestinal
Nausea 40 8
Vomiting 11 2
Diarrhea 5 3
Dyspepsia 4 3
Dry mouth 3 2
Abdominal pain upper 3 1
General disorders and administration site conditions
Asthenic conditionb 9 4
Edema peripheral 2 1
Infections and infestations
Nasopharyngitis 9 8
Influenza 3 2
Musculoskeletal and connective tissue
Arthralgia 4 3
Muscle cramps 3 2
Pain in extremity 3 2
Nervous system
Somnolence 12 6
Dizziness 11 5
Paresthesia 3 1
Respiratory, thoracic, and mediastinal
Cough 3 2
Nasal congestion 2 1
Skin and subcutaneous tissue
Hyperhidrosis 3 1
a Patients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.
b Asthenic condition (i.e., asthenia, fatigue, and/or malaise).

Read the entire FDA prescribing information for Requip (Ropinirole Hcl)

Parkinson Disease, RLS Treatment Ropinirole Hydrochloride To Be Discontinued

The FDA has announced the upcoming discontinuation for Parkinson disease and restless legs syndrome treatment ropinirole hydrochloride (Requip, GlaxoSmithKline).1
According to the FDA notice, the non-ergot dopamine agonist will be discontinued in its tablet form as well as some of its extended-release tablet formulations. The therapy is anticipated to cease availability of these forms by May 2019. The FDA notice stated that these discontinuations are the result of a business decision.
The treatment will still be available in its extended-release formulation in doses of 4-mg, 6-mg, 8-mg, and 12-mg tablets. The ropinirole hydrochloride tablets in 0.25-mg, 0.5-mg, 1-mg, 2-mg, 3-mg, 4-mg, and 5-mg doses in 100-count bottles, and the extended-release 2-mg tablets in 30-count bottles will be discontinued. The dates of final availability are expected to be as follows:
January 2019

  • Ropinirole hydrochloride 1 mg (NDC 00074892-20)
  • Ropinirole hydrochloride 2 mg (NDC 00074893-20)

March 2019

  • Ropinirole hydrochloride 5 mg (NDC 00074894-20)
  • Ropinirole hydrochloride extended-release 2 mg (NDC 0007-4885-13)

April 2019

  • Ropinirole hydrochloride 0.25 mg (NDC 00074890-20)
  • Ropinirole hydrochloride 3 mg (NDC 00074895-20).

May 2019

  • Ropinirole hydrochloride 0.5 mg (NDC 00074891-20)
  • Ropinirole hydrochloride 4 mg (NDC 00074896-20)

The treatment was originally approved as a treatment for the signs and symptoms of Parkinson disease both as initial therapy and adjunctive therapy with levodopa in September 1997. The extended-release formulation was approved in July 2008 with an indication for idiopathic Parkinson disease. It received an indication for restless legs syndrome in May 2005.
The original formulation was shown in clinical trials to improve Unified Parkinson’s Disease Rating Scale (UPDRS) motor score by 26% compared to placebo, as well as a 19.4% decrease in the required dose of levodopa in those on the treatment compared to a 3% decrease with placebo.2 The extended-release therapy reduced the amount of off time experienced by patients with Parkinson disease by 2.1 hours per day on average, compared to 0.4 hours with placebo. In the EASE-PD trial, the adjusted mean difference in the reduction of off time was 1.7 hours.
For restless legs syndrome, in 3 clinical trials, the treatment showed mean changes in International RLS Rating Scale score of -13.5, -11.0, and -11.2 at 12 weeks, which was 3.7, 3.0, and 2.5, respectively, lower than placebo.
Mark J. Buchfuhrer, MD, a nationally recognized expert in RLS who has authored books and papers on the subject, told NeurologyLive in September 2018 that along with pramipexole, ropinirole hydrochloride is “probably the most commonly prescribed drug” for restless legs syndrome, used as first-line treatment.
NeurologyLive reached out to GlaxoSmithKline for comment, and a spokesperson said that “this was a business decision based on low and declining patient demand due to availability of numerous generic ropinirole alternatives. Patients should speak to their physician about an appropriate alternative if they are taking Requip IR or XL. This decision was made independently of any development programs.” REFERENCES
1. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. FDA website. Published December 19, 2018. accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Ropinirole+Hydrochloride+%28Requip%29+Tablets&st=d&tab=tabs-2. Accessed January 3, 2019.
2. Requip prescribing information. FDA label. gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Requip/pdf/REQUIP-PI-PIL.PDF. Updated February 2018. Accessed January 3, 2019.

