Baclofen: Uses, Dosage, Side Effects, Withdrawal Risks and Cost

Baclofen is a prescription muscle relaxant and antispastic drug. In the US it is approved to relieve spasticity, the stiff, jerky, overactive muscles caused by multiple sclerosis, and the label says it may also be of some value after spinal cord injuries and in other spinal cord diseases. The newer US labels give its initial US approval as 1977.

This guide covers what baclofen is used for and what it is not approved for, the forms sold in the US, the label dosing schedule, the side effects with the rates printed on the label, why it must never be stopped suddenly, kidney problems, alcohol and other interactions, overdose, pregnancy, the intrathecal pump version, its legal status, the off-label use for alcohol use disorder and what the trials found, and what it costs. We sell Indian baclofen brands, so we have a commercial interest. Every number below comes from US labels on DailyMed, FDA and federal databases, PubMed abstracts and a French regulator document, all listed under Sources.

The short answer

Baclofen relaxes spastic muscles by acting on the spinal cord. The US labels start adults at 5 mg three times a day and raise the dose every 3 days, with a maximum of 80 mg a day (20 mg four times a day). The label says the best dose is usually between 40 and 80 mg a day.

The most common side effect is drowsiness, reported in 10% to 63% of patients across studies. Dizziness and weakness each run 5% to 15%. The most serious risk is sudden stopping: the label says hallucinations and seizures have occurred on abrupt withdrawal, and newer labels add high fever, rebound spasticity and, in rare cases, organ failure and death. Baclofen is not a DEA controlled substance, and it is not FDA approved for alcohol use disorder, although France approved it for that purpose in 2018.

What baclofen is and how it works

Baclofen is 4-amino-3-(4-chlorophenyl)-butanoic acid, a chemical relative of GABA, the brain and spinal cord's main calming messenger. The newer US labels say it may work by stimulating the GABA-B receptor subtype. It reduces both monosynaptic and polysynaptic reflexes at the spinal level, which is why it calms spasms that start in the spinal cord.

The labels are candid that the precise mechanism is not fully understood. They also say baclofen has general central nervous system (CNS) depressant effects: sedation, sleepiness, unsteadiness and, at high levels, slowed breathing. That is the root of most of its side effects and of the warning about alcohol.

Baclofen is different from the drugs people take for a strained back. Cyclobenzaprine, for example, is labelled for short-term muscle spasm from injuries. Baclofen is labelled for spasticity of neurological origin, which is often a long-term condition. Our muscle relaxer comparison sets the main options side by side.

What baclofen is used for

The generic baclofen tablet labels say baclofen is "useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity."

In plain terms, that covers:

• Flexor spasms: sudden involuntary bending of the legs or arms, often painful.
• Clonus: rhythmic jerking of a muscle, often at the ankle.
• Muscular rigidity: stiffness that makes walking, transfers and sleep harder.

The label adds that patients "should have reversible spasticity so that baclofen treatment will aid in restoring residual function," and that baclofen "may also be of some value in patients with spinal cord injuries and other spinal cord diseases."

What baclofen is not approved for

The US tablet labels set out clear limits:

• Baclofen is "not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders."
• "The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions."
• On stroke, the warnings add: "Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug."
• "Safety and effectiveness in pediatric patients below the age of 12 years have not been established."

Some Indian pharmacy listings, such as the Truemeds page for Liofen XL, describe baclofen as a treatment for cerebral palsy or stroke. That is not what the US labels say. None of the US oral baclofen labels we read lists alcohol use disorder, back pain or anxiety as an indication either; the alcohol evidence is covered further down.

Baclofen forms sold in the US

Baclofen comes in more forms than most people expect. From openFDA's Drugs@FDA data and the DailyMed labels we read on 30 October 2026:

Form	Strengths	Examples
Oral tablets	5, 10, 15 and 20 mg	Generic baclofen tablets USP (many makers)
Oral solution	5 mg/5 mL and 10 mg/5 mL	Ozobax DS 10 mg/5 mL; generic solutions
Oral suspension	25 mg/5 mL	Fleqsuvy; generic suspension
Oral granules	Single-dose packets	Lyvispah
Intrathecal injection	0.05 to 2 mg/mL	Lioresal Intrathecal, Gablofen, generics

The liquid and granule forms exist for people who cannot swallow tablets or who take medicines through a feeding tube. They are not interchangeable by volume: Fleqsuvy's label carries a warning that it is "a concentrated baclofen formulation of 25 mg/5 mL (5 mg/mL)", five times stronger per mL than the 5 mg/5 mL solution. Drugs@FDA lists the original 5 mg/5 mL Ozobax and the original Lyvispah application's products as discontinued, although a September 2026 Lyvispah label from a different company is on DailyMed.

