venasssten 506 Sleep disorders © cautions GENERAL CAUTIONS Avoid contact with broken skin - avoid contact with inflamed skin SPECIFIC CAUTIONS With topical use Avoid contact with eyes - avoid hot shower cor bath just before or ater application (burning sensation enhanced) avoid inhalation of vapours - not to be used under tight bandages » With transdermal use avoid contact with the face, scalp or in proximity to mucous membranes - avoid holding near eyes ‘or mucous membranes - recent cardiovascular events uncontrolled hypertension © SIDE-EFFECTS. GENERAL SIDE-EFFECTS » Uncommon Cough SPECIFIC SIDE-EFFECTS » Common or very common » With transdermal use Sensation abnormal > Uncommon » With transdermal use Atrioventricular block . eye irritation + ‘muscle spasms - nausea - palpitations peripheral oedema + skin reactions tachycardia. taste altered - throat irritation » Rare or very rare » With topical use Sneezing - watering eye > Frequency not known + With topical use Asthma exacerbated - dyspnoea «skin burning sensation (particularly iftoo much used or if administered more than 4 times di ‘@ MONITORING REQUIREMENTS » With transdermal use Monitor blood pressure during. treatment procedure, ‘© HANDLING AND STORAGE » With topical use Wash hands immediately after use (or wash hands 30 minutes after application ifhands treated). + With ansdermal se Nitrile gloves to be wom while handling patches and cleaning treatment areas (latex. gloves do not provide adequate protection). (© NATIONAL FUNDING/ACCESS DECISIONS QuTeNza® Scottish Medicines Consortium (SMC) decisions ‘The Scottish Medicines Consortium has advised (january 2011) that capsaicin 179 mg (8%) patch (Qutenza®) is accepted for restricted use within NHS Scotland for the ‘treatment of postherpetic neuralgia in patients who have not achieved adequate pain relief from, or who have not tolerated conventional first and second line treatments. ‘Treatment should be under the supervision of a specialist in pain management. ‘© MEDICINAL FORMS There can be variation inthe licensing of| different medicines containing the same drug. Forms available from special-order manufacturers include: cream ‘Cutaneous patch EXCIPIENTS: May contin Butylatedhyeronyansole > Qutenza (runenthal Ld) Capsaicin 179 mg Qutenoa 179mg cutaneous patches | 4 patch aH) £210.00 OT = £210.00, cream EXCIPIENTS: May contain Benyl alcoho, cetostearyl alcohol Gncluding cetyl and stearyacohol) asain Teva UK Ltd) (Capsaicin 750 microgram per 1 gram Axsain 0.075% cream | ‘4S gram (ow) £145807 = £1458 » Zacin (fea UK Lid) ‘Capsaicin 250 microgram per 1 gram Zach 0.025% cream | 45 gram (ok) £17.71 OF = £1771 7 Sleep disorders 7.1 Insomnia Hypnotics and anxiolytics Overview ‘Most anxiolytics (‘sedatives’) will induce sleep when given at night and most hypnotic will sedate when given during the day. Preseribing ofthese drugs is widespread but dependence (both physical and psychological) and tolerance ‘ecu. This may lead to difficulty in withdrawing the drug after the patient has been takingit regularly for more than a Few weeks. Hypnoties and anxiaties shoul therefore be reserved for short courses to alleviate acute conditions after causal factors have been established. Benzodiazepines are the most commonly used anxiolytics and hypnotics; they act at benzodiazepine receptors which fre assoctaved with gamuma-aminobutyric ald (GABA) receptors. Older drugs such as meprobamate p. 363 and barbiturates are not recommended—they have more side- effects and interactions than benzodiazepines and are much ‘more dangerous in overdosage. Benzodiazepine indications «© Benzodiazepines are indicated for the short-term relief (evo to four weeks only) of anxiety thatis severe, disabling or causing the patient unacceptable distress, ‘occurring alone or in association with insomnia or short- term psychosomatic, organic, or psychotic illness. ‘© The use of benzodiazepines to treat short-term ‘mild’ anxiety is inappropriate. «Benzodiazepines should be used to treat insomnia only when it is severe, disabling, or causing the patient extreme distress. Dependence and withdrawal ‘Withdrawal of a benzodiazepine should be gradual because abrupt withdrawal may produce confusion, toxic psychosis, convulsions, ora condition resembling delirium tremens. ‘The benzodiazepine withdrawal syndrome may develop at any time up to 3 weeks after stopping a long-acting benzodiazepine, but may occur within a day in the case of a short-acting one. Itis characterised by insomnia, anxiety, loss of appetite and of body-weight, tremor, perspiration, tinnitus, and perceptual disturbances. Some symptoms may bbe similar to the original complaint and encourage further prescribing; some symptoms may continue for weeks or ‘months after stopping benzodiazepines, Benzodiazepine withdrawal should be flexible and carried out at a reduction rate that is tolerable for the patient. The