Ropinirole: 7 things you should know

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Dizziness, dyskinesia (abnormal movements), headache, falls, nausea, abdominal pain, and sleepiness.
  • Dry mouth, increased sweating, joint aches and pains, vomiting, tremor, and infection have also been reported along with several other side effects.
  • Some people have reported spontaneously falling asleep during the day while taking ropinirole. Many had no prior warning, such as excessive drowsiness. Some of these events occurred more than one year after ropinirole initiation and resulted in accidents.
  • A slow upward titration of ropinirole is recommended over several weeks to lessen the risk of side effects developing. Ropinirole should also be discontinued slowly, over at least a week.
  • May cause a drop in blood pressure which may cause a person to fall over or become unconscious, especially when going from a sitting or lying down position to standing.
  • Some trials reported 10% of people developed hallucinations while taking ropinirole. The incidence was higher in people over the age of 65.
  • May cause or exacerbate pre-existing dyskinesia (abnormal voluntary movements) and promote impulsive behaviors (such as gambling, spending sprees, sexual urges).
  • May cause confusion and an elevated temperature on withdrawal; withdrawal should be done slowly on a doctor’s advice.
  • People with PD have a two to six-fold higher risk of developing melanoma compared with the rest of the population. It is unclear if this is a result of the disease or the medications used to treat PD.
  • People with severe kidney disease receiving hemodialysis should be given a reduced dose of ropinirole.
  • May not be suitable for some people including those with high or low blood pressure, heart disease, or with narcolepsy.
  • Some people taking ropinirole for RLS have reported a worsening of symptoms and an earlier onset of symptoms in the evening (or even in the afternoon). Reconsider ropinirole administration if this happens.
  • People who smoke may get less symptom relief from ropinirole because smoking increases the clearance of ropinirole.
  • Sometimes irreversible fibrotic complications (such as thickening of the inner layers of the lungs and pericarditis) have been associated with ropinirole.
  • May interact with several other drugs including estrogens, metoclopramide, and neuroleptics.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, .

July 15, 2008— — Russ Kelly of Yardley, Pa., was diagnosed with Parkinson’s disease about five years ago. Before that time, he had always been a social gambler and drinker.

But when he began treatment for the condition that affected his coordination, handwriting and speaking abilities, the 62-year-old noticed sudden changes in his behavior as well.

He began to think nothing of making the one-hour drive to the Atlantic City, N.J., casinos several times a week. “If I was by myself one night, I might just hop in the car and drive down there on an impulse,” Kelly says.

Though the thousands of dollars he lost at the blackjack tables were usually balanced by his winnings, his drinking spun out of control. He says he began slinging back tequila shots in addition to the one or two beers he typically drank after his weekly golf game.

One Tuesday night after golf, Kelly was arrested for driving under the influence, lost his license for 60 days and attended an alcohol rehabilitation program to clear his record.

“I could have killed somebody when I was driving,” Kelly says.

Though some might accuse Kelly of having a midlife crisis or decompensating due to his Parkinson’s diagnosis, he and his doctors attribute this impulsive behavior to his treatment — which included the drug Mirapex.

Mirapex and Requip are two of the drugs prescribed for Parkinson’s disease and Restless Legs Syndrome, or RLS. They both belong to a class of drugs known as dopamine agonists, which mimic the brain chemical known as dopamine.

Dopamine works in the brain’s movement and coordination centers, and it is also involved in the brain’s pleasure response by reinforcing behaviors that provide enjoyment — including drinking, drugs, sex and gambling.

So while drugs such as Mirapex can help alleviate the motor problems associated with Parkinson’s, they may also encourage such impulsive behaviors, some doctors say.

“It is believed that these medications overactivate the pleasure centers of the brain in an unregulated fashion,” says Dr. Melissa Nirenberg, assistant professor of neurology at Weill Cornell Medical Center in New York. “What has been almost as dramatic as the behaviors itself has been the fact that when you discontinue these medications, these behaviors stop.”