Is there an extended-release baclofen?

Not in the US, as far as the federal data show. None of the baclofen products in openFDA's Drugs@FDA data, and none of the baclofen labels listed on DailyMed on 30 October 2026, is an extended-release form. US baclofen is an immediate-release drug taken three or four times a day.

Liofen XL, sold by Sun Pharma in India, is a capsule; Indian listings show 10, 20, 30 and 40 mg, and we stock 10, 20 and 30 mg. It is not an FDA-approved product. We could not read an Indian label for Liofen XL that states its release profile or dosing interval, so we do not make claims about how often it is taken. If you are prescribed it, follow your prescriber and the carton, and do not swap it milligram for milligram with plain tablets without asking.

Baclofen dosage: the label titration schedule

Baclofen is started low and raised in steps, because sleepiness and weakness are common early. The US tablet labels say "the determination of optimal dosage requires individual titration" and suggest this schedule:

Days	Dose	Total per day
1 to 3	5 mg three times a day	15 mg
4 to 6	10 mg three times a day	30 mg
7 to 9	15 mg three times a day	45 mg
10 to 12	20 mg three times a day	60 mg
After that, if needed	Up to 20 mg four times a day	80 mg maximum

Three further points from the label:

• The optimum effect is "usually between 40 mg to 80 mg daily."
• "The lowest dose compatible with an optimal response is recommended."
• "If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug." Not stopped, withdrawn slowly.

Your prescriber may go slower than this, especially if you are older, have kidney problems or feel very drowsy. The label schedule is a suggestion, not a race.

Baclofen 10 mg and other tablet strengths

A scored 10 mg tablet can be split to give the 5 mg starting dose. The Upsher-Smith label describes its 10 mg tablet as "white, round tablets with functional scoring", and its 20 mg tablet looks the same with a different imprint. Tablet appearance varies by maker, so check your own pharmacy label rather than relying on a description.

The US tablet strengths in the federal data are 5, 10, 15 and 20 mg. There is no 25 mg baclofen tablet among them. Indian brands such as Liofen 25 and Bacloheal 25 are 25 mg tablets, which do not fit the US schedule neatly: one tablet three times a day is 75 mg, close to the 80 mg ceiling. If you are moving from US tablets to a 25 mg product, ask your prescriber how to do it rather than working it out alone.

How fast baclofen works and how long it lasts

Baclofen is absorbed quickly. From the pharmacokinetic sections of the newer US labels:

Product	Time to peak level	Half-life
Lyvispah granules	About 1 hour	About 5.5 hours
Ozobax oral solution	About 0.75 hours	About 5.7 hours
Fleqsuvy suspension	About 1 hour	About 5.6 hours

Each of those labels says bioavailability matched baclofen tablets at a 20 mg dose, so tablets behave in a similar way. A half-life of five to six hours is the reason baclofen is taken three or four times a day. The labels also note "relatively large intersubject variation in absorption and/or elimination", which is one reason doses are adjusted person by person.

Food has a small effect. The Lyvispah label says a high-fat meal cut overall exposure by 10% and the peak level by 29% compared with fasting. Baclofen can be taken with or without food; being consistent helps.

Baclofen side effects: the label rates

The US labels list these adverse reactions in patients treated with baclofen for spasticity. Each figure is a range across studies:

Adverse reaction	Percent of patients
Drowsiness	10% to 63%
Dizziness	5% to 15%
Weakness	5% to 15%
Nausea	4% to 12%
Confusion	1% to 11%
Low blood pressure	0% to 9%
Headache	4% to 8%
Insomnia	2% to 7%
Constipation	2% to 6%
Urinary frequency	2% to 6%
Fatigue	2% to 4%

The one placebo-controlled number on the label is for drowsiness: in a controlled study of 175 patients, transient drowsiness was seen in 63% of those on baclofen and 36% of those on placebo. The label calls the drowsiness "transient", and it is often worst in the first days and after each dose increase.