rate should depend on the i duration of use, and the patient's clinical response. Short- term users of benzodiazepines (2-4 weeks only) can usually taper off within 2~4 weeks. However, long-term users should bbe withdrawn over a much longer period of several months A suggested protocol for withdrawal for prescribed long term benzodiazepine paticnts is as follows: ‘© Transfer patient stepwise, one dose at a time over about a ‘week, to an equivalent daily dose of diazepam preferably taken at night. ‘© Reduce diazepam dose, usually by 1-2mg every 2- 4 weeks (in patients taking high doses of benzodiazepines, initially it may be appropriate to reduce the dose by up to ‘one-tenth every 1-2 weeks). IFuncomfortable withdrawal symptoms occu, maintain this dose until symptoms lessen. httos://t.me/allebookstoresBNF 80 ‘ Reduce diazepam dose further, if necessary in smaller steps; steps of 500 micrograms may be appropriate towards the end of withdrawal. Then stop completely. ‘* For long-term patients, the period needed for complete withdrawal may vary from several months to a year or more. Approximate equivalent doses, diazepam Smg = alprazolam 250 micrograms clobazam 10mg clonazepam 250 micrograms flurazepam 7.5-15mg chlordiazepoxide 12.5 mg loprazolam 0.5-1 mg lorazepam 500 micrograms lormetazepam 0.5-1 mg nitrazepam Smg ‘oxazepam 10mg temazepam 10mg Withdrawal symptoms for long-term users usually resolve within 6-18 months of the last dose. Some patients will recover more quickly, others may take longer. The addition of beta-blockers, antidepressants and antipsychotics should be avoided where possible. Counselling can be of considerable help both during and after the taper. Hypnotics Before a hypnotics prescribed the cause ofthe insomnia should be established and, where possible, underlying factors should be treated. However, it should be noted that some patients have unrealistic sleep expectations, and others understate their alcohol consumption which is often the cause of the insomnia, Short-acting hypnotics are preferable in patients with sleep onset insomnia, when sedation the following day is undesirable, or when prescribing for elderly patients. Long-acting hypnotics are Indicated in patients with poor sleep maintenance (e.g, early ‘morning waking) that causes daytime effects, when an anxiolytic effect is needed during the day, o when sedation the following day is acceptable. ‘Transient insomnia may occur in those who normaly sleep ‘well and may be due to extraneous factors such as noise, shift work, and jet lag. IFa hypnotic is indicated one that is rapidly eliminated should be chosen, and only one or two doses should be given Short-term insomnia usually related to an emotional problem or serious medical illness It may last fora few ‘weeks and may recur; a hypnotic can be useful bt should not be given for more than three weeks (preferably only one ‘week). Intermittent use is desirable with omission of some doses. A short-acting drug is usually appropriate, Chronic insomnia is rarely benefited by hypnotics and is sometimes due to mild dependence caused by injudicious prescribing of hypnotics. Psychiatrie disorders such as anxiety, depression, and abuse of drugs and alcohol are common causes. Sleep disturbance is very common in depressive illness and early wakening is often a useful pointer. The underlying psychiatric complaint should be treated, adapting the drug regimen toalleviate insomnia. For example, clomipramine hydrochloride p. 391 or mirtazapine 13 prescrihed for depression will len help to promote sleep iftaken at night. Other causes of insomnia include daytime cat-napping and physical causes such as pain, pruritus, and dyspnoea, Hypnotics should not be prescribed indiscriminately and routine prescribing is undesirable. They should be reserved for short courses in the acutely distressed. Tolerance to their effects develops within 3to.14 days of continuous use and long-term efficacy cannot be assured. A major drawback of long-term use is that withdrawal can cause rebound insomnia and a withdrawal syndrome. Insomnia 507 ‘Where prolonged administration is unavoidable hypnotics should be discontinued as soon as feasible and the patient warned that sleep may be disturbed for a few days before normal rhythm is re-established; broken sleep with vivid dreams may persist for several weeks. Elderly Benzodiazepines and the Zdrugs should be avoided in the elderly, because the elderly are at greater risk of becoming ataxic and confused, leading to falls and injury. Dental patients ‘Some anxious patients may benefit from the use of hypnoties during dental procedures such as temazepam p. 509 or diazepam p. 360. Temazepam is preferred when itis important to minimise any residual effect the following day. Benzodiazepines Benzodiazepines used as hypnotics include nitrazepam p. 509 and flurazepam p. 508 which have a prolonged