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Recommendations for selecting muscle relaxants for musculoskeletal conditions such as low back pain, fibromyalgia, tension headaches, and myofascial pain syndrome are reviewed in an article published in the August 1 issue of American Family Physician.

“Prescription rates for nonspecific back pain revealed that skeletal muscle relaxants accounted for 18.5 percent of prescriptions compared with 16.3 percent for NSAIDs [nonsteroidal anti-inflammatory drugs] and 10 percent for cyclooxygenase-2 inhibitors,” write Sharon See, PharmD, BCPS, and Regina Ginzburg, PharmD, from St. John’s University College of Pharmacy and Allied Health Professions in Jamaica, New York. “Because of the high rate of prescribing skeletal muscle relaxants, an understanding of the risks and benefits of this class of drugs is vital. This article presents evidence regarding the use of antispasmodic skeletal muscle relaxants for various musculoskeletal conditions, and appropriate drug selection if a skeletal muscle relaxant is required.”

Despite the widespread use of skeletal muscle relaxants for treatment of musculoskeletal conditions, data supporting this practice come primarily from studies with methodologic limitations. Treatment goals for low back or neck pain, fibromyalgia, tension headaches, and myofascial pain syndrome include alleviation of muscle pain and improvement in functional ability allowing return to work or to customary activities.

Skeletal muscle relaxants have not been shown to be superior to acetaminophen or NSAIDs for low back pain, although systematic reviews and meta-analyses support short-term use of skeletal muscle relaxants for relief of acute low back pain in patients who do not respond to or tolerate NSAIDs or acetaminophen. Existing recommendations for treating tension headaches are similar.

There are 2 main categories of skeletal muscle relaxants: antispastic (such as baclofen or dantrolene) for conditions such as cerebral palsy and multiple sclerosis and antispasmodic agents for musculoskeletal conditions. Evidence is extremely limited to support the use of antispastic agents for musculoskeletal conditions, for which an antispasmodic agent is typically more appropriate.

The most commonly prescribed antispasmodic agents are carisoprodol, cyclobenzaprine, metaxalone, and methocarbamol.

A meta-analysis of cyclobenzaprine showed that it was superior to placebo for treating fibromyalgia but that it was not as effective as antidepressants. Recent guidelines regarding treatment of fibromyalgia recommend a comprehensive approach using tramadol, antidepressants, and/or a heated pool, with or without exercise.

In comparison trials, no single skeletal muscle relaxant has been proven to be superior to another. The most widely studied agent is cyclobenzaprine, with demonstrated efficacy for various musculoskeletal conditions but with significant sedation. Tizanidine, which also causes marked sedation, or cyclobenzaprine may be useful in patients with insomnia because of severe muscle spasms.

All skeletal muscle relaxants are associated with adverse effects including dizziness and drowsiness, and the potential for these adverse effects should be clearly explained to the patient. Although methocarbamol and metaxalone are less sedating than tizanidine and cyclobenzaprine, evidence is limited for their efficacy. A specific skeletal muscle relaxant should be chosen according to consideration of adverse effect profile, patient preference, potential for abuse, and possible interactions with other prescribed medications because comparable efficacy data are limited.

Carisoprodol is typically prescribed at a dose of 350 mg 4 times daily, but it is not recommended for children younger than 12 years. Adverse events include dizziness, drowsiness, headache, rare idiosyncratic reactions (mental status changes, transient quadriplegia, and temporary loss of vision) after the first dose that may require hospitalization, and allergy-type reactions that may occur after the first to fourth dose. Physical or psychological dependence may occur, and withdrawal symptoms may occur when carisoprodol is discontinued. When combined with benzodiazepines, barbiturates, codeine or its derivatives, or other muscle relaxants, carisoprodol may contribute to respiratory depression.

Starting dose for cyclobenzaprine is 5 mg 3 times daily, which may be increased to 10 mg 3 times daily. Adverse effects include anticholinergic effects of drowsiness, dry mouth, urinary retention, and increased intraocular pressure. Rare but serious adverse events may include arrhythmias, seizures, or myocardial infarction. It should be avoided in older patients and in patients with glaucoma, and there may be possible drug interactions with cytochrome P450 inhibitors.

Metaxalone is prescribed at 800 mg 3 to 4 times daily and is not recommended in children younger than 12 years. Drowsiness, dizziness, headache, and nervousness are common adverse effects. Rare adverse events may include leukopenia or hemolytic anemia; elevation in liver function tests; or nausea, vomiting, and diarrhea. Paradoxic muscle cramps may also occur.

Methocarbamol is given at a dosage of 1500 mg 4 times daily for the first 2 to 3 days and is then reduced to 750 mg 4 times daily. Use of this drug may be associated with black, brown, or green urine; mental status impairment; or possible exacerbation of myasthenia gravis symptoms.