Weakness deserves a word. Some people with multiple sclerosis or spinal cord injury rely on a degree of leg stiffness to stand and walk. The label warns that baclofen "should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function." Too much relaxation can make walking harder, not easier.

Less common side effects

The labels list other reactions without rates, describing many of them as rare:

• Nervous system and mood: euphoria, excitement, depression, hallucinations, tingling, muscle pain, ringing in the ears, slurred speech, poor coordination, tremor, rigidity, dystonia, unsteadiness, blurred or double vision, seizures.
• Heart and breathing: shortness of breath, palpitations, chest pain, fainting.
• Stomach: dry mouth, loss of appetite, taste changes, abdominal pain, vomiting, diarrhea.
• Urinary and sexual: bedwetting, urinary retention, painful urination, impotence, inability to ejaculate, night-time urination, blood in the urine.
• Other: rash, itching, ankle swelling, sweating, weight gain, nasal congestion.

The labels note that some nervous system and urinary symptoms may come from the underlying disease rather than the drug. A few patients have shown raised liver enzymes (SGOT), alkaline phosphatase or blood sugar.

One finding surprises people: ovarian cysts. The label says cysts were found by examination in about 4% of multiple sclerosis patients treated with baclofen for up to a year, that most disappeared while patients continued the drug, and that cysts occur spontaneously in about 1% to 5% of women in general.

Baclofen withdrawal: never stop suddenly

This is the most important safety point for oral baclofen. The generic tablet labels say: "Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued."

The newer labels (Lyvispah, Ozobax DS, Fleqsuvy) go further: "Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death."

Their patient counselling sections say early symptoms of withdrawal "may include increased spasticity, itching, and tingling of extremities." In practice:

• Do not stop baclofen on your own, even if you think it is not working.
• Do not let a prescription run out. Order refills well before the last week.
• If you are admitted to hospital, unable to swallow or vomiting, tell the team you take baclofen and how much.
• If you are being taken off it, your prescriber will reduce the dose step by step.

The same logic applies to other drugs that need a taper. Our pregabalin withdrawal guide covers another example.

Kidney problems and older adults

Baclofen leaves the body mainly through the kidneys, unchanged. The labels say: "Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage."

The US labels do not give a dose table by kidney function. That means the adjustment is a prescriber's judgement, usually a lower starting dose and smaller steps. The newer labels add that the risk of adverse reactions "may be greater in patients with impaired renal function" and that, because older people are more likely to have reduced kidney function, "it may be useful to monitor renal function." For an older adult, starting "at the low end of the dosing range" is the label's general advice.

If you have kidney disease or are on dialysis, make sure the prescriber knows before baclofen is started or the dose is raised. New confusion or heavy sleepiness in someone with poor kidney function should be reported promptly.

Who should be careful with baclofen

The only contraindication on the US labels is hypersensitivity to baclofen. The warnings and precautions sections ask for caution in these groups:

Group	What the label says
Stroke	Has not significantly benefited patients with stroke; poor tolerability
Psychotic disorders, schizophrenia, confusional states	Use with caution; keep under careful surveillance, as exacerbations have been observed
Autonomic dysreflexia	Use with caution; painful stimuli or abrupt withdrawal may trigger an episode
Epilepsy	Deterioration in seizure control has been reported; monitor clinical state and EEG
People who rely on spasticity to stand or walk	Use with caution
Kidney impairment	Use with caution; the dose may need to be reduced

Driving, alcohol and other CNS depressants

The labels tell patients to avoid driving or operating machinery "when starting LYVISPAH or increasing the dosage until they know how the drug affects them," and warn that "the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants."

Common CNS depressants include opioid pain medicines, benzodiazepines, sleeping tablets, sedating antihistamines, gabapentin and pregabalin, and other muscle relaxants such as tizanidine or cyclobenzaprine. The labels do not forbid these combinations, but the sedation adds up. Tell your prescriber and pharmacist about everything you take, including over-the-counter sleep aids, and keep alcohol low or avoid it, especially while the dose is changing.

Baclofen overdose

The generic tablet labels list the signs of overdose as "vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures." The Lyvispah label adds lightheadedness and dizziness, and describes hypotonia "progressing to loss of consciousness."