action and may give rise to residual effects on the following day; repeated doses tend to be cumulative. Loprazolam p. 508, lormetazepam p. $09, and temazepam act fora shorter time and they have little or no hangover effect. Withdrawal phenomena are more common with the short-acting benzodiazepines. Ifinsomnia is associated with daytime anxiety then the use ofa long-acting benzodiazepine anxiolytic such as diazepam given as a single dose at night may effectively treat both symptoms. Zolpidem, and zopiclone Zolpidem tartrate p. 512 and zopiclone p.512 are non- benzodiazepine hypnotics (sometimes referred to as 2- drugs), but they act at the benzodiazepine receptor. They are not licensed for long-term use; dependence has been reported in a small number of patients. Both zolpidem. tartrate and zopiclone have a short duration of action. Choral and derivatives ‘There is no convincing evidence that they are particularly Useful in the elderly and thei role as hypnotics is now very limited. Clomethiazole Clomethiazole p. 511 may be a useful hypnotic for elderly patients because of its freedom from hangover but, as with all hypnotics, routine administration is undesirable and dependence occurs. Antihistamines Some antihistamines such as promethazine hydrochloride p. 301 are on sale tothe public for occasional insomnia; their prolonged duration of action can often cause drowsiness the following day. The sedative effect of antihistamines may diminish after a few days of continued treatment; antihistamines are associated with headache, psychomotor impeiment and antimuscarinic effects. interferes with sleep during the latter part of the night. Alcohol also disturbs sleep patterns, and so can worsen sleep disorders. Melatonin ‘Melatonin p.512 Isa pineal losmone; is licensed for Une short-term treatment of insomnia in adults over 55 years; and for the short-term treatment of jet-lag in adults. Anxiolytics Benzodiazepine anxiolytics can be effective in alleviating anxiety states. Although these drugs are sometimes prescribed for stress-related symptoms, unhappiness, or ‘minor physical disease, their use in such conditions is, inappropriate. Benzodiazepine anxiolytics should not be used as sole treatment for chronic anxiety, and they are not appropriate for treating depression or chronic psychosis. In httos://t.me/allebookstores Nervous system avenasssten 508 Sleep disorders bereavement, psychological adjustment may be inhibited by benzodiazepines. ‘Anxiolytic benzodiazepine treatment should be limited to the lowest possible dose for the shortest possible time. Dependence is particularly likely in patients with a history of alcohol or drug abuse and in patients with marked personality disorders. ‘Some antidepressant drugs are licensed for use in anxiety and related disorders. Some antipsychotic drugs, in low doses, are also sometimes used in severe anxiety for their sedative action, but long-term use should be avoided because of the risk of adverse effects. The use of antihistamines (e.g. hydroxyzine hydrochloride p. 299) for their sedative effect in anxiety is not appropriate. Beta-adrenoceptor blocking drugs do not affect psychological symptoms of anxiety, such as worry, tension, and fear, but they do reduce autonomic symptoms, such as palpitation and tremor; they do not reduce non-autonomic symptoms, such as muscle tension. Beta-blockers are therefore indicated for patients with predominantly somatic Symptoms; this, intum, may prevent the onset of worry and ar. Benzodiazepines Benzodiazepines are indicated for the short-term relief of severe anxiety; long-term use should be avoided. Diazepam, alprazolam p. 360, chlordiazepoxide hydrochloride p. 360, and ctobazam p. 353 have a sustained action. Shorter-acting ‘compounds such as lorazepam p. 355 and oxazepam p. 362 ‘may be preferred in patients with hepatic impairment but they carry a greater risk of withdrawal symptoms. In panic disorders (with or without agoraphobia) resistant to antidepressant therapy, a benzodiazepine may be used alternatively, a benzodiazepine may be used as short-term adjunctive therapy at the start of antidepressant treatment to prevent the initial worsening of symptoms. Diazepam or lorazepam are very occasionally administered intravenously for the control of panic attacks. This route is the most rapid but the procedure is not without risk and should be used only when alternative measures have failed, ‘The intramuscular route has no advantage over the oral route. Buspirone Buspirone hydrochloride p. 358 is thought to act at specific serotonin (SHT,4) receptors. Response to treatment may take up to 2 weeks. It does not alleviate the symptoms of benzodiazepine withdrawal. Therefore a patient taking a benzodiazepine still needs to have the benzodiazepine ‘withdrawn gradually; itis advisable to do this before starting ‘buspirone hydrochloride. The dependence and abuse