Specific clinical recommendations for practice, and their accompanying level of evidence rating, are as follows:

* Skeletal muscle relaxants are not considered first-line therapy for musculoskeletal conditions (level of evidence, C).
* For acute low back pain, skeletal muscle relaxants may be used as adjunctive therapy (level of evidence, B).
* For acute low back pain, antispasmodic agents should be used short term (2 weeks; level of evidence, C).
* Evidence to date does not clearly support the superiority of 1 skeletal muscle relaxant to another for musculoskeletal spasms (level of evidence, B).
* Specific drug profile and individual patient situation should guide the choice of skeletal muscle relaxant (level of evidence, C).

“Despite their popularity, skeletal muscle relaxants should not be the primary drug class of choice for musculoskeletal conditions,” Drs. See and Ginzberg write. “The American Pain Society and the American College of Physicians recommend using acetaminophen and…NSAIDs as first-line agents for acute low back pain and reserving skeletal muscle relaxants as an alternative treatment option. This recommendation is based on available literature, which shows skeletal muscle relaxants are better than placebo, but not more effective than NSAIDs in patients with acute back pain.”

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Sedation is the most commonly reported adverse effect of muscle relaxant medications. These drugs should be used with caution in patients driving motor vehicles or operating heavy machinery. More absolute contraindications do exist to the use of carisoprodol, cyclobenzaprine, and diazepam. Rare idiosyncratic reactions have also been reported to carisoprodol and its metabolites such as meprobamate. Benzodiazepines have potential for abuse and their use should be avoided. By initially prescribing muscle relaxants at bedtime, the physician might take advantage of their sedative effects and minimize daytime drowsiness.

These agents have been found to be effective when used either alone or in combination with an analgesic/anti-inflammatory agent within seven days of symptom onset. The prescribing physician should monitor patients receiving these medications and tailor dosages in an attempt to minimize the drowsiness and sedation often associated with their use. The use of benzodiazepines does not appear to offer any significant benefit to patients experiencing acute low back pain. Further research is needed before the role of baclofen and dantrolene sodium in the treatment of muscle spasm of local origin can be more clearly defined.

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Strains, sprains, and other muscle injuries can result in pain, stiffness, and muscle spasms. Muscle relaxants do not heal the injuries, but they do relaxmuscles and help ease discomfort and stop muscle spasms. The muscle relaxantcyclobenzaprine (Flexeril) is also sometimes used to treat fibromyalgia, a condition that involves aches, stiffness, and fatigue.

Muscle relaxants work by acting on the central nervous system. In the UnitedStates, they are available only with a physician’s prescription. Examples ofmuscle relaxants are carisoprodol (Soma), chlorzoxazone (Parafon Forte DSC),cyclobenzaprine (Flexeril), and methocarbamol (Robaxin). Most come only in tablet form. However, methocarbamol (Robaxin) is available in both tablet and injectable forms. Some muscle relaxants are available in Canada without a prescription.

Muscle relaxants are usually prescribed along with rest, exercise, physical therapy, or other treatments. Although the drugs may provide relief, they should never be considered a substitute for these other forms of treatment. Thesedrugs may make the injury feel so much better that one is tempted to go backto normal activity, but doing too much too soon can actually make the injuryworse.

Muscle relaxants work quite well for relieving muscle pain due to injuries, but are not effective for other types of pain. Some people feel drowsy, dizzy,confused, lightheaded, or less alert when using muscle relaxants drugs. These drugs may also cause blurred vision, clumsiness, or unsteadiness.

Because muscle relaxants work on the central nervous system, they may add tothe effects of alcohol and other drugs that slow down the central nervous system. They may also add to the effects of anesthetics, including those used for dental procedures. For this reason, anyone who takes these drugs should notdrive, operate machinery, or do anything else that might be dangerous untilthey have found out how the drugs affect them.

People with certain medical conditions or who are taking certain other medicines can have problems if they take muscle relaxants. Diabetes should be awarethat the metaxalone (Skelaxin) may cause false test results on one type of test for sugar in the urine. People with epilepsy should be cautioned that taking the muscle relaxant methocarbamol may increase the likelihood of seizures.

Anyone who has allergies, who is breastfeeding has kidney disease, has suffered a recent heart attack or irregular heartbeat, has an overactive thyroid gland, hepatitis or liver disease, is a current or former drug or alcohol abuser, has glaucoma, or has problems with urination should discuss their condition with their doctor before taking muscle relaxants.

The most common side effects or muscle relaxants are vision changes, such asdouble vision or blurred vision; dizziness; lightheadedness; drowsiness; anddry mouth. These problems usually go away as the body adjusts to the drug anddo not require medical treatment. Methocarbamol and chlorzoxazone may causeharmless color changes in urine –orange or reddish-purple with chlorzoxazoneand purple, brown, or green with methocarbamol. The urine will return to itsnormal color when the patient stops taking the medicine.