The labels' treatment advice is for medical teams: protect the airway, support breathing and empty the stomach where appropriate, and do not use respiratory stimulants. For anyone else, the action is simple: if someone may have taken too much baclofen, especially with alcohol or other sedatives, call emergency services or a poison control center straight away. Keep baclofen away from children; the tablet labels call for child-resistant closures.

Pregnancy, breastfeeding and children

Pregnancy. There are no adequate human data. In rats, baclofen at about 13 times the maximum human dose increased omphaloceles (a ventral hernia) at a dose that also reduced the mothers' food intake and weight gain; this was not seen in mice or rabbits. The older tablet labels say baclofen "should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus."

Withdrawal in newborns. All the oral labels warn that "withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy," including increased muscle tone, tremor, jitteriness and seizure. If baclofen is continued in pregnancy, the labels say to "gradually reduce the dose and discontinue baclofen before delivery," or, if that is not feasible, to warn the parents.

Breastfeeding. The older tablet labels say it is not known whether baclofen passes into milk. The newer Lyvispah label says that "at recommended oral doses, baclofen is present in human milk" and that withdrawal symptoms can occur in breastfed infants when the mother stops baclofen or stops breastfeeding. Discuss this with your doctor before delivery.

Children. Safety and effectiveness of oral baclofen below age 12 have not been established. The intrathecal products are labelled from age 4.

Intrathecal baclofen pumps: a separate product

Intrathecal baclofen (Lioresal Intrathecal, Gablofen and generics) is delivered directly into the fluid around the spinal cord through an implanted pump. Gablofen's label indicates it for severe spasticity in adults and children aged 4 and above, and for spasticity of spinal cord origin reserves it for patients who do not respond to oral baclofen or cannot tolerate its CNS side effects at effective doses. Patients must first respond to a test dose.

The intrathecal labels carry a boxed warning, "WARNING: DO NOT DISCONTINUE ABRUPTLY". It reads in part: "Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death." It stresses pump programming, refill schedules and alarms, and names spinal cord injury at T-6 or above and communication difficulties as higher-risk situations.

Intrathecal baclofen is given only by specialist teams, and nothing about it can be bought online. It is included here because it shares the withdrawal danger, which is even sharper with a pump.

Is baclofen a controlled substance?

No. Baclofen does not appear in any of the federal controlled substance schedules in 21 CFR Part 1308 (Schedules I to V, sections 1308.11 to 1308.15), checked in the eCFR text dated 1 October 2026. By comparison, the muscle relaxant carisoprodol (Soma) is listed in Schedule IV in section 1308.14.

Not controlled does not mean available without a prescription. Baclofen is a prescription-only drug in the US, and the generic tablet labels we read are marked "Rx only". It also does not mean it is free of dependence-type problems: the withdrawal reactions described above are the reason it must be tapered. State rules can differ from federal schedules, so check locally if this matters to you.

Baclofen for alcohol use disorder: what the trials found

Baclofen is not FDA approved for alcohol use disorder, and none of the US labels lists it as an indication. In France it was widely prescribed off label for this before approval, at doses of up to 300 and even 400 mg a day according to a 2025 French review, far above the US maximum of 80 mg a day. The trials have given mixed answers.

Study	Design and dose	Main result
BACLAD, Muller 2015	56 randomized; titrated 30 to 270 mg/day; 12-week high-dose phase	Total abstinence 68.2% (15 of 22) vs 23.8% (5 of 21) on placebo, p=0.014
Beraha 2016	151 randomized; up to 150 mg (mean 93.6 mg) or 30 mg vs placebo	No difference in time to first relapse; frequent dose-related fatigue, sleepiness, dry mouth
ALPADIR, Reynaud 2017	320 randomized after detox; target 180 mg/day; 7-week titration plus 17-week maintenance	Abstinent for 20 weeks: 11.9% vs 10.5% on placebo, not significant; craving fell more on baclofen

The 2023 Cochrane review (Agabio and colleagues) pooled 17 randomized trials with 1,818 participants. Compared with placebo, baclofen probably reduced the risk of relapse (risk ratio 0.87, 95% CI 0.77 to 0.99; moderate-certainty evidence) and increased the percentage of days abstinent by 9.07 points (95% CI 3.30 to 14.85; high-certainty evidence), mainly among people who had been detoxified first. It probably did not reduce heavy drinking days or drinks per drinking day. Fatigue, dizziness, sleepiness, dry mouth, tingling and muscle stiffness were more common on baclofen.