potential of buspirone hydrochloride is low; itis, however, licensed for short-term use only (but specialists occasionally use it for several months). Meprobamate ‘Meprobemate p. 363 is less effective than the benzodiazepines, more hazardous in overdosage, and can also induce dependence. It is not recommended. Barbiturates ‘The intermediate-acting barbiturates have a place only in the froatmont of seuere intractable insomnia in patients already taking barbiturates; they should be avoided in the elderly. Intermediate-acting barbiturate preparations containing amobarbital sodium, butobarbital, and ‘secobarbital sodium are available on a named patient basis. ‘The long-acting barbiturate phenobarbital is still sometimes of value in epilepsy but its use asa sedative is unjustified. ‘The very short-acting barbiturate thiopental sodium p. 354 is used in anaesthesia Increased hostility and aggression after barbiturates and alcohol usually indicates intoxication. BNF 80 HYPNOTICS, SEDATIVES AND ANXIOLYTICS ) BENZODIAZEPINES Flurazepam INDICATIONS AND DOSE ‘Insomnia (short-term use) » eymourH > Adult: 15-30 mg once daily, dose to be taken at bedtime, for debilitated patients, use elderly dose , dose to be taken at bedtime © CONTRA-INDICATIONS Respiratory depression © CAUTIONS Acute porphyrias p. 1120 -hypoalbuminaemia muscle weakness CAUTIONS, FURTHER INFORMATION » Paradoxical effects A paradoxical increase in hostility and aggression may be reported by patients taking benzodiazepines. The effects range from talkativeness and excitement to aggressive and antisocial acts. Adjustment of the dose (up or down) sometimes attenuates the impulses. Increased anxiety and perceptual disorders are other paradoxical effects. (@ INTERACTIONS > Appendix 1: furazepam SIDE-EFFECTS » Common or very common Taste altered Rare or very rare Abdominal discomfort . skin eruption, » Frequency not known Agranulocytosis - extrapyramidal symptoms leucopenia - pancytopenia - suicide attempt - thrombocytopenia (@ BREAST FEEDING Benzodiazepines are present in milk, and should be avoided if possible during breast-feeding. (© HEPATIC IMPAIRMENT Dose adjustments Manufacturer advises dose of 15mgin mild to moderate impairment. (© RENAL IMPAIRMENT Dose adjustments Start with small doses in severe impairment. (@ NATIONAL FUNDING/ACCESS DECISIONS [NHS restrictions Flurazepam capsules are not prescribable in NHS primary care. (© MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Capsule (CAUTIONARY AND ADVISORY LABELS 19, » Dalmane (Mylan) Flurazepam (as Furazepam hydrochloride) 15 mg Dalmane 15mg apsiles | 30 capsule Bo) £6.73 CD81) Flurazepam (as Flurazepam hydrochloride) 30 mg Dalmane 30mg capsules | 30 capsule FoR £8.03 CDE) I Loprazolam 05 now-2019 INDICATIONS AND DOSE {Insomnia (short-term use) » pyMouTH » Adult: 11mg once daily, then increased to 1.5-2 mg once daily ifrequired, dose to be taken at bedtime, for debilitated patients, use elderly dose » Elderly: 0.5-1 mg once daily, dose to be taken at bedtime ‘© CONTRA-INDICATIONS Respiratory depression ‘@ CAUTIONS Acute porphyrias p. 1120-hypoalbuminaemia- muscle weakness CAUTIONS, FURTHER INFORMATION + Paradoxical effects A paradoxical increase in hostility and aggression may be reported by patients taking benzodiazepines. The effects range from talkativeness and httos://t.me/allebookstoresBNF 80 excitement to aggressive and antisocial acts. Adjustment of the dose (up or down) sometimes attenuates the impulses. Increased anxiety and perceptual disorders are other paradoxical effects. ‘@ INTERACTIONS + Appendix 1: loprazolam © SIDE-EFFECTS Adjustment disorder: cognitive disorder ‘muscle tone decreased - speech disorder (@ BREAST FEEDING Benzodiazepines are present in milk, and should be avoided if possible during breast-feeding. (© RENAL IMPAIRMENT Dose adjustments Start with small doses in severe impairment. ‘© MEDICINAL FORMS There can be variation inthe licensing of| different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 19 » Loprazolam (Non-proprietary) Loprazolam (as Loprazolam mesilate) 1 mg Loorazolam mg tablets | 28 tablet Fax) £18.00-£27.00 OT = £22.50) I Lormetazepam 02019 © INDICATIONS AND DOSE {Insomnia (short-term use) > BY MOUTH » Adult; 0.5-1.5 mg once daily, dose to be taken at bedtime, for debilitated patients, use elderly dose » Elderly: 500 micrograms once daily, dose to be taken at bedtime ‘© CONTRA-INDICATIONS Not for use alone to treat insomnia associated with depression -respiratory depression © CAUTIONS Acute porphyrias p. 1120 - hypoalbuminaemia muscle weakness CAUTIONS, FURTHER INFORMATION » Paradoxical effects A paradoxical increase in hostility and aggression may be reported by patients taking benzodiazepines. The effects range from talkativeness and excitement to aggressive and antisocial acts. Adjustment cof the dose (up or down) sometimes attenuates the impulses. Increased