But Nirenberg and other doctors say that many neurologists and general practitioners who prescribe these drugs are unaware of the severity of the side effects, so patients are often left in the dark.

“There is still not enough physician awareness of this,” she says.

Strange Side Effects

More than 10 million prescriptions have been written for Mirapex since the drug was launched in 1997, according to Kate O’Connor, director of public relations for Boehringer Ingelheim Pharmaceuticals Inc., maker of Mirapex.

Information about the possible behavioral side effects, including gambling, compulsive eating and increased sex drive, has been included with the product for the past several years. But O’Connor says that it is difficult to estimate how many people may have experienced these side effects.

“For the vast majority of people who take these medications, compulsive behaviors do not occur, although these isolated incidences are, of course, very unfortunate,” she says.

Scientists have recently begun to quantify the behavioral changes associated with dopamine agonist drugs. In a study presented in late June at the International Congress of Parkinson’s Disease and Movement Disorders conference in Chicago, more than 13 percent of 3,090 Parkinson’s patients had a problem with compulsive gambling, buying, sex or binge-eating.

People who were taking either Mirapex or Requip had a two- to three-times greater chance of having one of the four impulse-control disorders.

“These disorders can often be devastating to people’s personal lives, financial lives, and even physical health,” says Dr. Daniel Weintraub, lead author of the study and assistant professor of psychiatry at the University of Pennsylvania School of Medicine.

Though Weintraub says that the benefits of the drug outweigh the negatives for most patients, he adds that “clinicians do have a responsibility to notify patients that these are potential side effects.”

Nirenberg even says she fears that these side effects are more prevalent than the study indicates, because only four of the many types of irregular behaviors were analyzed.

She says that her patients tend to have gender-based differences in side effects, with women experiencing more compulsive shopping and eating and men turning more to hypersexuality and gambling.

She says she also has patients who would have been overlooked in the study — a man who plays basketball compulsively for up to 36 hours at a time, and another who compulsively fishes. One spouse of a Parkinson’s patient had to put a padlock on the refrigerator because of the compulsive eating, she says.

These impulsive behaviors have “potentially devastating consequences,” Nirenberg says. “They have led to marital discord frequently … shopping and gambling have led to financial losses, and eating has led to weight gain and secondary medical consequences.”

But Are They Bad?

Dr. Eric Wassermann, neurologist and researcher at the Neurology Institute at the National Institutes of Health, says that the dopamine levels in the brain are normally lowered when a person experiences negative consequences of a behavior, such as gaining weight when overeating.

However, these medications keep the dopamine levels relatively constant. “If you are flooding the system, it is turned on constantly,” Wassermann says. “Probably these addictive behaviors become overly reinforcing, and punishments like losing money don’t work.”

And certain behaviors stimulated by the drugs, such as increased sexual drive, aren’t typically “punished” by drops in dopamine levels, Wassermann says.

“You just keep doing it over and over again and it keeps feeling good,” he says.

Robert Simpson, 59, of New York City, is one of Nirenberg’s patients who experienced an increased libido from the Mirapex. He began taking the drug in December 2005 and noticed an immediate change.

“I felt good,” Simpson says. “Not high, exactly, but I felt a little buzz. It was a new experience. I liked the feeling.”

He says he began buying pornography regularly, and masturbating two to three times a day.

“It wasn’t actually causing anyone any harm,” he says.

But when he told Nirenberg of this behavior, she immediately took him off the drug, just three months after he had started it.

“I don’t know if it was exactly the next day , but whatever was triggering my feelings of sexuality was diminished again,” he says.

Kelly also went off Mirapex just one week ago but says he hasn’t yet noticed a change in his impulsive behavior. He says he wishes that he had known about the side effects of the drug earlier.

“It needs to be clearly drilled into people who take the drug, and to their family, to look for behavioral changes,” he says.

Kelly says that his brother was the first to call him out, in a conversation that resulted in an argument. But his brother persisted, eventually calling Kelly’s doctor to let her know about the problems with the drinking and gambling.

“Things got so bad within the past couple of months,” Kelly says.

Though he had no idea that his brother thought the problem was serious enough to warrant a call to the doctor, Kelly says, “I’m happy he did.”

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