A 2025 dose-response meta-analysis (Kotake and colleagues, 14 trials, 1,344 patients) found that doses up to 50 to 60 mg a day were associated with more abstinent days and less craving, that higher doses raised dropout due to adverse events, and that doses above 60 mg a day could not be reliably evaluated.

France. A 2025 review by French addiction specialists says France has been, since 2018, the only country to approve baclofen for alcohol dependence, and only to support reduced drinking. An ANSM-distributed prescriber guide for Baclofene Zentiva 10 mg (October 2021) restricts that use to adults with alcohol dependence and high-risk drinking (more than 60 g a day for men or 40 g for women) after other medicines have failed, recommends specialist addiction assessment above 80 mg a day, and strongly recommends not exceeding 300 mg a day.

Bottom line: there is some evidence for keeping people abstinent, it is weaker for cutting down, and the high doses used carry real sedation risk, made worse by alcohol itself. This is a decision for an addiction specialist, not self-treatment.

Baclofen vs other muscle relaxers

Other muscle relaxants, such as tizanidine, cyclobenzaprine and carisoprodol, differ from baclofen in how they work, how sedating they are, their interactions and their legal status. We cover this in our muscle relaxers compared guide, the tizanidine dosage and interactions guide and the cyclobenzaprine dosage guide, so this page sticks to baclofen. Related pain and muscle spasm guides are on our chronic pain page.

What baclofen costs in the US

Generic baclofen tablets are among the cheapest prescription drugs in the US. The federal NADAC survey reports what retail pharmacies pay to buy a drug, not what patients pay at the counter. Latest values, week of 28 October 2026, median across the generic NDC rows reported that week:

Product	NADAC per unit
Baclofen 5 mg tablet	$0.06842 per tablet
Baclofen 10 mg tablet	$0.03260 per tablet
Baclofen 15 mg tablet	$1.60828 per tablet
Baclofen 20 mg tablet	$0.05451 per tablet
Baclofen 5 mg/5 mL solution	$1.03784 per mL
Baclofen 10 mg/5 mL solution	$1.98154 per mL
Baclofen 25 mg/5 mL suspension	$3.70231 per mL

To put that in monthly terms: 60 mg a day as 20 mg three times a day is 90 tablets a month, which works out at $4.91 at NADAC. The same dose taken as 10 mg tablets is 180 tablets, $5.87. Your own price depends on your pharmacy's markup and your insurance, but generic baclofen tablets are inexpensive in the US. The liquid forms cost much more per milligram, and the 15 mg tablet is an odd one out at more than a dollar each.

Buying baclofen from outside the US

The FDA's personal importation page says: "In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S." It adds: "If a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import." The page says FDA personnel "may consider a more permissive decision" in some situations, which it lists, and states that "the FDA recommends only obtaining medicines from legal sources in the U.S."

Indian baclofen brands such as Liofen and Bacloheal are not FDA-approved products, and generic baclofen tablets are cheap in US pharmacies. Read the FDA page in full and check your own situation and your country's rules before ordering.

There is also a safety point specific to baclofen. Our shipping page gives 7 to 14 business days for standard registered shipping to the USA and Canada. Because stopping baclofen suddenly can cause seizures and hallucinations, an international parcel should never be your only supply. Keep enough local supply to cover delays, and never switch brands or strengths without your prescriber.

Baclofen on SafeRxPills

We sell two Indian baclofen brands: Liofen by Sun Pharmaceutical Industries and Bacloheal by Healing Pharma. A licensed pharmacist reviews prescriptions that customers upload. Prices as of 30 October 2026:

Product	Pack	Price	Per unit
Liofen 5 mg tablets	60 / 90 / 120	$19.00 / $26.00 / $34.00	$0.32 / $0.29 / $0.28
Liofen 10 mg tablets	30 / 60 / 90	$19.00 / $28.00 / $38.00	$0.63 / $0.47 / $0.42
Liofen 25 mg tablets	30 / 60 / 90	$35.00 / $55.00 / $77.00	$1.17 / $0.92 / $0.86
Bacloheal (baclofen) 10 mg tablets	100 / 200 / 300	$32.00 / $56.00 / $75.60	$0.32 / $0.28 / $0.25
Bacloheal (baclofen) 25 mg tablets	100 / 200 / 300	$40.00 / $70.00 / $94.50	$0.40 / $0.35 / $0.32
Liofen XL 10 mg capsules	30 / 60 / 90	$43.00 / $77.00 / $99.00	$1.43 / $1.28 / $1.10
Liofen XL 20 mg capsules	30 / 60 / 90	$55.00 / $99.00 / $133.00	$1.83 / $1.65 / $1.48
Liofen XL 30 mg capsules	30 / 60 / 90	$63.00 / $113.00 / $152.00	$2.10 / $1.88 / $1.69