anxiety and perceptual disorders are other paradoxical effects. (@ INTERACTIONS +» Appendix 1: lormetazepam SIDE-EFFECTS > Common or very common Asthenia > Rareor very rare Agranulocytosis allergic dermatitis apnoea appetite change «coma - constipation + disinhibition extrapyramidal symptoms - hyponatraem hypothermia leucopenia - memory loss - obstructive pulmonary disease exacerbated . pancytopenia «saliva altered - sexual dysfunction - SIADH - speech slurred - thrombocytopenia » Frequency not known Suicide attempt (© BREAST FEEDING Benzodiazepines are present in milk, and should be avoided if possible during breast-feeding. (© RENAL IMPAIRMENT Dose adjustments Start with small doses in severe impairment ‘© MEDICINAL FORMS There can be variation inthe licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension Tablet CAUTIONARY AND ADVISORY LABELS 19 > Lormetazepam (Non-proprietary) Lormetazepam 500 microgram Lormetazepam 0Omicrogram tablets | 30 tablet GH) £64.17 OT = £1907 (COE) ‘Lormetazepam 1 mg Lormetazepam img tables | 30 tablet S1778 OT = 1778(C0E0) Insomnia 509 Thi razepam (05-Nov 2019 ‘© INDICATIONS AND DOSE {Insomnia (short-term use) > ey MOUTH » Adult: 5~10 mg daily, dose to be taken at bedtime, for debilitated patients, use elderly dose » Elderly: 2.5-5 mg daily, dose to be taken at bedtime ‘@ CONTRA-INDICATIONS Chronic psychosis respiratory depression ‘© CAUTIONS Acute porphyrias p. 1120- hypoalbuminaemia- muscle weakness CAUTIONS, FURTHER INFORMATION » Paradoxical effects A paradoxical increase in hostility and aggression may be reported by patients taking ‘benzodiazepines. The effects range from talkativeness and, excitement to aggressive and antisocial acts. Adjustment of the dose (up or down) sometimes attenuates the impulses, Increased anxiety and perceptual disorders are other paradoxical effects. (@ INTERACTIONS > Appendix 1: nitrazepam (SIDE-EFFECTS » Common or very common Movement disorders » Uncommon Concentration impaired » Rare or very rare Abdominal distress - muscle cramps- psychiatric disorder -skin reactions -Stevens-Johnson syndrome » Frequency not known Drug abuse ‘¢ BREAST FEEDING Benzodiazepines are present in milk, and should be avoided if possible during breast-feeding. (© RENAL IMPAIRMENT Dose adjustments Start with small doses in severe impairment. ‘© MEDICINAL FORMS There can be variation inthe licensing of different medicines contalning the same drug. Forms avallable from special-order manufacturers include: oral suspension Oral suspension CAUTIONARY AND ADVISORY LABELS 19 » Nitrazepam (Non-proprietary) Nitrazepam 500 microgram per 1 ml Nirazepam 2.5m oral suspension | TOmm (eH) £114.00 0T = £114.00 (B31) Tablet CAUTIONARY AND ADVISORY LABELS 19 > Nitrazepam (Non-proprietary) Nitrazepam 5 mg Nitrazepam mg tablets | 28 tablet PSH) £10.22 r= @2.17@e) > Mogadon (Mian) Nitrazepam 5 mg Mogadon sme tablets | 30 tablet FH) $5.7608:] Fremazepam osao ‘© INDICATIONS AND DOSE Insomnia (short-term use) » By MOUTH Adult: 10-20 mg once daily, alternatively 30-40 mg ‘once daily, higher dose range only to he administered in exceptional circumstances, dase to be taken at bedtime, for debilitated patients, use elderly dose + Elderly: 10 mg once daily, alternatively 20 mg once daily, higher dose only to be administered ‘exceptional circumstances, dose to be taken at bedtime Conscious sedation for dental procedures » By MOUTH » Adult; 15-30 mg, tobe administered 30-60 minutes before procedure continued > httos://t.me/allebookstores Nervous system avenasssten 510 Sleep disorders Premedication before surgery or investigatory procedures > BY MOUTH » Adult: 10-20 mg, to be taken 1~2 hours before procedure, alternatively 30 mg, to be taken 1-2 hours before procedure, higher alternate dose only administered in exceptional circumstances » Elderly: 10mg, to be taken 1-2 hours before procedure, alternatively 20 mg, to be taken 1-2 hours before procedure, higher alternate dose only administered in exceptional circumstances (© UNLICENSED USE Temazepam doses in BNF may differ from those in product literature. Not licensed for conscious sedation for dental procedures. ‘© CONTRA-INDICATIONS Chronic psychosis - CNS depression “compromised airway - respiratory depression ‘© CAUTIONS Hypoalbuminaemia - muscle weakness organic brain changes CAUTIONS, FURTHER INFORMATION > Paradonical effects A yaraduaival increase iu hus aggression may be reported by patients taking benzodiazepines. The effects range from talkativeness and excitement to aggressive and antisocial acts. Adjustment of the dose (up or down) sometimes attenuates the impulses. Increased anxiety and perceptual disorders are other paradoxical effects. (© INTERACTIONS > Appendix 1: temazepam ‘© SIDE-EFFECTS. Drug abuse dry mouth - hypersalivation speech slurred (© BREAST FEEDING Benzodiazepines are present in milk, and should be avoided if possible during