Less common side effects, such as stomach cramps or pain, nausea and vomiting, constipation, diarrhea, hiccups, clumsiness or unsteadiness, confusion, nervousness, restlessness, irritability, flushed or red face, headache, heartburn, weakness, trembling, and sleep problems also may occur and do not need medical attention unless they do not go away or they interfere with normal activities.

More serious side effects are not common, but may occur. Anyone who experiences breathing problems, facial swelling, fainting, unusually fast or unusuallyslow heartbeat, fever, tightness in the chest, rash, itching, hives, burning, stinging, red, or bloodshot eyes, or unusual thoughts or dreams after taking muscle relaxants should seek medical help promptly

The muscle relaxant chlorzoxazone (Parafon Forte DSC) has caused serious, life-threatening liver problems in some people. The reaction is rare, but anyonetaking the drug should stop taking it and notify his or her physician immediately if any of these symptoms occur: fever, rash, loss of appetite, nausea,vomiting, fatigue, pain in the upper right part of the abdomen, dark urine, or yellow skin or eyes.

Muscle relaxants may interact with some other medicines. When this happens, the effects of one or both of the drugs may change or the risk of side effectsmay be greater. Anyone who plans to take muscle relaxants should let the physician know all other medicines, including over-the-counter or nonprescription medicines, that he or she is taking.

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Soma is used for treating discomfort associated with certain painful muscle conditions. It is usually used along with rest and physical therapy.

Soma is a skeletal muscle relaxant. It works in the brain and spinal cord to relax the muscles. It also causes drowsiness.

Rarely, some patients have experienced an unexpected reaction within minutes or hours after taking Soma. Contact your doctor or seek medical care right away if you develop severe weakness, paralysis of the arms or legs, severe dizziness, loss of coordination, vision changes (eg, loss of vision, double vision), joint pain, or mental or mood changes (eg, agitation, confusion, disorientation).

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The present invention relates to the delivery of muscle relaxants through an inhalation route. Specifically, it relates to aerosols containing a muscle relaxant that is used in inhalation therapy. In a composition aspect of the present invention, the aerosol comprises particles comprising at least 5 percent by weight of muscle relaxant. In a method aspect of the present invention, a muscle relaxant is delivered to a mammal through an inhalation route.

The method comprises:

a) heating a composition, wherein the composition comprises at least 5 percent by weight of a muscle relaxant, to form a vapor.
b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles, which is inhaled by the mammal.

In a kit aspect of the present invention, a kit for delivering a muscle relaxant through an inhalation route to a mammal is provided which comprises:

a) a composition comprising at least 5 percent by weight of a muscle relaxant
b) a device that forms a muscle relaxant containing aerosol from the composition, for inhalation by the mammal.

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Soma is a muscle relaxer that works by blocking pain sensations between the nerves and the brain.

Soma is used together with rest and physical therapy to treat injuries and other painful musculoskeletal conditions. The Carisoprodol’s treating mechanism provides blocking of electrical communication among nerves in the reticular formation of the brain. It also blocks this kind of communication in the spinal cord.

Soma is usually taken three times per day and before going to bed by one tablet (350 mg). Children under 12 years should not be treated with this product. To prevent the stomach disorder, take Carisoprodol with milk or food.

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Muscle spasm of local origin needs to be clinically differentiated from spasticity and sustained muscle contraction in the setting of the central nervous system (CNS) and upper motor neuron injury. Baclofen (Lioresal®) and dantrolene sodium (Dantrium®) are two agents whose use is indicated in the setting of spasticity of CNS etiology. Dantrolene sodium is of particular interest, as its mechanism of action is purely at the muscular level where it serves to inhibit the release of calcium form the sarcoplasmic reticulum.

Casale studied the effectiveness of dantrolene sodium, 25-mg daily, in the treatment of low back pain and found patients to demonstrate significant improvements in visual analogue scores, pain behavior, and electromyographic (EMG) evaluations of “antalgic reflex motor unit firing,” when compared with the placebo group. The findings of this study are interesting in that they demonstrate improvement secondary to a pure muscle relaxant, which does not possess other outside anti-nociceptive properties.

Baclofen is a derivative of gamma-aminobutryic acid (GABA) and is believed to inhibit mono and polysynaptic reflexes at the spinal level. Treatment with baclofen was compared to placebo in a double blind, randomized study of 200 patients with acute low back pain. Patients with initially severe discomfort were found to benefit from baclofen, 30- to 80-mg daily, on days four and ten of follow up. Forty-nine percent of treatment patients complained of sleepiness, 38% of nausea, and 17% discontinued treatment.