Compared with the NADAC figures above, our per-tablet prices are higher than what US pharmacies pay for generic baclofen, and standard shipping is $25 on orders under $149. For most people with US insurance or access to a discount pharmacy, a local generic will be cheaper and faster. Our products may suit people who prefer a specific Indian brand, or who live in countries where local prices are higher.

Questions to ask your prescriber

• What dose am I aiming for, and how fast should I increase it?
• Should my dose be lower because of my kidney function or age?
• Which of my other medicines add to the drowsiness?
• What should I do if I miss doses or run out?
• If baclofen is not helping, how will we taper it?
• Am I planning a pregnancy, and does that change the plan?
• Is it safe to switch between tablets, liquid and capsules, or between brands?

Related guides

• Muscle relaxers compared: cyclobenzaprine, tizanidine, baclofen and carisoprodol
• Tizanidine dosage and the drug interactions that change it
• Cyclobenzaprine dosage: 5 mg vs 10 mg and the three week limit
• Pregabalin withdrawal: symptoms, timeline and how to taper
• Prescription medicine online: safety and buying guide

Sources

• Baclofen Tablets USP 10 mg and 20 mg, US prescribing information, Upsher-Smith Laboratories (DailyMed setid b2747a9d-5fca-4657-9e4b-4112607f30d8).
• Baclofen Tablets USP 10 mg and 20 mg, US prescribing information, Par Health, revised 07/2026 (DailyMed setid c17527be-661d-42f5-b6f6-56a681ba7870).
• LYVISPAH (baclofen) oral granules, US prescribing information, September 2026 (DailyMed setid 5b13c40d-a109-f838-e063-6294a90aecf2).
• OZOBAX DS (baclofen) oral solution 10 mg/5 mL, US prescribing information, Rosemont, March 2026 (DailyMed setid d8ddcec5-debe-42b4-a803-e65917cc6a54).
• FLEQSUVY (baclofen) oral suspension 25 mg/5 mL, US prescribing information, Azurity, December 2025 (DailyMed setid 9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa).
• GABLOFEN (baclofen injection) intrathecal, US prescribing information, Piramal Critical Care, May 2026 (DailyMed setid 00d3e846-dd92-448d-9ab8-6a07be823cc1); LIORESAL Intrathecal, Amneal, November 2025 (setid 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5).
• openFDA Drugs@FDA data for baclofen products, accessed 30 October 2026; DailyMed baclofen label listing, accessed 30 October 2026.
• Code of Federal Regulations, Title 21, Part 1308, Schedules of Controlled Substances, eCFR text as of 1 October 2026.
• Muller CA et al. High-dose baclofen for the treatment of alcohol dependence (BACLAD study). Eur Neuropsychopharmacol 2015. PMID 26048580.
• Beraha EM et al. Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence. Eur Neuropsychopharmacol 2016. PMID 27842939.
• Reynaud M et al. A randomized, placebo-controlled study of high-dose baclofen in alcohol-dependent patients: the ALPADIR study. Alcohol Alcohol 2017. PMID 28525555.
• Agabio R et al. Baclofen for alcohol use disorder. Cochrane Database Syst Rev 2023. PMID 36637087.
• Kotake K et al. Optimal dose of baclofen for the treatment of alcohol use disorder: a systematic review and dose-response meta-analysis. CNS Drugs 2025. PMID 40347309.
• Rolland B et al. Should the French approval of baclofen for alcohol dependence be extended to abstinence maintenance? Encephale 2025. PMID 39244501.
• ANSM. Baclofene Zentiva 10 mg: guide for prescribers, version 2.0, October 2021.
• CMS National Average Drug Acquisition Cost (NADAC), 2026 dataset, as of 28 October 2026.
• US FDA. Personal Importation. fda.gov, accessed 30 October 2026.