breast-feeding. (@ HEPATIC IMPAIRMENT Dose adjustments » When used for Insomnia Manufacturer advises initiate at S mg once daily, increase to 10mg or 20mg once daily in extreme cases. Dose to be taken at bedtime, (© RENAL IMPAIRMENT Dose adjustments Start with small doses in severe impairment. (@ PATIENT AND CARER ADVICE Driving and skilled tasks Patients given sedatives and analgesics during minor outpatient procedures should be very carefully warned about the risks of undertaking skilled tasks (e.g. driving) afterwards. Responsible persons should be available to take patients home afterwards. The dangers of taking alcohol should be emphasised. ‘© PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary ‘Temazepam Tablets and Oral Solution may be prescribed. y aud ‘© MEDICINAL FORMS There can be variation inthe licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral ral solution CAUTIONARY AND ADVISORY LABELS 19 » Temazepam (Non-proprietary) TTemazepam 2 mg per 1 mi Temazepam 10ng/Sm oral solution sugar fre 1300 ml (FSH) £183.20 of = £163.20 EO) Tablet (CAUTIONARY AND ADVISORY LABELS 19 » Temazepam (Non-propritary) Temazepam 10 mg Temazepam omg tablets | 28 tablet FOE] £35.00 DT = £.62/CD | 500 tablet Por) £26.07-£624.2 (C03) 20 mg_Temazeoam 20mg tablets | 28 abet oH) £35.00 DT = €1.56|CD3) | 250 tablet Bau) £13.93-£20794 D3) BNF 80 HYPNOTICS, SEDATIVES AND ANXIOLYTICS > NON-BENZODIAZEPINE HYPNOTICS AND SEDATIVES chioral hydrate ‘20-May-2020 INDICATIONS AND DOSE {Insomnia (short-term use) using chloral hydrate 143.3 mg/5 mL oral solution > BY MOUTH UsiNG ORAL soLUTION > Adult: 430-860 mg once dally (max. per dose 2 ), dose tobe taken with water or milk at bedtime Insomnia (short-term use), using chloral betaine 707 mg (= 414 mg chloral hydrate) tablets » BY MOUTH USING TABLETS > Adult: 1-2 tablets, alternatively 414-828 mg once daily, ose tobe taken with water or milk at bedtime; ‘maximum 4 tablets per day; maximum 2g per day (© CONTRA-INDICATIONS Acute porphytias p. 1120. gastritis « severe cardiac disease ‘© CAUTIONS Avoid contact with mucous membranes - avoid contact with skin - avoid prolonged use (and abrupt ‘withdrawal thereafter) -reduce dose in fail elderly INTERACTIONS > Appendix 1: chloral hydrate © SIDE-EFFECTS Agitation -allergic dermatitis - ataxia confusion - delirium (more common on abrupt discontinuation) -drug use disorders gastrointestinal discomfort - gastrointestinal disorders -headache injury ketonuria -kidney injury (© PREGNANCY Avoid. ‘© BREAST FEEDING Risk of sedation in infant—avoid. @ HEPATIC IMPAIRMENT Manufacturer advises avoid in ‘marked impaisment Dose adjustments. Manufacturer advises consider dose reduction in the elderly with hepatic impairment. ‘© RENALIMPAIRMENT Avoid in severe impaitment. ¢ DIRECTIONS FOR ADMINISTRATION For administration by ‘mouth dilute liquid with plenty of water or juice to mask unpleasant taste. ‘© PRESCRIBING AND DISPENSING INFORMATION Flavours of oral liquid formulations may include black currant. (© PATIENT AND CARER ADVICE Driving and skilled tasks Drowsiness may persist the next day and affect performance of skilled tasks (e.g, driving); effects of alcohol enhanced. © LESS SUITABLE FOR PRESCRIBING Chloral hydrate is less suitable for preseribing in insomnia, (© MEDICINAL FORMS There can be variation inthe licensing of fferent medicines containing the samme drug. Forms available from special-order manufacturers include: oral suspension, oral solution, suppository, enema Tablet (CAUTIONARY AND ADVISORY LABELS 19,27 » Chloral hydrate (Non-proprietary) Clral betaine 707 mg. Cloral betaine 77mg tablets | 30 tablet aH) £138.59 0T= £138.59 oral calution CAUTIONARY AKD ADVISORY LABELS (paediatric solution only), 19, (Golution other than paediatric ony), 27 » Choral hydrate (Non-proprietary) Chloral hydrate 28.66 mg per 1 ml chloral nyrate143.3mg/Smi al solution B | 150 i Bab] £244.25 DT» £244.25 httos://t.me/allebookstoresBNF 80 Insomnia 511 Tclomethiazole (Chlormethiazole) oe t2008 ‘© INDICATIONS AND DOSE Severe insomnia (short-term use) > BY MOUTH USING CAPSULES + Elderly: 192-384 mg once daily, dose to be taken at bedtime > BY MOUTH USING ORAL SOLUTION > Elderly: 5-10 ml. once daily, dose to be taken at bedtime Restlessness and agitation > BY MOUTH USING CAPSULES > Elderiy: 192 mg 3 times a day > BY MOUTH USING ORAL SOLUTION » Elderiy: 5SmL3 times a day ‘Alcohol withdrawal > BY MOUTH USING CAPSULES » Adult: Initially 2-4 capsules, to be repeated if necessary after same henirs.9=12 capsailes daily in 3-4 divided doses on day 1 ¢first 24 hours), then 6-8 capsules daily in 3-4 divided doses on day 2, then 4-6 capsules daily in 3~4 divided doses on day 3, dose then to be gradually reduced over days 4-6, total duration of treatment for no more than 9 days > BY MOUTH USING ORAL SOLUTION » Adult: Initially 10-20 mL, to be repeated ifnecessary after some hours, then 