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In an attempt to determine the mechanism of action of carisoprodol (Soma®) in the treatment of low back pain, a double blind study was carried out comparing its effectiveness to that of a sedative control, butabarbital (a sedative), and a placebo in the treatment of 48 laborers with acute lumbar pain. Carisoprodol was found to be significantly more effective in providing both subjective pain relief and objective improvements in range of motion when evaluated by finger to floor testing. The results of this study suggest that the effects of carisoprodol are not secondary to its sedative effects alone.

In 1989, Basmajian compared the effectiveness of cyclobenzaprine (Flexeril®) alone with diflunisal (Dolobid®), placebo, and a combination of cyclobenzaprine and diflunisal in the treatment of acute low back pain and spasm. During the ten-day study period, the combined treatment group demonstrated significantly superior improvements in global ratings on day four, but not on day two or seven. This study suggested some effectiveness of combined analgesic and muscle relaxant therapy when utilized early in the initial week of pain onset.

Borenstein compared the effects of combined cyclobenzaprine and naproxen (Naprosyn®) with naproxen alone and also found combination therapy to be superior in reducing tenderness, spasm, and range of motion in patients presenting with ten days or less of low back pain and spasm. Adverse effects, predominantly drowsiness, were noted in 12 of 20 in the combined group and only four of 20 treated with naproxen alone.

Cyclobenzaprine and carisoprodol were compared in the treatment of patients with acute thoracolumbar pain and spasm rated moderate to severe and of no longer than seven days duration. Both drugs were found to be effective, without significant differences between the treatment groups. Significant improvements were noted in physician rated mobility and in patients’ visual analogue scores on follow up days four and eight. While 60% of patients experienced adverse effects in the form of drowsiness or fatigue, these differences were not significantly different between groups, and only eight percent of patients from each group discontinued treatment.

Baratta found cyclobenzaprine, 10-mg t.i.d. (three times per day), superior to placebo in a randomized, double blind study of 120 patients with acute low back pain presenting within five days of symptom onset. Significant improvement was noted in range of motion, tenderness to palpation, and pain scores on follow up days two through nine. Sixty percent of treatment group patients reported drowsiness or dizziness compared with 25% of those in the placebo group.

In an earlier study, diazepam (Valium®) was found to offer no significant subjective or objective benefit, when compared to placebo, in patients treated for low back pain. Carisoprodol was found to be superior to diazepam in the treatment of patients with “at least moderately severe” low back pain and spasm of no longer than seven days duration. In this study, the overall incidence of adverse reactions was higher in the diazepam treated group but was not of statistical significance.

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The muscle relaxing properties of “muscle relaxants” arise not from direct activity at the muscular or neuromuscular junction level but rather from an inhibition of more central polysynaptic neuronal (nerve cells that end in synapses) events. These agents have also been shown in some studies to demonstrate superior analgesia to either acetaminophen or aspirin, and it remains uncertain if muscle spasm is a prerequisite to their effectiveness as analgesics.

Muscle relaxants are often prescribed in the treatment of acute low back pain in an attempt to improve the initial limitations in range of motion from muscle spasm and to interrupt the pain-spasm-pain cycle. Limiting muscle spasm and improving range of motion will prepare the patient for therapeutic exercise.

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Muscle relaxants are not really a class of drugs, but rather a group of different drugs that each has an overall sedative effect on the body. These drugs do not act directly on the muscles, rather they act centrally (in the brain) and are more of a total body relaxant.

Typically, muscle relaxants are prescribed early in a course of back pain, on a short-term basis, to relieve low back pain associated with muscle spasms. There are several types of muscle relaxant medications that are commonly used to treat low back pain:

* Carisoprodol (Soma). This drug’s dosage is 350mg every eight hours as needed for muscle spasm. Soma is typically prescribed on a short-term basis and may be habit-forming, especially if used in conjunction with alcohol or other drugs that act on the mind.
* Cyclobenzaprine (Flexeril). This medication can be used on a longer-term basis and actually has a chemical structure related to some antidepressant medications, although it is not an antidepressant. Usually it is prescribed as 10mg every six hours as needed to relieve low back pain associated with muscle spasm, or it can also be prescribed as 10mg at night as needed to help with difficulty sleeping. Flexeril can impair mental and physical function, and may lead to urinary retention in males with large prostates.
* Diazepam (Valium). Valium is usually limited to one to two weeks of use, and the typical dosage is 5-10mg every six hours as needed to relieve low back pain associated with muscle spasm. Because of its habit-forming potential, and because it changes sleep cycles and makes it very difficult to sleep after stopping the drug, Valium should not be used long term. Patients should also note that Valium is a depressant and can worsen depression associated with chronic pain.

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