45-60 ml. daily in 3-4 divided doses on day 1 (first 24 hours), then 30~40 mL day in 3-4 divided doses on day 2, then 20-30 mL daily in 3-4 divided doses on day 3, dose then to be gradully reduced over days 4~6, total duration of treatment for no more than 9 days ‘© CONTRA-INDICATIONS. Acute pulmonary insuticiency- alcohol-dependent patients who continue to drink ‘© CAUTIONS Avoid prolonged use (and abrupt withdrawal thereafter) - cardiac disease (confusional state may indicate hypoxia). chronic pulmonary insufficiency - elderly -excessive sedation may occur (particularly with higher doses); -history of drug abuse - marked personality disorder - respiratory disease (confusional state may icate hypoxia) sleep apnoea syndrome {INTERACTIONS » Appendix 1:clomethiazole (SIDE-EFFECTS Agitation - bronchial secretion increased confusion - conjunctival irritation -drug dependence - excessive sedation - gastrointestinal disorder -hangover - nasal complaints skin reactions -upper airway secretion increased it possible—especally during the frst and third trimesters. © BREAST FEEDING Use only if benefit outweighs risk— present in breast milk but effets unknown, © HEPATIC IMPAIRMENT Manufacturer advises caution in moderate to severe impairment (risk of increased exposure Dose adjustments Manufacturer advises consider dose reduction in moderate hepatic disorders associated with alcoholism. (© RENAL IMPAIRMENT Increased cerebral sensitivity Dose adjustments Start with small doses in severe impairment. «PATIENT AND CARER ADVICE Driving and siled tacks Drowsiness may persist the next day and affect performance of skilled tasks (e.g. driving); effets of alcohol enhanced ‘© MEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Oral solution CAUTIONARY AND ADVISORY LABELS 19 EXCIPIENTS: May contain Alcotol > Clomethiazole (Non-proprietary) ‘Clomethiazoe (as Clomethiazole edsilate) 50 mg per Lm Gomethiazole 31.5mq/m| oral solution sugar-free | 300ml Capsule CAUTIONARY AND ADVISORY LABELS 19 > Clomethiazole (Non-proprietary) ‘Clomethiazole 192 mg Clometiazole 192mg capsules | ‘co capsule oH) £32.800T «£32.80 FMelatonin sower2n20 ‘@ INDICATIONS AND DOSE {Insomnia [short-term use] > BY MOUTH USING MODIFIED-RELEASE TABLETS > Adult 85 years and aver: 2:mg once daily for: 13 weeks, dose to be taken 1-2 hours before bedtime Jet lag [short-term use] > BY MOUTH USING IMMEDIATE-RELEASE MEDICINES > Adult: 3 mg once daily, increased if necessary to 6 mg. ‘once daily for up to 5 days, the first dose should be taken at the habitual bedtime after arrival at destination. Doses should not be taken before Spm or after 4am, Maximum of 16 treatment courses per year {Insomnia in patients with learning disabilities [where ‘sleep hygiene measures have been insufficient] (initiated under specialist supervision) » BY MOUTH USING MODIFIED-RELEASE TABLETS > Adult: Initially 2mg once daily, increased if necessary tad-6 mg once daily, dase to he taken 30-60 minutes before bedtime; maximum 10 mg per day PHARMACOKINETICS + The intake of food with immediate-release melatonin, may increase the bioavailability of melatonin © UNLICENSED USE [GA Melatonin is used for insomnia in patients with learning disabilities, <€ but isnot licensed for this indication. © CAUTIONS Autoimmune disease (manufacturer advises, avoid—no information available) ¢@ INTERACTIONS » Appendix: 1: melatonin @ SIDE-EFFECTS » Common or very common Arthralgia headaches - increased risk of infection pain » Uncommon Anxiety -asthenia chest pain dizziness. drowsiness -dry mouth - gastrointestinal discomfort - hyperbilirubinaemia- hypertension - menopausal symptoms. mood altered - movement disorders -nausea night sweats -oral disorders -skin reactions. sleep disorders urine abnormalities - weight increased » Rare or very rare Aggression angina pectoris -arthritis- coneentration impaired -erying - depression - disorientation -electrolyte imbalance excessive tearing - gastrointestinal disorders haematuria hot flush ypertistyceridaemia - leucopenia -memory loss muscle complaints -nail disorder palpitations paraesthesia partial complex seizure - prostatitis -sexual dysfunction syncope thirst - thrombocytopenia urinary disorders - vertigo vision disorders vomiting » Frequency not known Angioedema- galactorrhoea- hypergivcaemia ‘¢ PREGNANCY No information available—avoid, (© BREAST FEEDING Present in milk—avoid. (© HEPATIC IMPAIRMENT. Manufacturer advises avoid (risk of decreased clearance; limited information available). httos://t.me/allebookstores Nervous system avenasssten 512 Sleep disorders ‘© RENALIMPAIRMENT No information available—use with caution © DIRECTIONS FOR ADMINISTRATION Manufacturers advise that modified-release tablets should be taken with or after food. Licensed immediate-release formulations should be taken on an empty stomach, 2 hours before or 2 hours after food—intake with carbohydrate-rich meals may impair blood glucose control ‘© MEDICINAL FORMS There can be variation inthe licensing of different medicines containing the same drug, Forms available from special-order manufacturers include: tablet, modified release tablet, ora solution \Modified-retease tablet (CAUTIONARY AND ADVISORY LABELS 2,21, 25, » Melatonin (Non-proprietary) Maatonn 3g Met ang mode eee ae s) Circadin (yan Pharma Lo) Melatonin 2 mg Circadin2mg mosiied-elease tablets | 30 tablet om) £1539 0T = £1539 Slenyto (Flynn Pharma Lid) Melatonin mg Siento Img moctied-elease tables | Tablet (CAUTIONARY AND ADVISORY LABELS 2,25 » Melatonin (Non-proprietary) Melatonin img Melatonin 1mg tablets | 90 tablet, Melatonin 3 mg Melatonin 3m tables | 30 tablet BH] £15.95 $65.000T= £52.74 Melatonin 5 mg Melatonin Gara strength Smg tablets | 0 tablet \esPro imported (United states) Melatonin 500 microgram VesPro Melatonin Sd0microgram tablets | 2000 tablet oral solution [CAUTIONARY AND ADVISORY LABELS 2 EXCIPIENTS: May contin Ethanol, propylene goo, sorbitol » Melatonin (Non-proprietary) Melatonin img per 1m Melatonin Lmg/ ora solution sugar-free |/250 mi au) £130.00 07 = £130.00 I Zolpidem tartrate orFeb2019 ‘© INDICATIONS AND DOSE ‘Insomnia (short-term use) for up to 4 weeks, dose to be taken at ted patients, use elderly dose » Elderly: 5mg daily for up to 4 weeks, dose to be taken at bedtime ‘© CONTRA-INDICATIONS Acute respiratory depression - ‘marked neuromuscular respiratory weakness obstructive sleep apnoea psychotic illness severe respiratory depression - unstable myasthenia gravis ‘© CAUTIONS Avoid prolonged use (and abrupt withdrawal thereafter) - depression - elderly -history of alcohol abuse - history of drug abuse - muscle weakness - myasthenia, gravis CAUTIONS, FURTHER INFORMATION » Elderly For hypnotic Z-drugs, prescription potentially inappropriate (STOPP criteria) in elderly (may cause protracted daytime sedation and/or ataxia). See also Prescribing in the elderly p. 33. © INTERACTIONS > Appendix 1: zolpidem SIDE-EFFECTS » Common or very common Abdominal pain anterograde ‘amnesia - anxiety back pain diarrhoea dizziness - fatigue hallucination - headache «increased risk of infection + nausea sleep disorders - vomiting BNF 80 > Uncommon Confusion - diplopia irritability > Frequency not known Angioedema behaviour abnormal - concentration impaired delusions - depression - drug dependence- fall- gait abnormal -hepatic disorders hyperhidrosis level of consciousness decreased -libido disorder -muscle weakness - psychosis -respiratory depression skin reactions - speech disorder - withdrawal syndrome (¢ PREGNANCY Avoid regular use (isk of neonatal withdrawal symptoms); high doses during late pregnancy or labour may cause neonatal hypothermia, bypotonia, and respiratory depression. BREAST FEEDING Small amounts present in milk—avoid. ‘¢ HEPATIC IMPAIRMENT Manufacturer advises caution in mild to moderate impairment risk of decreased clearance); avoid in severe impairment. Dose adjustments Manufacturer advises initial dose reduction to 5 mg daily in mild to moderate impairment. © RENAL IMPAIRMENT Use with caution. (PATIENT AND CARER ADVICE Driving and skiled tasks Drowsiness may persist the next day—leave at least 8 hours between taking zolpidem and performing skilled tasks (e.g. driving, or operating machinery); effects of alcohol and other CNS depressants enhanced. ¢¢ NATIONAL FUNDING/ACCESS DECISIONS NICE decisions > Guidance onthe use of zaleplon, zolpidem, and zopiclone for the short-term management of insomnia (April 2004) Nice TAT? Zolpidem is recommended for the short-term ‘management of severe insomnia that interferes with normal dail if, and should be prescribed for short periods of time only. warwniceorg.uk/guidanceyta77 (© MEDICINAL FORMS There can be variation in the licensing of, different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 19, > Zolpidem tartrate (Nor-proprietary) Zolpidem tartrate 5 mg. Zolpidem Smg tablets | 28 tablet i) £50801 =£2.90CDE) Zolpidem tartrate 10 mg Zopidem 10m tables | 28 tablet £44801 = £15208) » Stilact (Sano) Zolpidem tartrate mg stinoct Smg tablets | 28 abet 5H] £1.10 Dr=290@o4) Zolpidem tartrate 10 mg stiloct 10mg tables | 28 tablet £10001 =1.52(be) I Zopiclone careb2019 INDICATIONS AND DOSE {Insomnia (short-term use) > BYMOUTH » Adult: 7.5 mg once daily for up to 4 weeks, dose to be taken at bedtime + Elderly: Initially 3.75 mg once daily for up to-4 weeks, dose to be taken at bedtime, increased if necessary to 7.5 mg daily ‘Insomnia (short-term use) in patients with chronic pulmonary insufficiency > By mouTH Adult: Initially 3.75 mg once daily for up to 4 weeks, dose to be taken at bedtime, increased if necessary to 1.5 mg daily ‘© CONTRA-INDICATIONS Marked neuromuscular respiratory weakness «respiratory failure «severe sleep apnoea syndrome - unstable myasthenia gravis httos://t.me/allebookstores